Study of the Safety of MDX-1342 in Combination With Methotrexate in Patients With Rheumatoid Arthritis
- Conditions
- Rheumatoid Arthritis
- Registration Number
- NCT00639834
- Lead Sponsor
- Bristol-Myers Squibb
- 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 patients' arthritis will also be analysed.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method incidence and severity of treatment-emergent adverse events all adverse events will be followed to resolution
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (24)
Sun Valley Arthritis Center LTD.
🇺🇸Peoria, Arizona, United States
Impact Clinical Trials
🇺🇸Los Angeles, California, United States
Centre for Rheumatology, Immunology and Arthritis (CRIA)
🇺🇸Fort Lauderdale, Florida, United States
Coastal Medical Research, Inc
🇺🇸Port Orange, Florida, United States
Lovelace Scientific Resources
🇺🇸Venice, Florida, United States
Good Samaritan Hospital and Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
Justus Fiechtner
🇺🇸Lansing, Michigan, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Altoona Center for Clinical Research
🇺🇸Duncansville, Pennsylvania, United States
Arthritis Northwest Rheumatology, PLLC
🇺🇸Spokane, Washington, United States
Scroll for more (14 remaining)Sun Valley Arthritis Center LTD.🇺🇸Peoria, Arizona, United States