BG9924 in Combination With Methotrexate for Participants With Active Rheumatoid Arthritis
| Status: | Terminated |
|---|---|
| Conditions: | Arthritis, Rheumatoid Arthritis |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 4/21/2016 |
| Start Date: | March 2007 |
| End Date: | October 2008 |
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, PK, and PD of BG9924 When Given in Combo With MTX to Subjects With Active RA Who Have Had an Inadequate Response to Anti-TNF
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 inadequate response to treatment with anti-tumor necrosis factor
(anti-TNF) therapy.
subcutaneously (SC) versus placebo in participants with active rheumatoid arthritis (RA) who
have previously had an inadequate response to treatment with anti-tumor necrosis factor
(anti-TNF) therapy.
Key Inclusion Criteria:
- 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 Criteria:
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.
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