Canadian Humira Post Marketing Observational Epidemiological Study: Assessing Effectiveness in Psoriasis (Complete-PS)

November 18, 2019 updated by: AbbVie (prior sponsor, Abbott)
This was a Canadian post-marketing observational study (PMOS) utilizing a prospective cohort design that compared the real - life effectiveness of adalimumab to topical and traditional systemic agents in the management of psoriasis and its impact on the patient's quality of life and societal burden of illness.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This was a Canadian post-marketing observational study (PMOS) utilizing a prospective cohort design. Participants were entered into one of two study cohorts (adalimumab cohort or topical/traditional systemic cohort) at the time of change of their psoriasis treatment for any reason and were followed for a maximum of 24 months with recommended assessments at 3, 6, 12, 18 and 24 months after baseline. Treatment of the participants and follow up were according to the physician's judgment, regional regulations, and the product monograph. Off-label use was not permitted, and these participants were not included in the study. Dose changes including escalation were allowed as per the physician's judgment for participants that were treated as per indication when they were enrolled in the study.

Study Type

Observational

Enrollment (Actual)

662

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2G 1B1
        • Kirk Barber Research, CA /ID# 57722
      • Calgary, Alberta, Canada, T2T 5C7
        • Richmond Road Diagnostic Treat /ID# 70913
      • Calgary, Alberta, Canada, T3A 2N1
        • Institute for Skin Advancement /ID# 66782
      • Edmonton, Alberta, Canada, T5N 4B2
        • Thomas Nakatsui P.C. /ID# 55080
      • Edmonton, Alberta, Canada, T6G 1C3
        • Alberta DermaSurgery Centre /ID# 75513
    • British Columbia
      • Nanaimo, British Columbia, Canada, V9T 1W1
        • Wellington Medical Clinic Ltd. /ID# 55083
      • Victoria, British Columbia, Canada, V8V 3M9
        • Percuro Clinical Research, Ltd /ID# 54563
    • Manitoba
      • Brandon, Manitoba, Canada, R7A 0L5
        • Jason Ronald Sneath Medical Co /ID# 138026
      • Winnipeg, Manitoba, Canada, R3C 1T6
        • Winnipeg Clinic, Manitoba, CA /ID# 56865
    • New Brunswick
      • Bathurst, New Brunswick, Canada, E2A 4X7
        • Maritime Medical Reseach Cente /ID# 128775
      • Fredericton, New Brunswick, Canada, E3B 1G9
        • Dr. Irina Turchin PC Inc. /ID# 66029
      • Moncton, New Brunswick, Canada, E1C 8X3
        • Dermatologue Inc. /ID# 76074
      • Quispamsis, New Brunswick, Canada, E2E 4Z4
        • Douglas N. Keeling MD Dermatol /ID# 55098
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1A 4Y3
        • Karma Clinical Trials /ID# 55101
      • St. John's, Newfoundland and Labrador, Canada, A1B 5E8
        • Nexus Clinical Research /ID# 56403
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 0A2
        • Eastern Canada Cutaneous Resea /ID# 46353
    • Ontario
      • Barrie, Ontario, Canada, L4M 7G1
        • SimcoDerm Medical and Surgical /ID# 96915
      • Etobicoke, Ontario, Canada, M8X 1Y9
        • Kingsway Clinical Research /ID# 97255
      • Hamilton, Ontario, Canada, L8N 1Y2
        • Dermatrials Research /ID# 124138
      • London, Ontario, Canada, N6H 5L5
        • Dr. Wei Jing Loo Medicine Prof /ID# 127546
      • Markham, Ontario, Canada, L3P 1X2
        • Lynderm Research Inc. /ID# 63206
      • Mississauga, Ontario, Canada, L4Y 1A6
        • Toronto Regional Wound Healing /ID# 55135
      • Mississauga, Ontario, Canada, L5M 2V8
        • Dr. Anna Hinek Medicine Prof /ID# 148305
      • Oakville, Ontario, Canada, L6J 7W5
        • Oakville Derma and Laser, CA /ID# 55130
      • Peterborough, Ontario, Canada, K9J 5K2
        • Dr. Melinda Gooderham Medicine /ID# 54566
      • Richmond Hill, Ontario, Canada, L4C 9M7
        • York Dermatology Center /ID# 127786
      • St-catharines, Ontario, Canada, L2R 5W4
        • Specialized Dermatology Inc. /ID# 64031
      • Sudbury, Ontario, Canada, P3C 1X8
        • Giroux, Sudbury, CA /ID# 55128
      • Thornhill, Ontario, Canada, L4J 3M6
        • Lori Shapiro Medicine Prof Inc /ID# 55126
      • Toronto, Ontario, Canada, M3H 5Y8
        • Toronto Dermatology Centre /ID# 55127
    • Quebec
      • Drummondville, Quebec, Canada, J2B 5L4
        • Dr. Isabelle Delorme Inc. /ID# 57791
      • Montreal, Quebec, Canada, J7Z 3B8
        • Dre. Angelique Gagne-Henley /ID# 125204
      • Pierrefonds, Quebec, Canada, H8Z 1W5
        • Dr. Loukia-Maria Mitsos /ID# 124156
      • Verdun, Quebec, Canada, H4G 3E7
        • Dermatologie Sima Inc. /ID# 54922
      • Westmount, Quebec, Canada, H3Z 2S6
        • Dr. Beatrice Wang /ID# 63242
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 0W8
        • Royal Univ. Hosp, Saskatoon,CA /ID# 74613

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants receiving treatment for psoriasis with adalimumab (alone or in combination with topical agents) or, either a topical (new, not used before or being treated and not responding) or, a traditional systemic agent (not used before alone or in combination with topical agents).

Description

Inclusion Criteria:

  • Active moderate or severe plaque psoriasis according to the judgment of the treating physician.
  • The treating physician has decided to change the current treatment or add additional treatments for any reason including but not limited to inadequate response, intolerance, sub-optimal compliance or participant preference.

