Status:
COMPLETED
Study of the Safety of MDX-1342 in Combination With Methotrexate in Patients With Rheumatoid Arthritis
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine if MDX-1342 given in combination with Methotrexate is a safe treatment for patients with active rheumatoid arthritis. In addition, changes in the severity pat...
Eligibility Criteria
Inclusion
- Must have met ACR criteria for the diagnosis of rheumatoid arthritis (RA)
- Must have active RA
- Must be treated with Methotrexate (MTX) (10 to 25 mg weekly) for at least 3 months and have received a stable dose for at least 28 days prior to the anticipated study drug administration date.
- All other DMARDs or biologics must be discontinued at least 28 days prior to study drug administration and: 1) Leflunomide, which must be discontinued at least 60 days before study drug administration, 2) infliximab, adalimumab, and abatacept must be discontinued at least 56 days prior to study drug administration
Exclusion
- Both Rheumatoid factor and anti-CCP negative
- Prior treatment with any B-cell depleting therapy
- Any other mAb or Ig-based fusion proteins 56 days or less prior to Visit
- History of or current inflammatory joint disease other than RA
- Neuropathies or neurovasculopathies that might interfere with pain evaluation
- Complications of RA or other disease
- Any other autoimmune disease other than RA
- Acute or chronic infection
- Clinically significant disease requiring
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00639834
Start Date
February 1 2008
End Date
June 1 2010
Last Update
May 22 2013
Active Locations (24)
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1
Sun Valley Arthritis Center LTD.
Peoria, Arizona, United States, 85381
2
Impact Clinical Trials
Los Angeles, California, United States, 90036
3
Centre for Rheumatology, Immunology and Arthritis (CRIA)
Fort Lauderdale, Florida, United States, 33334
4
Coastal Medical Research, Inc
Port Orange, Florida, United States, 32127