Status:
COMPLETED
A Phase IIIb Study of BMS-188667 in Subjects With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Active Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The only trial in participants who are methotrexate-inadequate responders and have active Rheumatoid Arthritis, in which gadolinium-enhanced Magnetic Resonance Imaging; Bone Mineral Density; and bioch...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Disease activity as defined by a Disease Activity Score 28-C-Reactive Protein (CRP) \>3.2 or \>6 swollen and ≥6 tender joints and CRP greater than the upper limit of normal
- At least 1 erosion in hands/wrists or positive anticyclic citrullinated peptides or rheumatoid factor
- Clinically detectable synovitis of at least 1 wrist/ankle at screening and baseline
- Participants must have been treated with methotrexate, on a weekly dose of at least 15 mg or a maximum tolerated dose (such as, 10 mg weekly) for at least 3 months before screening. Dose of methotrexate must be stable for at least 28 days prior to the first study dose (Day 1)
Exclusion
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00420199
Start Date
May 1 2007
End Date
May 1 2010
Last Update
January 18 2012
Active Locations (10)
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1
Local Institution
Brussels, Belgium, 1200
2
Local Institution
Yvoir, Belgium, 5530
3
Local Institution
Berlin, Germany, 14059
4
Local Institution
Berlin, Germany, BE-10117