CTRI/2009/091/000596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 Monotherapy In Patients With Active Rheumatoid Arthritis - none
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •a. Ages Eligible for Study:18 Years and older,
- •b. Genders Eligible for Study:Both,
- •c. Accepts Healthy Volunteers:No,
- •1. The patient has a diagnosis of RA based upon the American College of Rheumatology (ACR) 1987 Revised Criteria.
- •2. The patient has active disease at both Screening and Baseline, as defined by both greaterthan equal to 6 joints tender or painful on motion; and greaterthan equal to 6 joints swollen; and fulfills 1 of the following 2 criteria at Screening: 1.ESR (Westergren method) greaterthan equal to 28 mm in the local laboratory. 2. CRP greaterthan 7 mg/L in the central laboratory
- •3. Patient had an inadequate response to at least one DMARD (traditional or biologic) due to lack of efficacy or toxicity.
- •4. No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis.
- •5. Patient has washed out of all DMARDs other that antimalarials
- •There is no upper age limit for inclusion criteria for this trial
排除标准
- •-Blood dyscrasias including confirmed: 1. Hemoglobin <9 g/dL or Hematocrit <30%; 2. White blood cell count <3.0 x 109/L; 3.
- •Absolute neutrophil count <1.2 x 109/L; 4. Platelet count <100 x 109/L
- •-History of any other autoimmune rheumatic disease other than Sjogren's syndrome
- •-No malignancy or history of malignancy.
- •?History of infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator, within the 6 months prior to the first dose of study drug
研究者
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