Exclusion Criteria:

  • Had currently participated in another prospective study with similar objectives.
  • Participant could not or would not sign informed consent.
  • Presence of other condition that, in the opinion of the treating physician, prohibits the participant from participating in the study or obscured the assessment of the treatment of plaque psoriasis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Topical/Traditional Systemic Agent
Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.
Adalimumab
Participants treated with adalimumab alone or in combination with topical agents.
Biological: Adalimumab
Adalimumab administered by subcutaneous injection.
Other Names:
  • Humira

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With a Physician Global Assessment (PGA) Score ≤1 at Month 6
Time Frame: Month 6

The Physician global assessment (PGA) score is an assessment by the investigator of the overall disease severity at the time of evaluation. The PGA uses a 6-point scale. The degree of overall lesion severity was evaluated using the following categories:

  • 0 (Clear): No evidence of scaling or plaque elevation; erythema may be present;
  • 1 (Minimal): scaling may be present, up to moderate erythema, minimal plaque elevation;
  • 2 (Mild): Fine scaling, up to moderate erythema, slight plaque elevation;
  • 3 (Moderate): Coarse scale dominates, moderate erythema, moderate plaque elevation;
  • 4 (Severe): Coarse non-tenacious scale dominates, severe erythema, marked plaque elevation;
  • 5 (Very Severe): Very coarse thick tenacious scale predominates, very severe erythema, severe plaque elevation.

A higher score indicates greater disease severity. Percentages based on the total number of intent to treat (ITT) participants who attended each visit.
Month 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Achieving PGA ≤ 1
Time Frame: Baseline, Month 3, Month 6, Month 12, Month 18, and Month 24

The PGA is an assessment by the investigator of the overall disease severity at the time of evaluation. The PGA uses a 6-point scale. The degree of overall lesion severity was evaluated using the following categories:

  • 0 (Clear): No evidence of scaling or plaque elevation; erythema may be present;
  • 1 (Minimal): scaling may be present, up to moderate erythema, minimal plaque elevation;
  • 2 (Mild): Fine scaling, up to moderate erythema, slight plaque elevation;
  • 3 (Moderate): Coarse scale dominates, moderate erythema, moderate plaque elevation;
  • 4 (Severe): Coarse non-tenacious scale dominates, severe erythema, marked plaque elevation;
  • 5 (Very Severe): Very coarse thick tenacious scale predominates, very severe erythema, severe plaque elevation.

A higher score indicates greater disease severity.
Baseline, Month 3, Month 6, Month 12, Month 18, and Month 24
PGA≤1: Percentage of Participants at Month 3
Time Frame: Month 3

The PGA is an assessment by the investigator of the overall disease severity at the time of evaluation. The PGA uses a 6-point scale. The degree of overall lesion severity was evaluated using the following categories:

  • 0 (Clear): No evidence of scaling or plaque elevation; erythema may be present;
  • 1 (Minimal): scaling may be present, up to moderate erythema, minimal plaque elevation;
  • 2 (Mild): Fine scaling, up to moderate erythema, slight plaque elevation;
  • 3 (Moderate): Coarse scale dominates, moderate erythema, moderate plaque elevation;
  • 4 (Severe): Coarse non-tenacious scale dominates, severe erythema, marked plaque elevation;
  • 5 (Very Severe): Very coarse thick tenacious scale predominates, very severe erythema, severe plaque elevation.

A higher score indicates greater disease severity. Percentages based on the total number of ITT participants who attended each visit.
Month 3
PGA≤1: Percentage of Participants at Month 12
Time Frame: Month 12

The PGA is an assessment by the investigator of the overall disease severity at the time of evaluation. The PGA uses a 6-point scale. The degree of overall lesion severity was evaluated using the following categories:

  • 0 (Clear): No evidence of scaling or plaque elevation; erythema may be present;
  • 1 (Minimal): scaling may be present, up to moderate erythema, minimal plaque elevation;
  • 2 (Mild): Fine scaling, up to moderate erythema, slight plaque elevation;
  • 3 (Moderate): Coarse scale dominates, moderate erythema, moderate plaque elevation;
  • 4 (Severe): Coarse non-tenacious scale dominates, severe erythema, marked plaque elevation;
  • 5 (Very Severe): Very coarse thick tenacious scale predominates, very severe erythema, severe plaque elevation.

A higher score indicates greater disease severity. Percentages based on the total number of ITT participants who attended each visit.
Month 12
PGA≤1: Percentage of Participants at Month 18
Time Frame: Month 18

The PGA is an assessment by the investigator of the overall disease severity at the time of evaluation. The PGA uses a 6-point scale. The degree of overall lesion severity was evaluated using the following categories:

  • 0 (Clear): No evidence of scaling or plaque elevation; erythema may be present;
  • 1 (Minimal): scaling may be present, up to moderate erythema, minimal plaque elevation;
  • 2 (Mild): Fine scaling, up to moderate erythema, slight plaque elevation;
  • 3 (Moderate): Coarse scale dominates, moderate erythema, moderate plaque elevation;
  • 4 (Severe): Coarse non-tenacious scale dominates, severe erythema, marked plaque elevation;
  • 5 (Very Severe): Very coarse thick tenacious scale predominates, very severe erythema, severe plaque elevation.

A higher score indicates greater disease severity. Percentages based on the total number of ITT participants who attended each visit.
Month 18
PGA≤1: Percentage of Participants at Month 24
Time Frame: Month 24

The PGA is an assessment by the investigator of the overall disease severity at the time of evaluation. The PGA uses a 6-point scale. The degree of overall lesion severity was evaluated using the following categories:

  • 0 (Clear): No evidence of scaling or plaque elevation; erythema may be present;
  • 1 (Minimal): scaling may be present, up to moderate erythema, minimal plaque elevation;
  • 2 (Mild): Fine scaling, up to moderate erythema, slight plaque elevation;
  • 3 (Moderate): Coarse scale dominates, moderate erythema, moderate plaque elevation;
  • 4 (Severe): Coarse non-tenacious scale dominates, severe erythema, marked plaque elevation;
  • 5 (Very Severe): Very coarse thick tenacious scale predominates, very severe erythema, severe plaque elevation.

