跳至主要内容
临床试验/JPRN-jRCT2080223971
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

发起方
Taisho Pharmaceutical co., LTD

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