Status:
TERMINATED
BG9924 in Combination With Methotrexate for Participants With Active Rheumatoid Arthritis
Lead Sponsor:
Biogen
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This Phase 2b study is designed to evaluate the efficacy and safety of BG9924 given subcutaneously (SC) versus placebo in participants with active rheumatoid arthritis (RA) who have previously had an ...
Eligibility Criteria
Inclusion
- Key
- Diagnosis of rheumatoid arthritis (functional class I - III) at least 6 months prior to baseline
- Methotrexate (10 mg/week to 25 mg/week) \> 3 months prior to Day 0 (stable dose \> 4 weeks prior to Day 0)
- Must have had an inadequate response to anti-TNF therapy due to inadequate efficacy
- Key
Exclusion
- Medical History
- Serious local infection or systemic infection within 3 months of Day 0
- History (Hx) of recurrent infections requiring oral or parental anti-infective treatment
- Hx of tuberculosis (TB) or positive purified protein derivative (PPD) test during the screening period
- Laboratory Tests
- Clinically significant lab tests at screening; or
- Positive for hepatitis C antibody or hepatitis B at screening
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT00458861
Start Date
March 1 2007
End Date
October 1 2008
Last Update
January 21 2016
Active Locations (1)
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1
Stanford University
Palo Alto, California, United States, 93404