- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00663052
Study Evaluating Etanercept for the Treatment of Moderate to Severe Psoriasis (PRISTINE)
March 29, 2012 updated by: Pfizer
A Randomized, Double-Blind Trial Assessing the Efficacy and Safety of Etanercept 50 mg Twice Weekly and Etanercept 50 mg Once Weekly for the Treatment of Moderate to Severe Psoriasis
The purpose of this study is to compare the safety and efficacy of different doses of etanercept for the treatment of moderate to severe psoriasis.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
273
Phase
- Phase 4
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
-
-
Buenos Aires
-
Capital Federal, Buenos Aires, Argentina, 01114
- Pfizer Investigational Site
-
Capital Federal, Buenos Aires, Argentina, 01199
- Pfizer Investigational Site
-
San Miguel, Buenos Aires, Argentina, 1684
- Pfizer Investigational Site
-
-
-
-
-
Feldkirch, Austria
- Pfizer Investigational Site
-
Wien, Austria, 1030
- Pfizer Investigational Site
-
-
-
-
-
Bruxelles, Belgium, B-1200
- Pfizer Investigational Site
-
Gent, Belgium, 9000
- Pfizer Investigational Site
-
Liege, Belgium, 4020
- Pfizer Investigational Site
-
-
-
-
-
Jihlava, Czech Republic, 586 33
- Pfizer Investigational Site
-
Ostrava- Poruba, Czech Republic, 708 00
- Pfizer Investigational Site
-
Plzen-Bory, Czech Republic, 305 99
- Pfizer Investigational Site
-
-
-
-
-
Bochum, Germany, 44791
- Pfizer Investigational Site
-
Erlangen, Germany, 91052
- Pfizer Investigational Site
-
Frankfurt am Main, Germany, 60590
- Pfizer Investigational Site
-
Hamburg, Germany, 20246
- Pfizer Investigational Site
-
Kiel, Germany, 24105
- Pfizer Investigational Site
-
Muenchen, Germany, 80802
- Pfizer Investigational Site
-
Osnabrueck, Germany, 49078
- Pfizer Investigational Site
-
-
-
-
-
Athens, Greece, 124 62
- Pfizer Investigational Site
-
Athens, Greece, 16121
- Pfizer Investigational Site
-
-
-
-
-
Budapest, Hungary, 1085
- Pfizer Investigational Site
-
Debrecen, Hungary, 4012
- Pfizer Investigational Site
-
Miskolc, Hungary, 3529
- Pfizer Investigational Site
-
Szeged, Hungary, 6720
- Pfizer Investigational Site
-
-
-
-
-
Catanzaro, Italy, 88110
- Pfizer Investigational Site
-
L'Aquila, Italy, 67100
- Pfizer Investigational Site
-
-
-
-
-
Gangnam-gu, Korea, Republic of, 135-710
- Pfizer Investigational Site
-
Seoul, Korea, Republic of, 110-744
- Pfizer Investigational Site
-
-
-
-
Jalisco
-
Zapopan, Jalisco, Mexico, 45190
- Pfizer Investigational Site
-
-
Nuevo Leon
-
Monterrey, Nuevo Leon, Mexico, 64710
- Pfizer Investigational Site
-
-
Nuevo Leon / Mexico
-
Monterrey, Nuevo Leon / Mexico, Mexico, 64020
- Pfizer Investigational Site
-
-
-
-
-
Barcelona, Spain, 08025
- Pfizer Investigational Site
-
Valencia, Spain, 46014
- Pfizer Investigational Site
-
-
La Coruña
-
Santiago de Compostela, La Coruña, Spain, 15706
- Pfizer Investigational Site
-
-
Madrid
-
Fuenlabrada, Madrid, Spain, 28942
- Pfizer Investigational Site
-
-
-
-
-
Taipei, Taiwan, 110
- Pfizer Investigational Site
-
Taipei TOC, Taiwan, 100
- Pfizer Investigational Site
-
-
-
-
-
Bangkok, Thailand
- Pfizer Investigational Site
-
-
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
Description
Inclusion Criteria:
- 18 years of age or older at time of consent.
- Active, moderate to severe chronic plaque psoriasis defined by the following criteria: Clinically stable, plaque psoriasis involving greater than or equal to 10% body surface area (BSA) or PASI greater than or equal to 10.
- In the opinion of the investigator, failure, intolerance, contraindication or not a candidate for the following: Methotrexate (MTX), cyclosporine and psoralen plus ultraviolet A radiation (PUVA) therapy.
Exclusion Criteria:
- Evidence of skin conditions (e.g., eczema) other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasis.
- Rheumatologic disease such as rheumatoid arthritis, systemic lupus erythematous, systemic vasculitis, scleroderma and polymyositis, or associated syndromes.
- Active or recent (within 2 years) tuberculosis (TB) infection.
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
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A
A
|
ETN 50 mg QW + PBO QW for 12 weeks followed by ETN 50 mg QW for 12 weeks.
ETN 50 mg BIW for 12 weeks folowed ETN 50 mg QW for 12 weeks.
|
|
Experimental: Group B
B
|
ETN 50 mg QW + PBO QW for 12 weeks followed by ETN 50 mg QW for 12 weeks.
ETN 50 mg BIW for 12 weeks folowed ETN 50 mg QW for 12 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of Participants Achieving a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 24
Time Frame: Week 24
|
PASI: Combined assessment of lesion severity and area affected into single score; range: 0(no disease) to 72(maximal disease).
Body was divided into 4 sections (head, arms, trunk, legs); each area was scored by itself and scores were combined for final PASI.
For each section percent area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum).
Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).
|
Week 24
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of Participants Achieving a 50% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24
Time Frame: Baseline to Week 24
|
PASI: Combined assessment of lesion severity and area affected into single score; range: 0(no disease) to 72(maximal disease).
Body was divided into 4 sections (head, arms, trunk, legs); each area was scored by itself and scores were combined for final PASI.
For each section percent area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum).
Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).
|
Baseline to Week 24
|
|
Percentage of Participants Achieving a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24
Time Frame: Baseline to Week 24
|
PASI: Combined assessment of lesion severity and area affected into single score; range: 0(no disease) to 72(maximal disease).
Body was divided into 4 sections (head, arms, trunk, legs); each area was scored by itself and scores were combined for final PASI.
For each section percent area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum).
Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).
|
Baseline to Week 24
|
|
Percentage of Participants Achieving a 90% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24
Time Frame: Baseline to week 24
|
PASI: Combined assessment of lesion severity and area affected into single score; range: 0(no disease) to 72(maximal disease).
Body was divided into 4 sections (head, arms, trunk, legs); each area was scored by itself and scores were combined for final PASI.
For each section percent area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum).
Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).
|
Baseline to week 24
|
|
Percentage of Participants Achieving a 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24
Time Frame: Baseline to Week 24
|
PASI: Combined assessment of lesion severity and area affected into single score; range: 0(no disease) to 72(maximal disease).
Body was divided into 4 sections (head, arms, trunk, legs); each area was scored by itself and scores were combined for final PASI.
For each section percent area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum).
Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).
|
Baseline to Week 24
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24
Time Frame: Baseline to Week 24
|
PASI: Combined assessment of lesion severity and area affected into single score; range: 0(no disease) to 72(maximal disease).
Body was divided into 4 sections (head, arms, trunk, legs); each area scored by itself and scores were combined for final PASI.
For each section, percent area of skin involved estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum).
Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).
|
Baseline to Week 24
|
|
Time to Achieve Psoriasis Area and Severity Index (PASI) 50, PASI 75 and PASI 100 Over 24 Weeks
Time Frame: Baseline to Week 24
|
Time taken to achieve first PASI was calculated using Kaplan-Meier estimate and presented as median.
PASI 50=50% improvement from baseline in PASI; PASI 75=75% improvement from baseline in PASI; PASI 90=90% improvement from baseline in PASI; PASI 100=100% improvement from baseline in PASI.
PASI score percent improvement =100*(baseline score - visit score)/baseline score.
|
Baseline to Week 24
|
|
Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses of Clear (0) at Each Visit Through Week 24
Time Frame: Baseline to Week 24
|
PGA of Psoriasis: score based on dermatologist's assessment of head, scalp, and neck psoriasis (averaged over all lesions).
The PGA of Psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease).
PGA score of 0 = Status of Clear.
|
Baseline to Week 24
|
|
Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses Clear/Almost Clear (0, 1) at Each Visit Through Week 24
Time Frame: Baseline to Week 24
|
PGA of Psoriasis: score based on dermatologist's assessment of head, scalp, and neck psoriasis (averaged over all lesions).
The PGA of Psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease).
PGA score of 0 = Status of Clear; 1 = Almost Clear.
|
Baseline to Week 24
|
|
Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses of Clear/Almost Clear/Mild (0, 1, 2) at Each Visit Through Week 24
Time Frame: Baseline to Week 24
|
PGA of Psoriasis: score based on dermatologist's assessment of head, scalp, and neck psoriasis (averaged over all lesions).
