- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01383421
Observational Study to Explore the Effectiveness of Adalimumab Treatment in Conjunction With Utilization of a Patient Support Program (PSP) (PASSION)
A Post-Marketing Observational Study (PMOS) to Determine the Effectiveness and Patient Satisfaction With Adalimumab Treatment in Patients With Rheumatoid Arthritis (PASSION Study)
Study Overview
Status
Conditions
Detailed Description
The main objectives of the study are to examine the effectiveness of adalimumab treatment with respect to PSPs by means of Health Assessment Questionnaire Disability Index (HAQ-DI), Disease Activity Score (DAS28) results, and European League Against Rheumatism (EULAR) response criteria, as well as to evaluate the contribution of PSP to disease control, treatment continuation over time, participant's satisfaction, and PSP utilization.
The primary endpoint is the percentage of participants achieving a minimal clinically important difference (MCID) in HAQ-DI at Week 78. (MCID is improvement of at least 0.22 in HAQ-DI compared to Baseline). Secondary endpoints include the percentage of participants achieving MCID in HAQ-DI at Weeks 12, 24, 36, 52, 64 and other effectiveness parameters, including: changes in DAS28, Simplified Disease Activity Index (SDAI), Clinical Disease Activity Index (CDAI), ACR 20/50/70 and EULAR moderate and good responses. Other secondary endpoints include health outcomes assessments including HAQ-DI, Work Productivity and Activity Impairment (WPAI), Compliance Questionnaire Rheumatology (CQR), and Treatment Satisfaction Questionnaire for Medication (TSQM) scores, expectation regarding PSP and health management via Patient Activation Measure (PAM-13), change in participant perceptions as measured by the Beliefs about Medicines Questionnaire (BMQ), and satisfaction with PSP as measured by PSP satisfaction assessment.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Male or female aged at least 18 years that has been newly prescribed adalimumab therapy according to the local product label, with the first dose corresponding to the Enrollment/Baseline visit.
- Patient with a diagnosis of moderate to severe RA, who has had insufficient response to one or more disease-modifying antirheumatic drugs (DMARDs), and has a prescription of adalimumab according to the local regulations.
- Patients should be evaluated for tuberculosis (TB) exposure/risk factors for active and latent TB (per local requirements and according to the local product label).
- Patients must be able and willing to provide written authorization to disclose and use personal health information (and informed consent where applicable) and comply with the requirements of this study protocol as well as agree to data being collected and provided to AbbVie.
Exclusion Criteria:
- Patients should not be enrolled if they cannot be treated in accordance with the local adalimumab product label.
- Patients treated with > 1 prior biologic DMARD for RA. Any prior treatment with adalimumab is prohibited.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Participants With RA Receiving Adalimumab
Participants with RA who were prescribed adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit. All participants were offered to participate in the PSP while treated with ADA for their RA. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Achieving a Minimal Clinically Important Difference (MCID) in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 78
Time Frame: Baseline, Week 78
|
The HAQ-DI is a self-reported assessment of how the participant's illness affects their ability to function in their daily life over the past week.
The HAQ-DI for a participant is calculated as the mean of the following 8 category scores (range: 0 to 3): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities.
A lower score demonstrates less disability.
The MCID in HAQ-DI was defined as an improvement of at least 0.22 in HAQ-DI compared to Baseline.
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Baseline, Week 78
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Achieving a MCID in the HAQ-DI at Week 12
Time Frame: Baseline, Week 12
|
The HAQ-DI is a self-reported assessment of how the participant's illness affects their ability to function in their daily life over the past week.
The HAQ-DI for a participant is calculated as the mean of the following 8 category scores (range: 0 to 3): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities.
A lower score demonstrates less disability.
The MCID in HAQ-DI was defined as an improvement of at least 0.22 in HAQ-DI compared to Baseline.
|
Baseline, Week 12
|
Percentage of Participants Achieving a MCID in the HAQ-DI at Week 24
Time Frame: Baseline, Week 24
|
The HAQ-DI is a self-reported assessment of how the participant's illness affects their ability to function in their daily life over the past week.
The HAQ-DI for a participant is calculated as the mean of the following 8 category scores (range: 0 to 3): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities.
A lower score demonstrates less disability.
The MCID in HAQ-DI was defined as an improvement of at least 0.22 in HAQ-DI compared to Baseline.
|
Baseline, Week 24
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Percentage of Participants Achieving a MCID in the HAQ-DI at Week 36
Time Frame: Baseline, Week 36
|
The HAQ-DI is a self-reported assessment of how the participant's illness affects their ability to function in their daily life over the past week.
The HAQ-DI for a participant is calculated as the mean of the following 8 category scores (range: 0 to 3): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities.
A lower score demonstrates less disability.
The MCID in HAQ-DI was defined as an improvement of at least 0.22 in HAQ-DI compared to Baseline.
|
Baseline, Week 36
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Percentage of Participants Achieving a MCID in the HAQ-DI at Week 52
Time Frame: Baseline, Week 52
|
The HAQ-DI is a self-reported assessment of how the participant's illness affects their ability to function in their daily life over the past week.
The HAQ-DI for a participant is calculated as the mean of the following 8 category scores (range: 0 to 3): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities.
A lower score demonstrates less disability.
The MCID in HAQ-DI was defined as an improvement of at least 0.22 in HAQ-DI compared to Baseline.
|
Baseline, Week 52
|
Percentage of Participants Achieving a MCID in the HAQ-DI at Week 64
Time Frame: Baseline, Week 64
|
The HAQ-DI is a self-reported assessment of how the participant's illness affects their ability to function in their daily life over the past week.
The HAQ-DI for a participant is calculated as the mean of the following 8 category scores (range: 0 to 3): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities.
A lower score demonstrates less disability.
The MCID in HAQ-DI was defined as an improvement of at least 0.22 in HAQ-DI compared to Baseline.
|
Baseline, Week 64
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Change From Baseline in With 28-Joint Disease Activity Score of C-reactive Protein (DAS28[CRP]) at Weeks 24, 52, and 78
Time Frame: Baseline and Weeks 24, 52, 78
|
The DAS28 is a validated combined index of RA disease activity.
Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score.
Scores on the DAS28 range from 0 to 10, with higher numbers indicating more disease activity.
|
Baseline and Weeks 24, 52, 78
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Mean Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 24, 52, and 78
Time Frame: Baseline, Weeks 24, 52, and 78
|
The SDAI is a validated measure of RA disease activity.
Twenty-eight tender joint counts, 28 swollen joint counts, global disease activity assessed by the participant on a visual analogue scale from 0 to 10 (cm) , global disease activity assessed by an investigator on a visual analogue scale from 0 to 10 (cm), and serum levels of C-reactive protein (mg/dL) were included in the SDAI score.
Scores on the SDAI range from 0 to 86.
An SDAI score ≥26.1 indicates high disease activity, an SDAI score between 11.1 and 26.0 indicates moderate disease activity, an SDAI score between 3.4 and 11.0 indicates low disease activity, and an SDAI score ≤3.3 indicates clinical remission.
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Baseline, Weeks 24, 52, and 78
|
Mean Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 24, 52, and 78
Time Frame: Baseline, Weeks 24, 52, and 78
|
The CDAI is a validated measure of RA disease activity.
Twenty-eight tender joint counts, 28 swollen joint counts, global health assessed by the participant on a visual analogue scale from 0 to 10 (cm), and global health assessed by an investigator on a visual analogue scale from 0 to 10 (cm) were included in the CDAI score.
Scores on the CDAI range from 0 to 76.
A CDAI score ≥22.1 indicates high disease activity, a CDAI score between 10.1 and 22.0 indicates moderate disease activity, a CDAI score between 2.9 and 10.0 indicates low disease activity, and a CDAI score ≤2.8 indicates clinical remission.
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Baseline, Weeks 24, 52, and 78
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Percentage of Participants Achieving American College of Rheumatology 20%, 50%, 70% (ACR20, ACR50, ACR70) Response at Week 78
Time Frame: Week 78
|
ACR20/50/70 response is a 20%/50%/70% improvement in a participant's disease condition compared to Baseline. A participant is considered an ACR20/50/70 responder if the following 3 criteria are met: ≥ 20/50/70% improvement in 28 tender joint count; ≥ 20/50/70% improvement in swollen joint count; ≥ 20/50/70% improvement in at least 3 of the following 5 assessments:
|
Week 78
|
Percentage of Participants With a Good or Moderate European League Against Rheumatism (EULAR) Response (Using DAS28[ESR] at Week 78
Time Frame: Week 78
|
A EULAR response reflects improvement in disease activity and attainment of a lower degree of disease activity based on the DAS28(ESR) score. The DAS28(ESR) score ranges from 0-10, with higher scores indicating more disease activity.
|
Week 78
|
Percentage of Participants With a Good or Moderate EULAR Response (Using DAS28[CRP] at Week 78
Time Frame: Week 78
|
A EULAR response reflects improvement in disease activity and attainment of a lower degree of disease activity based on the DAS28(CRP) score. The DAS28(CRP) score ranges from 0-10, with higher scores indicating more disease activity.
|
Week 78
|
Mean Change From Baseline in Work Productivity and Activity Impairment (WPAI) at Week 24
Time Frame: Baseline, Week 24
|
The WPAI assessed impact of RA on work productivity and non-work activity limitation.
