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
- Conditions
- Rheumatoid Arthritis (RA)
- Registration Number
- JPRN-jRCT2080223971
- Lead Sponsor
- Taisho Pharmaceutical co., LTD
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 381
Patients diagnosed with RA based on the American College of Rheumatology (ACR) 2010 revised criteria for classification of RA
etc.
- Patients who are observed any abnormal findings suggestive of malignant tumor, infection, or interstitial pneumonia.
- Patients with severe cardiovascular, hepatic, and/or renal diseases.
etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>safety<br>ACR20, Modified Total Sharp Score (mTSS)
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>ACR50, ACR70, DAS28-CRP, DAS28-ESR etc.