A Randomized Pilot Study Evaluating the Efficacy and Safety of Etanercept in Patients With Moderate to Severe Plaque Psoriasis After Cessation of Ciclosporin Therapy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 120
- 主要终点
- Change From Randomization in PASI Score to Week 24 (Week 18 of Etanercept Monotherapy/Placebo)
研究概览
简要总结
The purpose of this study is to evaluate the use of etanercept as a replacement therapy for ciclosporin in patients with plaque psoriasis.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between age 18 and 70 years
- •Active and stable plaque psoriasis with a BSA≥10 or PASI≥10.
排除标准
- •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
研究组 & 干预措施
etanercept
Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
干预措施: Etanercept (Drug)
placebo
Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
干预措施: Placebo (Other)
结局指标
主要结局
Change From Randomization in PASI Score to Week 24 (Week 18 of Etanercept Monotherapy/Placebo)
时间窗: 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.
次要结局
- PASI Area Under the Curve (AUC) Between Randomization and Week 24(Randomization to Week 24.)
- Change From Randomization in PGA Score to Week 24(Randomization to Week 24.)
- Relapse (Loss of 50% Improvement in PASI) During the 24 Weeks After Randomization(Randomization to Week 24.)
- Probability of Being Relapse Free During the 24 Weeks After Randomization(Randomization to Week 24.)
- Percent (%) Change of PASI Score From Randomization to Week 24(Randomization to Week 24.)
- Change From Randomization in DLQI to Week 24(Randomization to Week 24.)
- DLQI at Each Visit From Baseline(Baseline to Week 24.)
- Percentage of Rebound Effects(Baseline to Week 24.)