A higher score indicates greater disease severity. Percentages based on the total number of ITT participants who attended each visit.
Month 24
Psoriasis and Arthritis Screening Questionnaire (PASQ) Total Score: Change From Baseline to Month 3
Time Frame: Baseline, Month 3
PASQ is an 11-item tool that ascertains self-reported presence of joint pain and swelling by the participant. The PASQ questionnaire consists of 10 questions for which a positive and negative response are assigned a score of 1 or 2, and 0, respectively. The maximum score is 10. In addition, participants were also asked to indicate on a diagram where they experienced joint swelling or pain. The diagram was scored 0, 1, 3, or 5, depending on the distribution of the participants' markings. The final composite score for the PASQ ranges from 0 to a maximum of 15. A decrease indicates improvement.
Baseline, Month 3
PASQ Total Score: Change From Baseline to Month 6
Time Frame: Baseline, Month 6
PASQ is an 11-item tool that ascertains self-reported presence of joint pain and swelling by the participant. The PASQ questionnaire consists of 10 questions for which a positive and negative response are assigned a score of 1 or 2, and 0, respectively. The maximum score is 10. In addition, participants were also asked to indicate on a diagram where they experienced joint swelling or pain. The diagram was scored 0, 1, 3, or 5, depending on the distribution of the participants' markings. The final composite score for the PASQ ranges from 0 to a maximum of 15. A decrease indicates improvement.
Baseline, Month 6
PASQ Total Score: Change From Baseline to Month 12
Time Frame: Baseline, Month 12
PASQ is an 11-item tool that ascertains self-reported presence of joint pain and swelling by the participant. The PASQ questionnaire consists of 10 questions for which a positive and negative response are assigned a score of 1 or 2, and 0, respectively. The maximum score is 10. In addition, participants were also asked to indicate on a diagram where they experienced joint swelling or pain. The diagram was scored 0, 1, 3, or 5, depending on the distribution of the participants' markings. The final composite score for the PASQ ranges from 0 to a maximum of 15. A decrease indicates improvement.
Baseline, Month 12
PASQ Total Score: Change From Baseline to Month 18
Time Frame: Baseline, Month 18
PASQ is an 11-item tool that ascertains self-reported presence of joint pain and swelling by the participant. The PASQ questionnaire consists of 10 questions for which a positive and negative response are assigned a score of 1 or 2, and 0, respectively. The maximum score is 10. In addition, participants were also asked to indicate on a diagram where they experienced joint swelling or pain. The diagram was scored 0, 1, 3, or 5, depending on the distribution of the participants' markings. The final composite score for the PASQ ranges from 0 to a maximum of 15. A decrease indicates improvement.
Baseline, Month 18
PASQ Total Score: Change From Baseline to Month 24
Time Frame: Baseline, Month 24
PASQ is an 11-item tool that ascertains self-reported presence of joint pain and swelling by the participant. The PASQ questionnaire consists of 10 questions for which a positive and negative response are assigned a score of 1 or 2, and 0, respectively. The maximum score is 10. In addition, participants were also asked to indicate on a diagram where they experienced joint swelling or pain. The diagram was scored 0, 1, 3, or 5, depending on the distribution of the participants' markings. The final composite score for the PASQ ranges from 0 to a maximum of 15. A decrease indicates improvement.
Baseline, Month 24
Body Surface Area of Psoriasis Involvement: Change From Baseline to Month 6
Time Frame: Baseline, Month 6
The Body Surface Area (BSA) is an indicator of disease severity and the affected area is expressed as a percentage of the total body surface area.The BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement.
Baseline, Month 6
BSA of Psoriasis Involvement: Change From Baseline to Month 12
Time Frame: Baseline, Month 12
The BSA is an indicator of disease severity and the affected area is expressed as a percentage of the total body surface area.The BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement.
Baseline, Month 12
BSA of Psoriasis Involvement: Change From Baseline to Month 18
Time Frame: Baseline, Month 18
The BSA is an indicator of disease severity and the affected area is expressed as a percentage of the total body surface area.The BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement.
Baseline, Month 18
BSA of Psoriasis Involvement: Change From Baseline to Month 24
Time Frame: Baseline, Month 24
The BSA is an indicator of disease severity and the affected area is expressed as a percentage of the total body surface area.The BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement.
Baseline, Month 24
Patient Global Assessment (PtGA) of Disease Activity Based on a Visual Analog Scale (VAS): Change From Baseline to Month 3
Time Frame: Baseline, Month 3
Patient Global Assessment of disease activity (PtGA) was assessed using a visual analog scale (VAS) where 0 indicates doing very well with respect to arthritis and/or skin psoriasis and a value of 100 indicates doing very poorly.
Baseline, Month 3
PtGA of Disease Activity Based on a VAS: Change From Baseline to Month 6
Time Frame: Baseline, Month 6
PtGA of disease activity was assessed using a VAS where 0 indicates doing very well with respect to arthritis and/or skin psoriasis and a value of 100 indicates doing very poorly.
Baseline, Month 6
PtGA of Disease Activity Based on a VAS: Change From Baseline to Month 12
Time Frame: Baseline, Month 12
PtGA of disease activity was assessed using a VAS where 0 indicates doing very well with respect to arthritis and/or skin psoriasis and a value of 100 indicates doing very poorly.
Baseline, Month 12
PtGA of Disease Activity Based on a VAS: Change From Baseline to Month 18
Time Frame: Baseline, Month 18
PtGA of disease activity was assessed using a VAS where 0 indicates doing very well with respect to arthritis and/or skin psoriasis and a value of 100 indicates doing very poorly.
Baseline, Month 18
PtGA of Disease Activity Based on a VAS: Change From Baseline to Month 24
Time Frame: Baseline, Month 24
PtGA of disease activity was assessed using a VAS where 0 indicates doing very well with respect to arthritis and/or skin psoriasis and a value of 100 indicates doing very poorly.
Baseline, Month 24
Dermatology Quality of Life Index (DLQI) Total Score: Change From Baseline to Month 3
Time Frame: Baseline, Month 3
The Dermatology Quality of Life Index (DLQI) is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on participant's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on participant's life. The higher the score, the more the participant's quality of life is impaired. A 5-point change from baseline is considered a clinically important difference.
Baseline, Month 3
DLQI Total Score: Change From Baseline to Month 6
Time Frame: Baseline, Month 6
The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on participant's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on participant's life. The higher the score, the more the participant's quality of life is impaired. A 5-point change from baseline is considered a clinically important difference.
Baseline, Month 6
DLQI Total Score: Change From Baseline to Month 12
Time Frame: Baseline, Month 12
The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on participant's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on participant's life. The higher the score, the more the participant's quality of life is impaired. A 5-point change from baseline is considered a clinically important difference.
Baseline, Month 12
DLQI Total Score: Change From Baseline to Month 18
Time Frame: Baseline, Month 18
The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on participant's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on participant's life. The higher the score, the more the participant's quality of life is impaired. A 5-point change from baseline is considered a clinically important difference.
Baseline, Month 18
DLQI Total Score: Change From Baseline to Month 24
Time Frame: Baseline, Month 24
The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on participant's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on participant's life. The higher the score, the more the participant's quality of life is impaired. A 5-point change from baseline is considered a clinically important difference.
Baseline, Month 24
Time to Achieving DLQI ≤1
Time Frame: Baseline, Month 3, Month 6, Month 12, Month 18, and Month 24
The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on participant's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on participant's life. The higher the score, the more the participant's quality of life is impaired. A 5-point change from baseline is considered a clinically important difference.
Baseline, Month 3, Month 6, Month 12, Month 18, and Month 24
DLQI ≤1: Percentage of Participants at Month 3
Time Frame: Month 3
The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on participant's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on participant's life. The higher the score, the more the participant's quality of life is impaired. A 5-point change from baseline is considered a clinically important difference. Percentage based on the total number of ITT participants who attended each visit.
Month 3
DLQI ≤1: Percentage of Participants at Month 6
Time Frame: Month 6
The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on participant's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on participant's life. The higher the score, the more the participant's quality of life is impaired. A 5-point change from baseline is considered a clinically important difference. Percentage based on the total number of ITT participants who attended each visit.
Month 6
DLQI ≤1: Percentage of Participants at Month 12
Time Frame: Month 12
The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on participant's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on participant's life. The higher the score, the more the participant's quality of life is impaired. A 5-point change from baseline is considered a clinically important difference. Percentage based on the total number of ITT participants who attended each visit.
Month 12
DLQI ≤1: Percentage of Participants at Month 18
Time Frame: Month 18
The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on participant's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on participant's life. The higher the score, the more the participant's quality of life is impaired. A 5-point change from baseline is considered a clinically important difference. Percentage based on the total number of ITT participants who attended each visit.
Month 18
DLQI ≤1: Percentage of Participants at Month 24
Time Frame: Month 24
The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on participant's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on participant's life. The higher the score, the more the participant's quality of life is impaired. A 5-point change from baseline is considered a clinically important difference. Percentage based on the total number of ITT participants who attended each visit.
Month 24
Beck Depression Inventory II (BDI-II): Change From Baseline to Month 6
Time Frame: Baseline, Month 6

