A Randomized, Double-blind, Dose-ranging Trial of CNTO 148 Subcutaneous Injection Compared With Placebo in Subjects With Active Rheumatoid Arthritis Despite Treatment With Methotrexate
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 172
- 主要终点
- Number of Participants Meeting the American College of Rheumatology 20 (ACR 20) Response at Week 16
研究概览
简要总结
Multicenter, randomized, double-blind, placebo-controlled, 5-arm, dose-ranging study to assess the efficacy of subcutaneous injections of Golimumab (CNTO 148), 50 or 100 mg, at either 2- or 4- week intervals in subjects with active RA despite MTX therapy.
详细描述
This is an experimental medical research study. The purpose of this study is to determine if Golimumab is safe and effective in the treatment of rheumatoid arthritis.
Subjects will receive subcutaneous injections of either 50 or 100 mg Golimumab or placebo every two or four weeks or an infusion of infliximab at week 20, 22, 28, 36, 44 for 48 weeks
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of RA according to the American College of Rheumatology criteria for at least 3 months prior to screening
- •Have active Rheumatoid Arthritis at the time of screening and at baseline, as defined by 6 or more swollen joints and 6 or more tender joints and additional laboratory criteria
排除标准
- •Have other inflammatory diseases, including but not limited to ankylosing spondylitis, systemic lupus erythematosus, Lyme disease
- •Received disease-modifying antirheumatic drugs ([DMARDs] eg, D penicillamine, hydroxychloroquine, chloroquine, oral or parenteral gold, interleukin [IL]-1 receptor antagonist [anakinra], azathioprine, sulphasalazine, agents other than MTX) within 4 weeks prior to the first study dose
研究组 & 干预措施
Golimumab (CNTO 148) with Methotrexate (MTX)
干预措施: Golimumab (Drug)
Golimumab (CNTO 148) with Methotrexate (MTX)
干预措施: MTX (Drug)
Infliximab with MTX
干预措施: MTX (Drug)
Infliximab with MTX
干预措施: Infliximab (Drug)
Placebo with MTX
干预措施: MTX (Drug)
Placebo with MTX
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants Meeting the American College of Rheumatology 20 (ACR 20) Response at Week 16
时间窗: Week 16
ACR 20 response is a decrease of at least 20 per cent in both tender and swollen joint count and in 3 to 5 assessments (participant's assessment of pain visual analog scale \[VAS\] with 0, no pain to 10, worst pain; patient's and physician's global assessment of disease activity VAS scales: overall disease activity \[0, very well to 10, very poor and 0, no arthritis activity to 10, extremely active, respectively\]; Health Assessment Questionnaire \[HAQ\]: 20-questions on life activities \[0, no difficulty to 3, inability to perform a task\]; C-reactive protein\[CRP\]).
次要结局
- Summary of ACR-N, Index of Improvement at Week 16(Week 16)