jRCT2080223262已完成2 期
Phase 2, Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety/Pharmacokinetics of BMS-986142 in Subjects With Moderate to Severe Rheumatoid Arthritis With an Inadequate Response to Methotrexate With or Without TNF Inhibitors
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 408
- 试验地点
- 1
- 主要终点
- ACR70 response rate
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 18age old over 至 120age old under（—）
- 性别
- All
入选标准
- •Diagnosed with active rheumatoid arthritis (RA) by standard criteria at least 16 weeks before screening, have functional ACR class I-III
- •Have an inadequate response to methotrexate
- •In addition to an inadequate response to methotrexate have an inadequate response or intolerance to 1 but not more than 2 TNF inhibitors
- •Have a minimum of 6 swollen and 6 tender joints (from 66/68 joint count)
- •Have hsCRP of not less than 0.8 mg/dL (8mg/L) [by central laboratory values] or an ESR not less than 28 mm/hr
- •Willing to use effective birth control for the entire length of the study
排除标准
- •Diagnosed with juvenile Rheumatoid Arthritis
- •Have been treated with other biologic treatment than a TNF inhibitor
- •Active systemic bacterial, viral or fungal infection or evidence of prior or current Hepatitis B or C infection or HIV infection, latent bacterial, viral or fungal infections
- •Have been treated with Intramuscular or Intra-articular glucocorticosteroids within 4 weeks of randomization
- •Taking Oral steroids at dose above 10 mg/day of prednisone (or prednisone equivalents)
- •Have other autoimmune disease other than RA like lupus, multiple sclerosis
- •Have significant concurrent medical condition at the time of screening or baseline visit
结局指标
主要结局
ACR70 response rate
时间窗: At week 12
Proportion of subjects who achieve ACR70 response rate
ACR20 response rate
时间窗: At week 12
Proportion of subjects who achieve ACR20 response rate
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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