The Beck Depression inventory assesses the presence and severity of depression and responsiveness to treatment. It consists of 21 items converging on 2 scales measuring somatic and affective components of depression. The questions assess hopelessness and irritability, cognition such as guilt or feelings of being punished, as well as physical symptoms such as fatigue, weight loss, and loss of interest in sex.

The total score ranges from a minimum of 0 to a maximum of 63 with the following suggested score interpretations: minimal range = 0-13, mild depression = 14-19, moderate depression = 20-28, and severe depression = 29-63.

The higher the score, the greater the severity of the depression.
Baseline, Month 6
BDI-II: Change From Baseline to Month 12
Time Frame: Baseline, Month 12

The Beck Depression inventory assesses the presence and severity of depression and responsiveness to treatment. It consists of 21 items converging on 2 scales measuring somatic and affective components of depression. The questions assess hopelessness and irritability, cognition such as guilt or feelings of being punished, as well as physical symptoms such as fatigue, weight loss, and loss of interest in sex.

The total score ranges from a minimum of 0 to a maximum of 63 with the following suggested score interpretations: minimal range = 0-13, mild depression = 14-19, moderate depression = 20-28, and severe depression = 29-63.

The higher the score, the greater the severity of the depression.
Baseline, Month 12
BDI-II: Change From Baseline to Month 24
Time Frame: Baseline, Month 24

The Beck Depression inventory assesses the presence and severity of depression and responsiveness to treatment. It consists of 21 items converging on 2 scales measuring somatic and affective components of depression. The questions assess hopelessness and irritability, cognition such as guilt or feelings of being punished, as well as physical symptoms such as fatigue, weight loss, and loss of interest in sex.

The total score ranges from a minimum of 0 to a maximum of 63 with the following suggested score interpretations: minimal range = 0-13, mild depression = 14-19, moderate depression = 20-28, and severe depression = 29-63.

