BIIB023 (Anti-TWEAK) in Subjects With Rheumatoid Arthritis

Last updated: September 12, 2013
Sponsor: Biogen
Overall Status: Completed

Phase

1

Condition

Rheumatoid Arthritis

Joint Injuries

Bone Diseases

Treatment

N/A

Clinical Study ID

NCT00771329
211RA101
  • Ages 18-65
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 3months, at a stable dose for at least 4 weeks

  • Must have at least 4 swollen and tender joints due to rheumatoid arthritis

Exclusion

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

Study Design

Total Participants: 53
Study Start date:
October 01, 2008
Estimated Completion Date:
April 30, 2011

Connect with a study center

  • Research Centre

    Moscow,
    Russian Federation

    Site Not Available

  • Research Centre

    Yaroslavl,
    Russian Federation

    Site Not Available

  • Research Site

    Anniston, Alabama
    United States

    Site Not Available

  • Research Centre

    Palm Desert, California
    United States

    Site Not Available

  • Research Site

    Oklahoma City, Oklahoma
    United States

    Site Not Available

  • Research Centre

    Duncansville, Pennsylvania
    United States

    Site Not Available

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