A Phase 2, 12-Week, Randomized, Placebo-Controlled Study to Evaluate the Antiinflammatory Effects of VX-702 When Administered Concomitantly With Methotrexate

Vertex Pharmaceuticals Incorporated17 个研究点分布在 6 个国家目标入组 120 人开始时间: 2006年11月1日最近更新: 2007年12月7日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方: Vertex Pharmaceuticals Incorporated
入组人数: 120
试验地点: 17
主要终点: To evaluate the effects of VX-702 administered with concomitant methotrexate (MTX), and MTX alone

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to assess the safety and effects of VX-702 in subjects with moderate to severe rheumatoid arthritis and who are taking the drug methotrexate.

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

入排标准

年龄范围: 18 Years 至 75 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Adult patients 18 to 75 years of age with active RA
•Must have been taking MTX for at least 6 months
•No concurrent DMARD treatment (other than a stable dose of MTX)

排除标准

•Planned major surgery (e.g., joint replacement) within the duration of the treatment period of the study
•Treated with intra-articular injections of corticosteroids within 28 days prior to Day 1

结局指标

主要结局

To evaluate the effects of VX-702 administered with concomitant methotrexate (MTX), and MTX alone

次要结局

To evaluate the safety and tolerability of VX-702 administered with concomitant MTX, and MTX alone

研究者

发起方

Vertex Pharmaceuticals Incorporated

申办方类型

Industry

研究点 (17)

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