The PGA of Psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease).
PGA score of 0 = Status of Clear; 1 = Almost Clear and 2 = Mild.
|
Baseline to Week 24
|
|
Time to First Physician Global Assessment (PGA) of Psoriasis of Clear/Almost Clear (0, 1), or Clear/Almost Clear/Mild (0, 1, 2) Over 24 Weeks
Time Frame: Baseline to Week 24
|
Time taken to achieve PGA was calculated using Kaplan-Meier estimate and presented as median.
Assessment of clear or almost clear or Mild = PGA score of 0 (no evidence) or 1 (minimal/faint) or 2 (mild plaque elevation, mild fine scales predominates or light red coloration).
|
Baseline to Week 24
|
|
Change From Baseline in Physician Global Assessment (PGA) of Psoriasis at Each Visit Through Week 24
Time Frame: Baseline to Week 24
|
PGA of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of head, scalp, and neck.
Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe).
The sum of the 3 scores was divided by 3 to obtain a final PGA score.
Higher scores indicate greater severity of disease.
|
Baseline to Week 24
|
|
Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Each Visit Through Week 24
Time Frame: Baseline to Week 24
|
Baseline to Week 24
|
|
|
Change From Baseline in the Photographed Image of Lesions in Selected Participants
Time Frame: Baseline to Week 24
|
Compare the before and after photographs with the clinical assessments (Psoriasis Area and Severity Index, Physician's Global Assessment) taken at the same time for illustration purposes.
Measured as yes or no for change.
|
Baseline to Week 24
|
|
Percentage of Participants Not Using Topical Preparations at Each Visit From Week 12 Through Week 24
Time Frame: From Week 12 to Week 24
|
Moderate topical steroids to very potent topical steroids, topical vitamin D analogs, topical steroids in combination with vitamin D analogs, and anthralin compounds were prohibited for 14 days before the baseline visit until week 12.
|
From Week 12 to Week 24
|
|
Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 12
Time Frame: Week 12
|
PSSQ: participant's assessment that includes 18 items, 16 items (1-16) scored using Likert score with scores from 0 (very dissatisfied) to 4 (very satisfied) and 5 ( never had this problem).
Only those participants who do not have score of 5 at baseline included in the item 1-16 analyses.
Two items (17, 18) are with Yes/No answers.
The scores of items 1-16 for change from baseline are summarized here.
|
Week 12
|
|
Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 24
Time Frame: Week 24
|
PSSQ: participant's assessment that includes 18 items, 16 items (1-16) scored using Likert score with scores from 0 (very dissatisfied) to 4 (very satisfied) and 5 (never had this problem).
Only those participants who do not have score of 5 at baseline included in the item 1-16 analyses.
Two items (17, 18) are with Yes/No answers.
The scores of items 1-16 for change from baseline are summarized here.
|
Week 24
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change From Baseline in Subject Global Assessment (SGA) of Itching at Each Visit Through Week 24
Time Frame: Baseline to Week 24
|
SGA of Psoriasis: score based on participant's assessment of itching at a scale of 0 to 5; where 0 = no itching and 5 = severe itching.
|
Baseline to Week 24
|
|
Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Each Visit Through Week 24
Time Frame: Baseline to Week 24
|
SGA of Joint Pain: score based on participant's assessment of joint pain at a scale of 0 to 5; where 0 = no pain and 5 = severe pain.
|
Baseline to Week 24
|
|
Change From Baseline in Subject Global Assessment (SGA) of Psoriasis at Each Visit Through Week 24
Time Frame: Baseline to Week 24
|
SGA of Psoriasis: score based on participant's assessment of psoriasis disease activity at a scale of 0 to 5; where 0 = good and 5 = severe.
|
Baseline to Week 24
|
|
Change From Baseline in Psoriatic Arthritis Screening and Evaluation (PASE) Total Score at Week 12
Time Frame: Baseline, Week 12
|
PASE a participant-administered questionnaire and a simple scoring system to assist physicians in screening participants with psoriasis for evidence of psoriatic arthritis with two sub-scales: system sub-scale and function sub-scale.
Total of 15 questions in both sub-scales (7 questions in system and 8 in function sub-scale) to score from 1 to 5; where 1 = strongly disagree and 5 = strongly agree.
