Abatacept Post-marketing Clinical Study in Japa
Phase 4
- Conditions
- Rheumatoid Arthritis
- Registration Number
- JPRN-jRCT1080222075
- Lead Sponsor
- Bristol-Myers Squibb K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 400
Inclusion Criteria
MTX inadequate responder
Biologic Naive
Functional class I, II or III
6 or more swollen and 6 or more tender joints
E19-reactive protein (CRP) 2.0 or more mg/dl or erythrocyte sedimentation rate (ESR) 28 or more mm/hr
Anti-cyclic citrullinated peptide (CCP) antibody positive
E17Have erosion
Exclusion Criteria
Any other rheumatic disease
Active angiitis on main organs excluding rheumatoid nodule
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method American College of Rheumatology (ACR) 20% response rate at 4 months (week 16)<br>Change from baseline in Total Sharp Score (TSS) using the Modified van der Heijde Sharp (vdH-S) method to 6 months (Week 24)
- Secondary Outcome Measures
Name Time Method Change from baseline in Disease Activity Score-28 (DAS28)-CRP to 4 months<br>Non-progressors rate for the structural damage at 6 months (Week 24) <br>ACR 50 and 70 response rates at 4 months (Week16)<br>Safety and tolerability will be measured based on clinical Adverse Events, vital signs, and laboratory abnormalities