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BIIB023 (Anti-TWEAK) in Subjects With Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00771329
Recruitment Status : Completed
First Posted : October 13, 2008
Last Update Posted : September 16, 2013
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Brief 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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: BIIB023 Other: Placebo (sterile normal saline) Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BIIB023 (Anti-TWEAK) Administered to Subjects With Rheumatoid Arthritis.
Study Start Date : October 2008
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Drug: BIIB023
Single IV doses of BIIB023 in dose-escalating cohorts
Other Name: Human glycosylated IgG1 monoclonal antibody

Placebo Comparator: 2 Other: Placebo (sterile normal saline)
Single IV dose of Placebo

Primary Outcome Measures :
  1. Determine the safety and tolerability of single doses of BIIB023 administered intravenously (IV) to subjects with RA. [ Time Frame: Baseline through Day 70 ]

Secondary Outcome Measures :
  1. • Estimate the pharmacokinetic (PK) parameters of single doses of BIIB023 administered IV to subjects with RA • Evaluate potential markers of pharmacodynamic (PD) action of BIIB023 and its biological effects [ Time Frame: Day -1, 0 (at several timepoints), 1, 2, 7, 14, 21, 28, 42, 56 and Day 70 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00771329

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United States, Alabama
Research Site
Anniston, Alabama, United States
United States, California
Research Centre
Palm Desert, California, United States
United States, Oklahoma
Research Site
Oklahoma City, Oklahoma, United States
United States, Pennsylvania
Research Centre
Duncansville, Pennsylvania, United States
Russian Federation
Research Centre
Moscow, Russian Federation
Research Centre
Yaroslavl, Russian Federation
Sponsors and Collaborators
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Medical Director, Biogen Idec Identifier: NCT00771329    
Other Study ID Numbers: 211RA101
First Posted: October 13, 2008    Key Record Dates
Last Update Posted: September 16, 2013
Last Verified: May 2011
Additional relevant MeSH terms:
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Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs