jRCT2080223971已完成3 期
A Phase II/III Study of TS-152 in Patients with Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response to Methotrexate (MTX) Therapy
Taisho Pharmaceutical co., LTD1 个研究点目标入组 370 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 370
- 试验地点
- 1
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Multicenter study - Treatment period A Randomized, Placebo-controlled, Double-blind, Parallel-group - Treatment period B Open-label
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 20age old over 至 75age old under（—）
- 性别
- All
入选标准
- •Patients diagnosed with RA based on the American College of Rheumatology (ACR) 2010 revised criteria for classification of RA
排除标准
- •Patients who are observed any abnormal findings suggestive of malignant tumor, infection, or interstitial pneumonia.
- •Patients with severe cardiovascular, hepatic, and/or renal diseases.
结局指标
主要结局
-
efficacy safety ACR20, Modified Total Sharp Score (mTSS)
次要结局
未报告次要终点
研究者
研究点 (1)
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