Status:
COMPLETED
BIIB023 (Anti-TWEAK) in Subjects With Rheumatoid Arthritis
Lead Sponsor:
Biogen
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
Phase I study designed to determine the safety and tolerability of a single dose of BIIB023 administered intravenously versus placebo to subjects with RA.
Eligibility Criteria
Inclusion
- Diagnosis of adult onset RA (functional class I-III) for at least 6 months
- Must have been treated with and be tolerating Methotrexate (5-25 mg/week) for 3 months, at a stable dose for at least 4 weeks
- Must have at least 4 swollen and tender joints due to rheumatoid arthritis
Exclusion
- History of recurrent infections requiring antibiotic treatment within 12 months
- Serious local infection or systemic infection within 3 months
- Suffering from rheumatic or autoimmune disease other than RA
- History of cancer, heart failure, kidney disease, liver disease, HIV infection, tuberculosis or other serious illness
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT00771329
Start Date
October 1 2008
End Date
April 1 2011
Last Update
September 16 2013
Active Locations (6)
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1
Research Site
Anniston, Alabama, United States
2
Research Centre
Palm Desert, California, United States
3
Research Site
Oklahoma City, Oklahoma, United States
4
Research Centre
Duncansville, Pennsylvania, United States