BG9924 in Combination With Methotrexate for Participants With Active Rheumatoid Arthritis

Biogen

Status and phase: Terminated; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Biological: BG9924; Other: Placebo Comparator

Study type: Interventional

Funder types: Industry

Identifiers

NCT00458861

2006-005467-26 (EudraCT Number)

104RA203

Details and patient eligibility

About

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.

Enrollment: 115 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

115 participants in 2 patient groups, including a placebo group

BG9924

Experimental group

Description:

Subcutaneous administration of BG9924 given every other week for 12 weeks

Treatment:

Biological: BG9924

Placebo

Placebo Comparator group

Description:

Subcutaneous administration of placebo given every other week for 12 weeks

Treatment:

Other: Placebo Comparator