Evaluation of Etanercept in Patients With Plaque Psoriasis After Stopping Ciclosporin Therapy
- Registration Number
- NCT00581555
- Lead Sponsor
- Pfizer
- Brief Summary
The purpose of this study is to evaluate the use of etanercept as a replacement therapy for ciclosporin in patients with plaque psoriasis.
- Detailed Description
The purpose of this study is to evaluate the efficacy and safety of etanercept as a replacement therapy for ciclosporin in patients with moderate to severe plaque psoriasis who have achieved an adequate response with ciclosporin.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- Between age 18 and 70 years
- Active and stable plaque psoriasis with a BSA≥10 or PASI≥10.
- Evidence of skin conditions other than psoriasis
- Psoralen plus psoralen + ultraviolet A (PUVA), ciclosporin, acitretin, alefacept, anakinra, or any other systemic anti-psoriasis therapy or disease-modifying antirheumatic drugs (DMARD) with 28 days of screening
- ultraviolet B (UVB) therapy, topical steroids, topical Vitamin A or D analog preparations, or anthralin
- Prior exposure to any TNF-inhibitor. Prior exposure to efalizumab
- Corticosteroid dose of prednisone >10 mg/day
- Serious infection
- Receipt of any live vaccine
- Abnormal hematology or chemistry
- Body mass index (BMI) > 38
- Pregnancy or Breastfeeding
- Significant concurrent medical conditions
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description etanercept Etanercept Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin. placebo Placebo Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
- Primary Outcome Measures
Name Time Method Change From Randomization in PASI Score to Week 24 (Week 18 of Etanercept Monotherapy/Placebo) Randomization to Week 24. PASI score: range: 0 (none) to 72 (maximum). Body was divided into head, upper extremities, trunk and lower extremities; each area score was 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 times area score times weight of section (head: 0.1, upper extremities: 0.2, trunk: 0.3, lower extremities: 0.4). Change = PASI at Week 24 - PASI at baseline.
- Secondary Outcome Measures
Name Time Method PASI Area Under the Curve (AUC) Between Randomization and Week 24 Randomization to Week 24. PASI AUC = Area under the curve from randomization (Week 6) to Week 24.
Change From Randomization in PGA Score to Week 24 Randomization to Week 24. PGA score is based on dermatologist's assessment of disease averaged over all lesions. Overall lesions were graded for individual scores of 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. Change = PGA at Week 24 - PGA at baseline.
Relapse (Loss of 50% Improvement in PASI) During the 24 Weeks After Randomization Randomization to Week 24. Relapse was defined as the loss of 50% improvement in PASI.
Probability of Being Relapse Free During the 24 Weeks After Randomization Randomization to Week 24. Relapse was defined as loss of 50% improvement in PASI. The time to relapse was estimated using a Kaplan-Meier analysis.
Percent (%) Change of PASI Score From Randomization to Week 24 Randomization to Week 24. Percent improvement in PASI score was calculated from Week 6 to Week 24.
Change From Randomization in DLQI to Week 24 Randomization 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).
DLQI at Each Visit From Baseline 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).
Percentage of Rebound Effects Baseline to Week 24. Rebound effects was defined as worsening of psoriasis to 125% of the baseline PASI or appearance of psoriasis variants such as erythrodermic or pustular psoriasis within 12 weeks of discontinuation of therapy.