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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


Phase 2
18 Years
75 Years
Not Enrolling
Both
Rheumatoid Arthritis

Thank you

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 UniversityStanford, California  94305