An Early Phase-II, Randomized, Double-blind, Study of TAS5315 in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate
Phase 2
Completed
- Conditions
- rheumatoid arthritis
- Registration Number
- JPRN-jRCT2080223962
- Lead Sponsor
- Taiho Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 90
Inclusion Criteria
Have a diagnosis of RA according to 2010 ACR/ EULAR rheumatoid arthritis (RA) classification criteria
-Have an inadequate response to MTX
Exclusion Criteria
-Have been treated with conventional synthetic disease-modifying anti-rheumatic drug, except for MTX, within 28 days prior to randomization
-Have an inadequate response to biologic disease-modifying anti-rheumatic drug or have been treated with 2 biologic treatment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>Efficacy
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>pharmacokinetics<br>Efficacy, safety, PK