The higher the score, the greater the severity of the depression.
Baseline, Month 24
Medical Outcomes Study Short Form-12 Health Status Survey (SF-12) Mental Component Summary (MCS) Score: Change From Baseline to Month 6
Time Frame: Baseline, Month 6
The Medical Outcomes Study Short Form 12 (SF-12) questionnaire is a shortened form (12 items) of the SF-36 Health Survey generic quality of life questionnaire that assesses eight health concepts: 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality (energy and fatigue); 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health (psychological distress and well-being). Items 5-8 comprise the mental component of the SF-12. Scores on each item were summed and averaged (MCS Score; range = 0-100); a positive change from Baseline indicates improvement.
Baseline, Month 6
SF-12 MCS Score: Change From Baseline to Month 12
Time Frame: Baseline, Month 12
The SF-12 questionnaire is a shortened form (12 items) of the SF-36 Health Survey generic quality of life questionnaire that assesses eight health concepts: 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality (energy and fatigue); 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health (psychological distress and well-being). Items 5-8 comprise the mental component of the SF-12. Scores on each item were summed and averaged (MCS Score; range = 0-100); a positive change from Baseline indicates improvement.
Baseline, Month 12
SF-12 MCS Score: Change From Baseline to Month 24
Time Frame: Baseline, Month 24
The SF-12 questionnaire is a shortened form (12 items) of the SF-36 Health Survey generic quality of life questionnaire that assesses eight health concepts: 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality (energy and fatigue); 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health (psychological distress and well-being). Items 5-8 comprise the mental component of the SF-12. Scores on each item were summed and averaged (MCS Score; range = 0-100); a positive change from Baseline indicates improvement.
Baseline, Month 24
SF-12 Physical Component Summary (PCS) Score: Change From Baseline to Month 6
Time Frame: Baseline, Month 6
The SF-12 questionnaire is a shortened form (12 items) of the SF-36 Health Survey generic quality of life questionnaire that assesses eight health concepts: 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality (energy and fatigue); 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health (psychological distress and well-being). Items 1-4 comprise the physical component of the SF-12. Scores on each item were summed and averaged (PCS Score; range = 0-100); a positive change from Baseline indicates improvement.
Baseline, Month 6
SF-12 PCS Score: Change From Baseline to Month 12
Time Frame: Baseline, Month 12
The SF-12 questionnaire is a shortened form (12 items) of the SF-36 Health Survey generic quality of life questionnaire that assesses eight health concepts: 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality (energy and fatigue); 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health (psychological distress and well-being). Items 1-4 comprise the physical component of the SF-12. Scores on each item were summed and averaged (PCS Score; range = 0-100); a positive change from Baseline indicates improvement.
Baseline, Month 12
SF-12 PCS Score: Change From Baseline to Month 24
Time Frame: Baseline, Month 24
The SF-12 questionnaire is a shortened form (12 items) of the SF-36 Health Survey generic quality of life questionnaire that assesses eight health concepts: 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality (energy and fatigue); 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health (psychological distress and well-being). Items 1-4 comprise the physical component of the SF-12. Scores on each item were summed and averaged (PCS Score; range = 0-100); a positive change from Baseline indicates improvement.
Baseline, Month 24
Work Limitation Questionnaire (WLQ) Total Score: Change From Baseline to Month 6
Time Frame: Baseline, Month 6

The Work Limitation Questionnaire (WLQ) is a self-administered questionnaire comprised of 25 questions.

The WLQ evaluates the participant's overall ability to work in the last two weeks. It comprises 25 questions each with a range of 100% ('all of the time') to 0% ('none of the time') where 6 represents non-applicability to the patient's line of work.

The WLQ Productivity Loss Score indicates the percentage decrement in work output due to health problems. The WLQ Productivity Loss score is based on a weighted sum of the scores from the 4 WLQ scales (Time, Physical, Mental-Interpersonal, and Output). The resulting score (known as the WLQ Index) is in the form of the natural log of work productivity. The final step needed to generate the WLQ Productivity Loss Score is to convert the WLQ Index score to a percentage. The higher the score, the greater the work limitation.
Baseline, Month 6
WLQ Total Score: Change From Baseline to Month 12
Time Frame: Baseline, Month 12

The WLQ is a self-administered questionnaire comprised of 25 questions. The WLQ evaluates the participant's overall ability to work in the last two weeks. It comprises 25 questions each with a range of 100% ('all of the time') to 0% ('none of the time') where 6 represents non-applicability to the patient's line of work.

The WLQ Productivity Loss Score indicates the percentage decrement in work output due to health problems. The WLQ Productivity Loss score is based on a weighted sum of the scores from the 4 WLQ scales (Time, Physical, Mental-Interpersonal, and Output). The resulting score (known as the WLQ Index) is in the form of the natural log of work productivity. The final step needed to generate the WLQ Productivity Loss Score is to convert the WLQ Index score to a percentage. The higher the score, the greater the work limitation.
Baseline, Month 12
WLQ Total Score: Change From Baseline to Month 24
Time Frame: Baseline, Month 24

The WLQ is a self-administered questionnaire comprised of 25 questions. The WLQ evaluates the participant's overall ability to work in the last two weeks. It comprises 25 questions each with a range of 100% ('all of the time') to 0% ('none of the time') where 6 represents non-applicability to the patient's line of work.

The WLQ Productivity Loss Score indicates the percentage decrement in work output due to health problems. The WLQ Productivity Loss score is based on a weighted sum of the scores from the 4 WLQ scales (Time, Physical, Mental-Interpersonal, and Output). The resulting score (known as the WLQ Index) is in the form of the natural log of work productivity. The final step needed to generate the WLQ Productivity Loss Score is to convert the WLQ Index score to a percentage. The higher the score, the greater the work limitation.
Baseline, Month 24
WLQ Productivity Loss Score: Change From Baseline to Month 6
Time Frame: Baseline, Month 6

The WLQ is a self-administered questionnaire comprised of 25 questions. The WLQ evaluates the participant's overall ability to work in the last two weeks. It comprises 25 questions each with a range of 100% ('all of the time') to 0% ('none of the time') where 6 represents non-applicability to the patient's line of work.

The WLQ Productivity Loss Score indicates the percentage decrement in work output due to health problems. The WLQ Productivity Loss score is based on a weighted sum of the scores from the 4 WLQ scales (Time, Physical, Mental-Interpersonal, and Output). The resulting score (known as the WLQ Index) is in the form of the natural log of work productivity. The final step needed to generate the WLQ Productivity Loss Score is to convert the WLQ Index score to a percentage. The higher the score, the greater the work limitation.
Baseline, Month 6
WLQ Productivity Loss Score: Change From Baseline to Month 12
Time Frame: Baseline, Month 12

The WLQ is a self-administered questionnaire comprised of 25 questions. The WLQ evaluates the participant's overall ability to work in the last two weeks. It comprises 25 questions each with a range of 100% ('all of the time') to 0% ('none of the time') where 6 represents non-applicability to the patient's line of work.

The WLQ Productivity Loss Score indicates the percentage decrement in work output due to health problems. The WLQ Productivity Loss score is based on a weighted sum of the scores from the 4 WLQ scales (Time, Physical, Mental-Interpersonal, and Output). The resulting score (known as the WLQ Index) is in the form of the natural log of work productivity. The final step needed to generate the WLQ Productivity Loss Score is to convert the WLQ Index score to a percentage. The higher the score, the greater the work limitation.
Baseline, Month 12
WLQ Productivity Loss Score: Change From Baseline to Month 24
Time Frame: Baseline, Month 24

The WLQ is a self-administered questionnaire comprised of 25 questions. The WLQ evaluates the participant's overall ability to work in the last two weeks. It comprises 25 questions each with a range of 100% ('all of the time') to 0% ('none of the time') where 6 represents non-applicability to the patient's line of work.

