CTRI/2011/091/000575已完成3 期
Phase 3 Randomized, Double Blind, Placebo Controlled Study Of The Efficacy And Safety Of 2 Doses Of CP 690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 750
- 试验地点
- 7
- 主要终点
- To compare the efficacy of 2 doses of CP-690,550 versus placebo for the treatment of signs and symptoms of rheumatoid arthritis as measured by ACR 20 response rates.
研究概览
简要总结
A total of 100 subjects from India will be included in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
入选标准
- •Ages Eligible for Study: 18 Years and older 2.Genders Eligible for Study: Both 3.Accepts Healthy Volunteers: No 4.Adults with moderate to severe rheumatoid arthritis on a stable dose of methotrexate There is no upper age limit for inclusion criteria for this trial.
排除标准
- •Pregnancy, severe or unstable medical conditions, including serious infections (e.g., tuberculosis, HIV), clinically significant laboratory abnormalities (transaminases, hemoglobin), or use of prohibited concomitant medications (all DMARDs except methotrexate).
结局指标
主要结局
To compare the efficacy of 2 doses of CP-690,550 versus placebo for the treatment of signs and symptoms of rheumatoid arthritis as measured by ACR 20 response rates.
时间窗: 6 months.
次要结局
- To compare the efficacy of 2 doses of CP-690,550 versus placebo measured by ACR20, ACR 50, ACR70 and DAS 28 response rates(2 years)
- To compare the durability of ACR20, ACR50, and ACR70 and DAS 28 response rates.(2 years)
- To investigate possible associations between genomic and metabolomic variation in relation to interventions in an optional supplement requiring separate consent not required for participation in primary study(2 years)
- To compare effects on all health outcomes measures in the study at each visit, as appropriate for the specific outcome, compared to baseline.(2 years)
研究者
研究点 (7)
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