EUCTR2004-003733-14-FI进行中（未招募）1 期
A randomized, double-blind, parallel group study of the safety and prevention of structural joint damage during treatment with MRA versus placebo, in combination with methotrexate, in patients with moderate to severe active rheumatoid arthritis. - LITHE
F. Hoffmann La-Roche Ltd.0 个研究点目标入组 1,170 人开始时间: 2004年11月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,170
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- adult patients at least 18 years of age with moderate to severe active RA for at least 6 months
- •- inadequate response to a stable dose of MTX
- •-patients of reproductive potential must be using reliable methods of contraception
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1009
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 187
排除标准
- •- major surgery (including joint surgery) within eight weeks before entering study, or planned surgery within 6 months after entering study
- •-prior treatment failure with an anti-tumor necrosis factor agent
- •- women who are prgenant or breast-feeding
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