JPRN-jRCT2080223971已完成2 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., LTD0 个研究点目标入组 381 人开始时间: 2018年7月9日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 381
研究概览
简要总结
In patients with active RA who had an inadequate response to MTX, TS-152 30 and 80 mg subcutaneously once every 4 weeks demonstrated significant improvement in ACR20 response rate at week 16 compared with placebo, and the efficacy in the TS-152 groups was comparable at both doses. There was no significant difference in the change from baseline in mTSS at week 24 between TS-152 and placebo groups. TS-152 was well tolerated with no notable safety concerns up to week 52 at both doses.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 75age old(—)
- 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.
研究者
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