The WLQ Productivity Loss Score indicates the percentage decrement in work output due to health problems. The WLQ Productivity Loss score is based on a weighted sum of the scores from the 4 WLQ scales (Time, Physical, Mental-Interpersonal, and Output). The resulting score (known as the WLQ Index) is in the form of the natural log of work productivity. The final step needed to generate the WLQ Productivity Loss Score is to convert the WLQ Index score to a percentage. The higher the score, the greater the work limitation.
Baseline, Month 24
Healthcare Resource Utilization (HCRU): Number of Participants With Insurance for Prescription Medication at Month 6
Time Frame: Month 6
Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.
Month 6
HCRU: Number of Participants With Insurance for Prescription Medication at Month 12
Time Frame: Month 12
Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.
Month 12
HCRU: Number of Participants With Insurance for Prescription Medication at Month 24
Time Frame: Month 24
Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.
Month 24
HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 6
Time Frame: Month 6
Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.
Month 6
HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 12
Time Frame: Month 12
Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.
Month 12
HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 24
Time Frame: Month 24
Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.
Month 24
HCRU: Number of Participants Seeking Health Care in the Past 4 Weeks for Ankylosing Spondylitis (AS) at Month 6
Time Frame: Month 6
Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.
Month 6
HCRU: Number of Participants Seeking Health Care in the Past 4 Weeks for AS at Month 12
Time Frame: Month 12
Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.
Month 12
HCRU: Number of Participants Seeking Health Care in the Past 4 Weeks for AS at Month 24
Time Frame: Month 24
Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.
Month 24
HCRU: Number of Participants Making Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 6
Time Frame: Month 6
Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.
Month 6
HCRU: Number of Participants Making Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 12
Time Frame: Month 12
Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.
Month 12
HCRU: Number of Participants Making Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 24
Time Frame: Month 24
Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.
Month 24
HCRU: Number of Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 6
Time Frame: Month 6
Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.
Month 6
HCRU: Number of Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 12
Time Frame: Month 12
Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.
Month 12
HCRU: Number of Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 24
Time Frame: Month 24
Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.
Month 24
HCRU: Number of Participants Making Visits to Another Physician at Month 6
Time Frame: Month 6
Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.
Month 6
HCRU: Number of Participants Making Visits to Another Physician at Month 12
Time Frame: Month 12
Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.
Month 12
HCRU: Number of Participants Making Visits to Another Physician at Month 24
Time Frame: Month 24
Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.
Month 24
HCRU: Number of Visits to Another Physician at Month 6
Time Frame: Month 6
Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.
Month 6
HCRU: Number of Visits to Another Physician at Month 12
Time Frame: Month 12
Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.
Month 12
HCRU: Number of Visits to Another Physician at Month 24
Time Frame: Month 24
Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.
Month 24
HCRU: Number of Participants Making Visits to a Healthcare Professional at Month 6
Time Frame: Month 6
Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.
Month 6
HCRU: Number of Participants Making Visits to a Healthcare Professional at Month 12
Time Frame: Month 12
Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.
Month 12
HCRU: Number of Participants Making Visits to a Healthcare Professional at Month 24
Time Frame: Month 24
Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.
Month 24
HCRU: Number of Visits to A Healthcare Professional at Month 6
Time Frame: Month 6
Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.
Month 6
HCRU: Number of Visits to A Healthcare Professional at Month 12
Time Frame: Month 12
Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.
Month 12
HCRU: Number of Visits to A Healthcare Professional at Month 24
Time Frame: Month 24
Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.
Month 24
HCRU: Number of Participants Making Visits to a Hospital Emergency Room at Month 6
Time Frame: Month 6
Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.
Month 6
HCRU: Number of Participants Making Visits to a Hospital Emergency Room at Month 12
Time Frame: Month 12
Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.
Month 12
HCRU: Number of Participants Making Visits to a Hospital Emergency Room at Month 24
Time Frame: Month 24
Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.
Month 24
HCRU: Number of Visits to a Hospital Emergency Room at Month 6
Time Frame: Month 6
Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.
Month 6
HCRU: Number of Visits to a Hospital Emergency Room at Month 12
Time Frame: Month 12
Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.
Month 12
HCRU: Number of Visits to a Hospital Emergency Room at Month 24
Time Frame: Month 24
Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.
Month 24
HCRU: Number of Participants Making Use of an Ambulance Service at Month 6
Time Frame: Month 6
Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.
Month 6
HCRU: Number of Participants Making Use of an Ambulance Service at Month 12
Time Frame: Month 12
Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.
Month 12
HCRU: Number of Participants Making Use of an Ambulance Service at Month 24
Time Frame: Month 24
Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.
Month 24
HCRU: Number of Participants Making Complementary/Alternate Therapy Visits at Month 6
Time Frame: Month 6
Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.
Month 6
HCRU: Number of Participants Making Complementary/Alternate Therapy Visits at Month 12
Time Frame: Month 12
Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.
Month 12
HCRU: Number of Participants Making Complementary/Alternate Therapy Visits at Month 24
Time Frame: Month 24
Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.
Month 24
HCRU: Number of Complementary/Alternate Therapy Visits at Month 6
Time Frame: Month 6
Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.
Month 6
HCRU: Number of Complementary/Alternate Therapy Visits at Month 12
Time Frame: Month 12
Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.
Month 12
HCRU: Number of Complementary/Alternate Therapy Visits at Month 24
Time Frame: Month 24
Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.
Month 24
HCRU: Number of Participants Hospitalized in the Past 4 Weeks at Month 6
Time Frame: Month 6
Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.
Month 6
HCRU: Number of Participants Hospitalized in the Past 4 Weeks at Month 12
Time Frame: Month 12
Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.
Month 12
HCRU: Number of Participants Hospitalized in the Past 4 Weeks at Month 24
Time Frame: Month 24
Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.
Month 24
HCRU: Length of Hospital Stay for Those Participants Hospitalized at Month 6
Time Frame: Month 6
Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.
Month 6
HCRU: Length of Hospital Stay for Those Participants Hospitalized at Month 12
Time Frame: Month 12
Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.
Month 12
HCRU: Length of Hospital Stay for Those Participants Hospitalized at Month 24
Time Frame: Month 24
Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.
Month 24
HCRU: Number of Participants Admitted to the Intensive Care Unit (ICU) in the Past 4 Weeks at Month 6
Time Frame: Month 6
Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.
Month 6
HCRU: Number of Participants Admitted to the ICU in the Past 4 Weeks at Month 12
Time Frame: Month 12
Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.
Month 12
HCRU: Number of Participants Admitted to the ICU in the Past 4 Weeks at Month 24
Time Frame: Month 24
Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.
Month 24
HCRU: Cost of Payment for Over the Counter Medications at Month 6
Time Frame: Month 6
Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.
Month 6
HCRU: Cost of Payment for Over the Counter Medications at Month 12
Time Frame: Month 12
Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.
Month 12
HCRU: Cost of Payment for Over the Counter Medications at Month 24
Time Frame: Month 24
Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.
Month 24
HCRU: Cost of Payments to Healthcare Professionals at Month 6
Time Frame: Month 6
Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.
Month 6
HCRU: Cost of Payments to Healthcare Professionals at Month 12
Time Frame: Month 12
Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.
Month 12
HCRU: Cost of Payments to Healthcare Professionals at Month 24
Time Frame: Month 24
Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.
Month 24
HCRU: Cost of Payments for Medical Procedures or Laboratory Tests at Month 6
Time Frame: Month 6
Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.
Month 6
HCRU: Cost of Payments for Medical Procedures or Laboratory Tests at Month 12
Time Frame: Month 12
Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.
Month 12
HCRU: Cost of Payments for Medical Procedures or Laboratory Tests at Month 24
Time Frame: Month 24
Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.
Month 24
HCRU: Cost of Payments for Medical Devices at Month 6
Time Frame: Month 6
Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.
Month 6
HCRU: Cost of Payments for Medical Devices at Month 12
Time Frame: Month 12
Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.
Month 12
HCRU: Cost of Payments for Medical Devices at Month 24
Time Frame: Month 24
Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.
Month 24
HCRU: Cost of Payments for Health Care or Extra Help at Home at Month 6
Time Frame: Month 6
Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.
Month 6
HCRU: Cost of Payments for Health Care or Extra Help at Home at Month 12
Time Frame: Month 12
Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.
Month 12
HCRU: Cost of Payments for Health Care or Extra Help at Home at Month 24
Time Frame: Month 24
Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.
Month 24
HCRU: Cost of Payments for Transportation at Month 6
Time Frame: Month 6
Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.
Month 6
HCRU: Cost of Payments for Transportation at Month 12
Time Frame: Month 12
Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.
Month 12
HCRU: Cost of Payments for Transportation at Month 24
Time Frame: Month 24
Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.
Month 24
Topical Treatment Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 3
Time Frame: Month 3
Psoriasis treatment compliance by the participant was assessed by a self-administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician. The questions included the number missed since the last visit of: applications for topical medication; phototherapy sessions; doses of traditional systemic agents; and adalimumab injections.
Month 3
Topical Treatment Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 6
Time Frame: Month 6
Psoriasis treatment compliance by the participant was assessed by a self-administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician. The questions included the number missed since the last visit of: applications for topical medication; phototherapy sessions; doses of traditional systemic agents; and adalimumab injections.
Month 6
Topical Treatment Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 12
Time Frame: Month 12
Psoriasis treatment compliance by the participant was assessed by a self-administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician. The questions included the number missed since the last visit of: applications for topical medication; phototherapy sessions; doses of traditional systemic agents; and adalimumab injections.
Month 12
Topical Treatment Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 18
Time Frame: Month 18
Psoriasis treatment compliance by the participant was assessed by a self-administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician. The questions included the number missed since the last visit of: applications for topical medication; phototherapy sessions; doses of traditional systemic agents; and adalimumab injections.
Month 18
Topical Treatment Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 24
Time Frame: Month 24
Psoriasis treatment compliance by the participant was assessed by a self-administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician. The questions included the number missed since the last visit of: applications for topical medication; phototherapy sessions; doses of traditional systemic agents; and adalimumab injections.
Month 24
Phototherapy Session Patient Reported Treatment Compliance: Number of Missed Sessions Since Last Visit Assessed at Month 3
Time Frame: Month 3
Phototherapy sessions for psoriasis compliance by the participant was assessed by a self administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24 as part of the psoriasis treatment compliance questionnaire. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician.
Month 3
Phototherapy Session Patient Reported Treatment Compliance: Number of Missed Sessions Since Last Visit Assessed at Month 6
Time Frame: Month 6
Phototherapy sessions for psoriasis compliance by the participant was assessed by a self administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24 as part of the psoriasis treatment compliance questionnaire. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician.
Month 6
Phototherapy Session Patient Reported Treatment Compliance: Number of Missed Sessions Since Last Visit Assessed at Month 12
Time Frame: Month 12
Phototherapy sessions for psoriasis compliance by the participant was assessed by a self administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24 as part of the psoriasis treatment compliance questionnaire. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician.
Month 12
Phototherapy Session Patient Reported Treatment Compliance: Number of Missed Sessions Since Last Visit Assessed at Month 18
Time Frame: Month 18
Phototherapy sessions for psoriasis compliance by the participant was assessed by a self administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24 as part of the psoriasis treatment compliance questionnaire. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician.
Month 18
Phototherapy Session Patient Reported Treatment Compliance: Number of Missed Sessions Since Last Visit Assessed at Month 24
Time Frame: Month 24
Phototherapy sessions for psoriasis compliance by the participant was assessed by a self administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24 as part of the psoriasis treatment compliance questionnaire. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician.
Month 24
Traditional Systemic Agent Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 3
Time Frame: Month 3
Psoriasis treatment compliance by the participant was assessed by a self-administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician. The questions included the number missed since the last visit of: applications for topical medication; phototherapy sessions; doses of traditional systemic agents; and adalimumab injections.
Month 3
Traditional Systemic Agent Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 6
Time Frame: Month 6
Psoriasis treatment compliance by the participant was assessed by a self-administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician. The questions included the number missed since the last visit of: applications for topical medication; phototherapy sessions; doses of traditional systemic agents; and adalimumab injections.
Month 6
Traditional Systemic Agent Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 12
Time Frame: Month 12
Psoriasis treatment compliance by the participant was assessed by a self-administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician. The questions included the number missed since the last visit of: applications for topical medication; phototherapy sessions; doses of traditional systemic agents; and adalimumab injections.
Month 12
