A 12-Week, Double-Blind, Randomized, Parallel Group, Placebo Controlled Study of Two Doses of VX-702 in Subjects With Moderate to Severe Rheumatoid Arthritis

Vertex Pharmaceuticals Incorporated63 个研究点分布在 11 个国家目标入组 300 人开始时间: 2005年6月最近更新: 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: 300
试验地点: 63
主要终点: The primary endpoint for the study is the ACR20 response at Week 12.

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 clinical activity and safety of two doses of VX-702 compared to placebo in subjects with moderate to severe Rheumatoid Arthritis.

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

•Adults with active rheumatoid arthritis for greater than 6 months and evidence of inflammation.

排除标准

•Subjects who have conditions precluding the use of cytokine inhibitors or subjects who require DMARDs other than hydroxychloroquine or sulfasalazine are excluded.

结局指标

主要结局

The primary endpoint for the study is the ACR20 response at Week 12.

次要结局

The ACR50 and ACR70 responses at 12 weeks will also be assessed as well as other measures.

研究者

发起方

Vertex Pharmaceuticals Incorporated

申办方类型

Industry

研究点 (63)

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