Participants were asked during the past 7 days: how many hours did you miss from work because of problems associated with RA (absenteeism), how many hours did you miss from work because of any other reason, such as vacation, holidays, time off to participate in this study (presenteeism), how much did your RA affect your productivity while you were working (overall work impairment), and much did RA affect your ability to do your regular daily activities, other than work at a job (activity impairment).
Answers were rated on an 11-point scale, with 0 indicating "RA had no effect on this" and 10 indicating "RA completely prevented me from this."
A decrease in the WPAI score indicates improvement.
|
Baseline, Week 24
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Mean Change From Baseline in WPAI at Week 52
Time Frame: Baseline, Week 52
|
The WPAI assessed impact of RA on work productivity and non-work activity limitation.
Participants were asked during the past 7 days: how many hours did you miss from work because of problems associated with RA (absenteeism), how many hours did you miss from work because of any other reason, such as vacation, holidays, time off to participate in this study (presenteeism), how much did your RA affect your productivity while you were working (overall work impairment), and much did RA affect your ability to do your regular daily activities, other than work at a job (activity impairment).
Answers were rated on an 11-point scale, with 0 indicating "RA had no effect on this" and 10 indicating "RA completely prevented me from this."
A decrease in the WPAI score indicates improvement.
|
Baseline, Week 52
|
Mean Change From Baseline in WPAI at Week 78
Time Frame: Baseline, Week 78
|
The WPAI assessed impact of RA on work productivity and non-work activity limitation.
Participants were asked during the past 7 days: how many hours did you miss from work because of problems associated with RA (absenteeism), how many hours did you miss from work because of any other reason, such as vacation, holidays, time off to participate in this study (presenteeism), how much did your RA affect your productivity while you were working (overall work impairment), and much did RA affect your ability to do your regular daily activities, other than work at a job (activity impairment).
Answers were rated on an 11-point scale, with 0 indicating "RA had no effect on this" and 10 indicating "RA completely prevented me from this."
A decrease in the WPAI score indicates improvement.
|
Baseline, Week 78
|
Mean Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Scores at Week 24
Time Frame: Baseline, Week 24
|
TSQM is a 14-point measure to show that adherence is expected to be related with participants' satisfaction with therapy and such satisfaction can be a function of not only the effect of the treatment, but also the services offered.
TSQM responses are used to derive scores for scales measuring effectiveness, side effects, convenience, and global satisfaction (based on participant evaluation over the last 2 to 3 weeks, or since last medication use).
Scores for each of the 4 scales range from 0 to 100 with higher scores indicating a better state or outcome (e.g., greater perceived effectiveness or satisfaction).
|
Baseline, Week 24
|
Mean Change From Baseline in TSQM Scores at Week 52
Time Frame: Baseline, Week 52
|
TSQM is a 14-point measure to show that adherence is expected to be related with participants' satisfaction with therapy and such satisfaction can be a function of not only the effect of the treatment, but also the services offered.
TSQM responses are used to derive scores for scales measuring effectiveness, side effects, convenience, and global satisfaction (based on participant evaluation over the last 2 to 3 weeks, or since last medication use).
Scores for each of the 4 scales range from 0 to 100 with higher scores indicating a better state or outcome (e.g., greater perceived effectiveness or satisfaction).
|
Baseline, Week 52
|
Mean Change From Baseline in TSQM Scores at Week 78
Time Frame: Baseline, Week 78
|
TSQM is a 14-point measure to show that adherence is expected to be related with participants' satisfaction with therapy and such satisfaction can be a function of not only the effect of the treatment, but also the services offered.
TSQM responses are used to derive scores for scales measuring effectiveness, side effects, convenience, and global satisfaction (based on participant evaluation over the last 2 to 3 weeks, or since last medication use).
Scores for each of the 4 scales range from 0 to 100 with higher scores indicating a better state or outcome (e.g., greater perceived effectiveness or satisfaction).
|
Baseline, Week 78
|
Mean Change From Baseline in Compliance Questionnaire Rheumatology (CQR) at Weeks 24, 52, and 78
Time Frame: Baseline, Week 24, 52, and 78
|
The CQR includes 19 items and measures RA treatment-specific compliance/adherence. Participants select an answer based on whether they agree with each statement.
The agreements are based on a 4-point Likert scale with anchors "don't agree at all" (score = 1), "don't agree" (score = 2), "agree" (score = 3), and "agree very much" (score = 4).