Traditional Systemic Agent Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 18
Time Frame: Month 18
Psoriasis treatment compliance by the participant was assessed by a self-administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician. The questions included the number missed since the last visit of: applications for topical medication; phototherapy sessions; doses of traditional systemic agents; and adalimumab injections.
Month 18
Traditional Systemic Agent Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 24
Time Frame: Month 24
Psoriasis treatment compliance by the participant was assessed by a self-administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician. The questions included the number missed since the last visit of: applications for topical medication; phototherapy sessions; doses of traditional systemic agents; and adalimumab injections.
Month 24
Adalimumab Injection Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 3
Time Frame: Month 3
Psoriasis treatment compliance by the participant was assessed by a self-administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician. The questions included the number missed since the last visit of: applications for topical medication; phototherapy sessions; doses of traditional systemic agents; and adalimumab injections.
Month 3
Adalimumab Injection Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 6
Time Frame: Month 6
Psoriasis treatment compliance by the participant was assessed by a self-administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician. The questions included the number missed since the last visit of: applications for topical medication; phototherapy sessions; doses of traditional systemic agents; and adalimumab injections.
Month 6
Adalimumab Injection Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 12
Time Frame: Month 12
Psoriasis treatment compliance by the participant was assessed by a self-administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician. The questions included the number missed since the last visit of: applications for topical medication; phototherapy sessions; doses of traditional systemic agents; and adalimumab injections.
Month 12
Adalimumab Injection Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 18
Time Frame: Month 18
Psoriasis treatment compliance by the participant was assessed by a self-administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician. The questions included the number missed since the last visit of: applications for topical medication; phototherapy sessions; doses of traditional systemic agents; and adalimumab injections.
Month 18
Adalimumab Injection Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 24
Time Frame: Month 24
Psoriasis treatment compliance by the participant was assessed by a self-administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician. The questions included the number missed since the last visit of: applications for topical medication; phototherapy sessions; doses of traditional systemic agents; and adalimumab injections.
Month 24
Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 3
Time Frame: Month 3
Changes in medical history were assessed by the treating physician since the last visit at Month 3, 6, 12, 18, and 24. A global assessment of physical changes per standard of care was recorded for each participant as "yes", "no", "not done" or missing.
Month 3
Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 6
Time Frame: Month 6
Changes in medical history were assessed by the treating physician since the last visit at Month 3, 6, 12, 18, and 24. A global assessment of physical changes per standard of care was recorded for each participant as "yes", "no", "not done" or missing.
Month 6
Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 12
Time Frame: Month 12
Changes in medical history were assessed by the treating physician since the last visit at Month 3, 6, 12, 18, and 24. A global assessment of physical changes per standard of care was recorded for each participant as "yes", "no", "not done" or missing.
Month 12
Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 18
Time Frame: Month 18
Changes in medical history were assessed by the treating physician since the last visit at Month 3, 6, 12, 18, and 24. A global assessment of physical changes per standard of care was recorded for each participant as "yes", "no", "not done" or missing.
Month 18
Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 24
Time Frame: Month 24
Changes in medical history were assessed by the treating physician since the last visit at Month 3, 6, 12, 18, and 24. A global assessment of physical changes per standard of care was recorded for each participant as "yes", "no", "not done" or missing.
Month 24
Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 3
Time Frame: Month 3
Change in concomitant medication use by the participant was defined as any treatment, whether prescription or over the counter, used by the participant for psoriasis before and during the study. Details were recorded in the Case Report Form by the investigator and included dose, frequency, and duration of treatment and route. Change was assessed by treating physician per standard of care at Month 3, 6, 12, 18, and 24. A global assessment of change was recorded for each participant as "yes", "no", "not done" or missing.
Month 3
Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 6
Time Frame: Month 6
Change in concomitant medication use by the participant was defined as any treatment, whether prescription or over the counter, used by the participant for psoriasis before and during the study. Details were recorded in the Case Report Form by the investigator and included dose, frequency, and duration of treatment and route. Change was assessed by treating physician per standard of care at Month 3, 6, 12, 18, and 24. A global assessment of change was recorded for each participant as "yes", "no", "not done" or missing.
Month 6
Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 12
Time Frame: Month 12
Change in concomitant medication use by the participant was defined as any treatment, whether prescription or over the counter, used by the participant for psoriasis before and during the study. Details were recorded in the Case Report Form by the investigator and included dose, frequency, and duration of treatment and route. Change was assessed by treating physician per standard of care at Month 3, 6, 12, 18, and 24. A global assessment of change was recorded for each participant as "yes", "no", "not done" or missing.
Month 12
Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 18
Time Frame: Month 18
Change in concomitant medication use by the participant was defined as any treatment, whether prescription or over the counter, used by the participant for psoriasis before and during the study. Details were recorded in the Case Report Form by the investigator and included dose, frequency, and duration of treatment and route. Change was assessed by treating physician per standard of care at Month 3, 6, 12, 18, and 24. A global assessment of change was recorded for each participant as "yes", "no", "not done" or missing.
Month 18
Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 24
Time Frame: Month 24
Change in concomitant medication use by the participant was defined as any treatment, whether prescription or over the counter, used by the participant for psoriasis before and during the study. Details were recorded in the Case Report Form by the investigator and included dose, frequency, and duration of treatment and route. Change was assessed by treating physician per standard of care at Month 3, 6, 12, 18, and 24. A global assessment of change was recorded for each participant as "yes", "no", "not done" or missing.
Month 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie (prior sponsor, Abbott)

Collaborators

Cato Research
JSS Medical Research Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 16, 2011

Primary Completion (Actual)

June 29, 2018

Study Completion (Actual)

June 29, 2018

Study Registration Dates

First Submitted

July 1, 2011

First Submitted That Met QC Criteria

July 1, 2011

First Posted (Estimate)

July 6, 2011

Study Record Updates

Last Update Posted (Actual)

December 5, 2019

Last Update Submitted That Met QC Criteria

November 18, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P12-678

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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