A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Dose Ranging, Multi-Center Study to Evaluate the Efficacy and Safety of BMS-945429 Subcutaneous Injection in Adults With Active Psoriatic Arthritis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- CSL Behring
- 入组人数
- 165
- 试验地点
- 61
- 主要终点
- Percent of Participants Achieving American College of Rheumatology Criteria 20% Response Rate (ACR20)
研究概览
简要总结
The purpose of this study is to characterize the safety, efficacy and dose response of BMS-945429 in subjects with active Psoriatic Arthritis and an inadequate response to Nonsteroidal anti-inflammatory drugs (NSAIDs) and non-biologic Disease modifying anti-rheumatic drugs (DMARDs).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be on a stable background Methotrexate (MTX) therapy prior to Day1/Randomization. Subjects must have taken MTX for at least 3 months at a dose ≥ 15 mg/week to a maximum weekly dose of ≤ 25 mg/week, and be at a stable dose for 4 weeks prior to randomization (Day 1). Methotrexate dose ≥ 15 mg/week that was not efficacious and that was decreased due to toxicity as low as 10 mg/week is allowed
- •Inadequate response to NSAID and/or non-biologic DMARD
- •Minimum of 3 swollen and 3 tender joints
- •Active psoriatic skin lesions over minimum 3% body surface area
- •high sensitivity C-reactive protein (hsCRP) ≥ 0.3 mg/dL
排除标准
- •Previously received or currently receiving concomitant biologic therapy
结局指标
主要结局
Percent of Participants Achieving American College of Rheumatology Criteria 20% Response Rate (ACR20)
时间窗: At 16 weeks
The ACR20/50/70 is a composite measure defined as both improvement of 20%, 50% or 70% in the number of tender and number of swollen joints, and a 20%, 50% or 70% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure \[most often Health Assessment Questionnaire (HAQ)\], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP).
次要结局
- Percent of Participants Achieving ACR50 and ACR70 Response Rate(Week 16 and Week 24)
- Percent of Participants Achieving ACR20 Response Rate at Week 24(Week 24)
- Percent of Participants Achieving a Health Assessment Questionnaire (HAQ) Response(Weeks 16 and Week 24)
- Number of Participants With Anti-clazakizumab Antibodies(Up to 24 weeks)
- Percent of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Response Rate(Week 16 and Week 24)
- Mean Change From Baseline at Week 16 in Short Form (36) [SF-36] Scores(Baseline and Week 16)
- Mean Change From Baseline at Week 24 in SF-36 Scores(Baseline and Week 24)