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
18 Years
75 Years
Both
Rheumatoid Arthritis
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Evaluate efficacy of BG9924 in combination with methotrexate in RA patients who have had an inadequate response to anti-TNF therapy
Outcome Time Frame:
26 weeks
Safety Issue:
No
Principal Investigator
Biogen Idec Medical Director
Investigator Role:
Study Director
Investigator Affiliation:
Biogen Idec, Cambridge, MA USA
Authority:
United States: Food and Drug Administration
Study ID:
104RA203
NCT ID:
NCT00458861
Start Date:
March 2007
Completion Date:
October 2008
Related Keywords:
- Rheumatoid Arthritis
- Active Rheumatoid Arthritis (RA)
- Arthritis
- Arthritis, Rheumatoid
Name | Location |
|---|---|
| Stanford University | Stanford, California 94305 |
