BIIB023 (Anti-TWEAK) in Subjects With Rheumatoid Arthritis

Completed · Phase 1 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

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

Key facts

Study ID

NCT00771329

Run by

Biogen

People needed

53

Starts

2008-10-01

Expected to finish

2011-04-01

Last updated by the study team

2013-09-16

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Research Site — Anniston, Alabama, United States
• Research Centre — Palm Desert, California, United States
• Research Site — Oklahoma City, Oklahoma, United States
• Research Centre — Duncansville, Pennsylvania, United States
• Research Centre — Moscow, Russia
• Research Centre — Yaroslavl, Russia

Full record on ClinicalTrials.gov

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