The total of system and function scores provides the total PASE score ranging from 15 to 75 where higher scores indicate greater severity.
|
Baseline, Week 12
|
|
Percentage of Participants Evaluated Using Psoriasis Physician Satisfaction Questionnaire (PPSQ): Consider Patient's Condition Satisfactory From Baseline at Each Visit Through Week 24
Time Frame: Baseline to Week 24
|
Physician Psoriasis Satisfaction Questionnaire (PPSQ) included two global satisfaction questions to which physicians respond either 'satisfactory' or 'not satisfactory.'
These are: 1) whether the participant's current condition is satisfactory, considering psoriasis symptoms, skin appearance and all other problems that psoriasis causes; 2) whether the participant's current primary psoriasis therapy is satisfactory, considering psoriasis symptoms, skin appearance, therapy side effects and therapy ease/difficulty of use.
Each of these questions was summarized for change from baseline.
|
Baseline to Week 24
|
|
Percentage of Participants Evaluated by Physicians Using Psoriasis Physician Satisfaction Questionnaire (PPSQ): Consider Primary Psoriasis Therapy Satisfactory From Baseline at Each Visit Through Week 24
Time Frame: Baseline to Week 24
|
Physician Psoriasis Satisfaction Questionnaire (PPSQ) includes two global satisfaction questions to which physicians respond either 'satisfactory' or 'not satisfactory.'
These are: 1) whether the participant's current condition is satisfactory, considering psoriasis symptoms, skin appearance and all other problems that psoriasis causes; 2) whether the participant's current primary psoriasis therapy is satisfactory, considering psoriasis symptoms, skin appearance, therapy side effects and therapy ease/difficulty of use.
Each of these questions was summarized for change from baseline.
|
Baseline to Week 24
|
|
Percentage of Participants Who Were Considered Satisfied With Health State According to Psoriasis Subject Satisfaction Questionnaire (PSSQ)
Time Frame: Baseline to Week 24
|
PSSQ: participant's assessment that includes 18 items, 16 items (1-16) scored using Likert score with scores from 0 (very dissatisfied) to 4 (very satisfied) and 5 (never had this problem).
Only those participants who do not have score of 5 at baseline included in the item 1-16 analyses.
Two items (17, 18) with Yes/No answers are summarized here.
|
Baseline to Week 24
|
|
Percentage of Participants Who Were Considered Satisfied With Primary Psoriasis Treatment According to Psoriasis Subject Satisfaction Questionnaire (PSSQ)
Time Frame: Baseline to Week 24
|
PSSQ: participant's assessment that includes 18 items, 16 items (1-16) scored using Likert score with scores from 0 (very dissatisfied) to 4 (very satisfied) and 5 (never had this problem).
Only those participants who do not have score of 5 at baseline included in the item 1-16 analyses.
Two items (17, 18) with Yes/No answers are summarized here.
|
Baseline to Week 24
|
|
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score to Week 24
Time Frame: Baseline to Week 24
|
DLQI is the dermatology-specific quality of life measure used for psoriatic population.
The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life.
An estimate of the minimal clinically important difference of the DLQI total score is a 5 point improvement.
Total score range: 0 (best) to 30 (worst).
|
Baseline to Week 24
|
|
Change From Baseline in the Euro Quality of Life 5 Dimension (EQ-5D) Utility Index
Time Frame: Baseline, Week 12 and Week 24
|
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (example "confined to bed").
Scoring formula developed by EuroQol Group assigns utility value for each domain in the profile.
Score is transformed and results in total score range -0.594 to 1.000; higher score indicates better health state.
|
Baseline, Week 12 and Week 24
|
|
Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) - Anxiety Score
Time Frame: Baseline, Week 12 and Week 24
|
HADS: participant rated questionnaire with 2 subscales.
HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone).
Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression).
Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.
|
Baseline, Week 12 and Week 24
|
|
Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) - Depression Score
Time Frame: Baseline, Week 12 and Week 24
|
HADS: participant rated questionnaire with 2 subscales.
HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone).
Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression).
Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.
|
Baseline, Week 12 and Week 24
|
|
Work Productivity and Activity Impairment: Psoriasis (WPAI:PSO) at Week 12
Time Frame: Week 12
|
WPAI:PSO - participant rated questionnaire to assess effect of psoriasis on ability to work and perform regular activities in 4 areas: percent activity impairment (0 [no effect on daily activities] to 100 [psoriasis completely prevented from doing daily activities]), percent impairment while working (0 [no effect] to 100 [completely prevented from working]); percent work time missed due to psoriasis, and percent overall work impairment (0 [no effect] to 100 [completely prevented from working]).
|
Week 12
|
|
Work Productivity and Activity Impairment: Psoriasis (WPAI:PSO) at Week 24
Time Frame: Week 24
|
WPAI:PSO - participant rated questionnaire to assess effect of psoriasis on ability to work and perform regular activities in 4 areas: percent activity impairment (0 [no effect on daily activities] to 100 [psoriasis completely prevented from doing daily activities]), percent impairment while working (0 [no effect] to 100 [completely prevented from working]); percent work time missed due to psoriasis, and percent overall work impairment (0 [no effect] to 100 [completely prevented from working]).
|
Week 24
|
|
Mean Medical Outcomes Study (MOS) Sleep Scale Scores at Week 12
Time Frame: Week 12
|
MOS scale has 12 questions to assess sleep quality & quantity: 1)time to fall asleep, 2)hours of sleep/night in past 4 weeks,3)sleep not peaceful, 4)got enough sleep to feel rested in morning,5)awaken short of breath/headache 6)feel drowsy in day,7)trouble going to sleep, 8)wake up during sleep; trouble going back to sleep,9)trouble staying awake in day, 10)Snoring,11)take naps in day,12)get amount of sleep needed.
Sleep problem index(SPI) I:mean of 4,5,7,8,9,12; SPI II:mean of 1,3,4,5,6,7,8,9,12.
All reported responses are on scale:0-100, higher scores indicate greater intensity of attribute.
|
Week 12
|
|
Mean Medical Outcomes Study (MOS) Sleep Scale Scores at Week 24
Time Frame: Week 24
|
MOS: participant rated questionnaire to assess sleep quality and quantity.
Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with headache, somnolence adequacy, and sleep quantity.
Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.
|
Week 24
|
|
Mean Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Questionnaire Total Scores
Time Frame: Week 12 and Week 24
|
FACIT Fatigue questionnaire: Participant rated 13 items questionnaire to assess fatigue.
For each question, participant rates his / her condition for the past week on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much).
Higher scores always represent less fatigue.
The total FACIT-Fatigue score ranges from 0 to 52 and is the sum of non-missing item scores; divided by the number of non-missing items, then multiplied by 13.
If more than 6 items were missing, the total score was missing.
|
Week 12 and Week 24
|
|
Percentage of Participants With Emergency Room Visits
Time Frame: Week 12 and Week 24
|
As a part of pharmacoeconomic questionnaire, the visits to emergency room were evaluated and presented as Yes or No.
|
Week 12 and Week 24
|
|
Mean Number of Emergency Room Days
Time Frame: Week 12 and Week 24
|
As a part of pharmacoeconomic questionnaire, mean number of emergency room days were summarized.
|
Week 12 and Week 24
|
|
Percentage of Participants With Doctor Visits
Time Frame: Week 12 and Week 24
|
As a part of pharmacoeconomic questionnaire, the percentage of participants who had doctor visits were presented as Yes or No.
|
Week 12 and Week 24
|
|
Mean Number of Doctor Visits
Time Frame: Week 12 and Week 24
|
As a part of pharmacoeconomic questionnaire, the mean number of doctor visits were summarized.
|
Week 12 and Week 24
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.
General Publications
- Kemeny L, Amaya M, Cetkovska P, Rajatanavin N, Lee WR, Szumski A, Marshall L, Mahgoub EY, Aldinc E. Effect of etanercept therapy on psoriasis symptoms in patients from Latin America, Central Europe, and Asia: a subset analysis of the PRISTINE trial. BMC Dermatol. 2015 May 21;15:9. doi: 10.1186/s12895-015-0028-8.
- Griffiths CE, Christophers E, Szumski A, Jones H, Mallbris L. Impact of early vs. late disease onset on treatment response to etanercept in patients with psoriasis. Br J Dermatol. 2015 Nov;173(5):1271-3. doi: 10.1111/bjd.13865. Epub 2015 Aug 17. No abstract available.
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
June 1, 2008
Primary Completion (Actual)
January 1, 2010
Study Completion (Actual)
January 1, 2010
Study Registration Dates
First Submitted
April 17, 2008
First Submitted That Met QC Criteria
April 17, 2008
First Posted (Estimate)
April 21, 2008
Study Record Updates
Last Update Posted (Estimate)
April 23, 2012
Last Update Submitted That Met QC Criteria
March 29, 2012
Last Verified
March 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Skin Diseases, Papulosquamous
- Psoriasis
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Gastrointestinal Agents
- Etanercept
Other Study ID Numbers
- 0881A6-4425
- B1801013
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.