BIIB023 (Anti-TWEAK) in Subjects With Rheumatoid Arthritis

Biogen

Status and phase: Completed; Phase 1

Conditions: Rheumatoid Arthritis

Treatments: Other: Placebo (sterile normal saline); Drug: BIIB023

Study type: Interventional

Funder types: Industry

Identifiers

NCT00771329

211RA101

Details and patient eligibility

About

Phase I study designed to determine the safety and tolerability of a single dose of BIIB023 administered intravenously versus placebo to subjects with RA.

Enrollment: 53 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of adult onset RA (functional class I-III) for at least 6 months
• Must have been treated with and be tolerating Methotrexate (5-25 mg/week) for 3 months, at a stable dose for at least 4 weeks
• Must have at least 4 swollen and tender joints due to rheumatoid arthritis

Exclusion criteria

• History of recurrent infections requiring antibiotic treatment within 12 months
• Serious local infection or systemic infection within 3 months
• Suffering from rheumatic or autoimmune disease other than RA
• History of cancer, heart failure, kidney disease, liver disease, HIV infection, tuberculosis or other serious illness

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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53 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

BIIB023

Treatment:

Drug: BIIB023

2

Placebo Comparator group

Treatment:

Other: Placebo (sterile normal saline)