CTRI/2010/091/001027已完成3 期
Phase 3 Randomized, Double-Blind Study Of The Efficacy And Safety Of 2 Doses Of CP-690,550 Compared To Methotrexate In Methotrexate-Naive Patients With Rheumatoid Arthritis - Not applicable
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 960
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
- •1. Adults with moderate to severe RA (Rheumatoid Arthritis) who have not been treated with methotrexate or have received less than or equal to 3 doses of MTX, not stopped due to related adverse events.
- •2.Diagnosis of RA based on the American College of Rheumatology 1987 revised criteria.
- •3.Active disease as defined by both greater than equal to 6 tender or painful joints on motion and greater than equal to 6 joints swollen, and either an erythrocyte sedimentation rate (ESR) is greater than 28 mm or a C-reactive protein (CRP) concentration is greater than 7 mg/dL
排除标准
- •-Blood dyscrasias including confirmed: Hemoglobin <9 g/dL or Hematocrit <30%; White blood cell count <3.0 x 109/L; Absolute neutrophil count <1.2 x 109/L; Platelet count <100 x 109/L
- •-History of any other rheumatic autoimmune 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
- •-No chronic liver disease, recent or active hepatitis or other contraindication to methotrexate therapy
研究者
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