The total score is calculated by summing all 19 items and subtracting 19 from the total and dividing by 0.57.
The compliance score ranges between 0 (complete non-compliance) to 100 (perfect compliance).
|
Baseline, Week 24, 52, and 78
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Percentage of Participants Who Demonstrated Improvement From Baseline or Who Remained at Level 4 From Baseline on the Patient Activation Measure (PAM-13) at Week 78
Time Frame: Baseline, Week 78
|
The PAM-13 is a measure used to assess the participant's knowledge, skill, and confidence for self-management of his/her health.
Participants are given a questionnaire of 13 statements to which they responded that they strongly disagree (1), disagree (2), agree (3), or strongly agree (4).
Responses are summed and averaged to come up with an overall score of level 1 through level 4, with higher levels indicating more knowledge, skill and confidence for self-management.
|
Baseline, Week 78
|
Percentage of Participants Who Started and Remained at Level 4 From Baseline to Week 78 on the PAM-13
Time Frame: Baseline, Week 78
|
The PAM-13 is a measure used to assess the participant's knowledge, skill, and confidence for self-management of his/her health.
Participants are given a questionnaire of 13 statements to which they responded that they strongly disagree (1), disagree (2), agree (3), or strongly agree (4).
Responses are summed and averaged to come up with an overall score of level 1 through level 4, with higher levels indicating more knowledge, skill and confidence for self-management.
|
Baseline, Week 78
|
Percentage of Participants Who Started at Level 3 (or Above) at Baseline and Remained at Level 3 or Improved to Level 4 on the PAM-13 at Week 78
Time Frame: Baseline, Week 78
|
The PAM-13 is a measure used to assess the participant's knowledge, skill, and confidence for self-management of his/her health.
Participants are given a questionnaire of 13 statements to which they responded that they strongly disagree (1), disagree (2), agree (3), or strongly agree (4).
Responses are summed and averaged to come up with an overall score of level 1 through level 4, with higher levels indicating more knowledge, skill and confidence for self-management.
|
Baseline, Week 78
|
Change From Baseline Means in the Beliefs About Medicines Questionnaire (BMQ) at Week 78
Time Frame: Baseline, Week 78
|
The BMQ consists of 11 questions used to assess the participant's beliefs about medication and the necessity of medications prescribed to them for rheumatoid arthritis.
Each question answered from 'strongly disagree' to 'strongly agree,' with some questions attributed to the necessity sub-scale, and others to the concern sub-scale.
Each answer is scaled from 1 to 5. The necessity sub-scale is calculated by taking the average of necessity scores, and the concern sub-scale is calculated by taking the average of the concern scores.
Higher scores on the necessity sub-scale represent the stronger perceptions of the participant for the necessity of their medication.
Similarly, higher scores on the concerns sub-scale represent stronger concerns about the potential negative effects of their medications.
|
Baseline, Week 78
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PSP Satisfaction Questionnaire Responses at Week 12
Time Frame: Week 12
|
The PSP satisfaction questionnaire evaluates the participant's satisfaction with specific PSP components as well as overall program satisfaction through the participant's selecting the response that best reflects their opinion: 1=very good; 2=good; 3=less satisfying; 4=I do not use the services.
The percentage of participants at each response level per question is presented.
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Week 12
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PSP Satisfaction Questionnaire Responses at Week 24
Time Frame: Week 24
|
The PSP satisfaction questionnaire evaluates the participant's satisfaction with specific PSP components as well as overall program satisfaction through the participant's selecting the response that best reflects their opinion: 1=very good; 2=good; 3=less satisfying; 4=I do not use the services.
The percentage of participants at each response level per question is presented.
|
Week 24
|
PSP Satisfaction Questionnaire Responses at Week 52
Time Frame: Week 52
|
The PSP satisfaction questionnaire evaluates the participant's satisfaction with specific PSP components as well as overall program satisfaction through the participant's selecting the response that best reflects their opinion: 1=very good; 2=good; 3=less satisfying; 4=I do not use the services.
The percentage of participants at each response level per question is presented.
|
Week 52
|
PSP Satisfaction Questionnaire Responses at Week 78
Time Frame: Week 78
|
The PSP satisfaction questionnaire evaluates the participant's satisfaction with specific PSP components as well as overall program satisfaction through the participant's selecting the response that best reflects their opinion: 1=very good; 2=good; 3=less satisfying; 4=I do not use the services.
The percentage of participants at each response level per question is presented.
|
Week 78
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Jasmina Kalabic, MD, AbbVie
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P12-072
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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