A Phase IIIb Study of BMS-188667 in Subjects With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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 biochemical markers of bone, cartilage, and synovial tissue metabolism are used to evaluate early effects (4 months) of Abatacept on inflammation/structural damage. Study will provide valuable mechanism-of-action information on how Abatacept exerts its effects (including on bone) through new techniques.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
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)
Trial design
Primary purpose
Allocation
Interventional model
Masking
50 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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