[M20-466] Moderate to Severe Rheumatoid Arthritis: A Phase 2b, Dose-Ranging, Safety and Efficacy Study of ABBV-154
Phase 2
Suspended
- Conditions
- Rheumatiod Arthritis
- Registration Number
- JPRN-jRCT2041210052
- Lead Sponsor
- Yamazaki Hayato
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- All
- Target Recruitment
- 425
Inclusion Criteria
Clinical diagnosis of rheumatoid arthritis(RA) with fulfillment of the 2010 ACR/European League Against Rheumatism (EULAR) classification criteria for RA.
--Participant has 6 swollen joints (based on 66 joint count) and 6 tender joints (based on 68 joint count) at baseline.
--Participant must have had an inadequate response to at least one prior biologic and/or targeted synthetic disease-modifying anti-rheumatic drugs (b/tsDMARDs) treatment for RA.
--Participants must be on stable dose of methotrexate (MTX).
Exclusion Criteria
--Participant discontinued prior adalimumab therapy due to intolerability or toxicity.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of Participants Achieving American College of Rheumatology 50 % (ACR50) Response [ Time Frame: At 12 weeks ]
- Secondary Outcome Measures
Name Time Method