A Continuation Trial for Subjects With Rheumatoid Arthritis That Have Completed Protocol LBRA01

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: NCT00583557
Recruitment Status : Terminated (Sponsor decision - not related to safety)
First Posted : December 31, 2007
Results First Posted : June 29, 2011
Last Update Posted : August 7, 2013
Information provided by (Responsible Party):
Human Genome Sciences Inc.

Brief Summary:
This is a continuation trial of LymphoStat-B™ to evaluate the long-term safety in subjects with Rheumatoid Arthritis that completed study LBRA01 and benefitted from treatment.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: belimumab Phase 2

Detailed Description:
This is a multi-center, open label, continuation trial of LymphoStat-B™ in Rheumatoid Arthritis (RA) subjects who achieved at least an ACR20 response in the Phase 2 study LBRA01 (NCT00071812).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 155 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-Center, Open-Label, Continuation Trial of LymphoStat-B™ Antibody (Monoclonal Anti-BLyS Antibody) in Subjects With Rheumatoid Arthritis (RA) Who Completed the Phase 2 Protocol LBRA01
Study Start Date : January 2005
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Belimumab
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Belimumab Drug: belimumab
IV 10mg/kg Q28 days
Other Name: LymphoStat-B™

Primary Outcome Measures :
  1. To Evaluate the Long-term Safety of LymphoStat-B™ in Subjects With RA. [ Time Frame: Up to 5 years ]

Secondary Outcome Measures :
  1. The Efficacy Endpoints Will Include Long-term ACR Responses, DAS28 Response, C-reactive Protein (CRP), Erythrocyte Sedimentation Rate (ESR), and Rheumatoid Factor (RF). [ Time Frame: up to 5 Years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Primary Inclusion Criteria:

  1. Have completed the LBRA01 trial.
  2. Have achieved at least an ACR20 response at the end of LBRA01.

Primary Exclusion Criteria:

  1. Have switched NSAIDs due to worsening RA disease activity, used more than 10 mg/day of oral prednisone, or were given a corticosteroid injection during the last 30 days of LBRA01.
  2. Required a new DMARD (not otherwise excluded in protocol LBRA01) to replace an ineffective one, or an additional DMARD (not to exceed 2 DMARDs in total) within the last 60 days of LBRA01.
  3. Used prohibited medications during their participation in LBRA01. These medications include the following:

    • Other investigational agents.
    • Biologic response modifiers
    • Cyclophosphamide.
    • Corticosteroid injections (except 1 injection of up to 40 mg of prednisone into an inflamed joint or intramuscularly every 6 months).
    • 2 new DMARDs.
    • 1 new DMARD plus high dose prednisone >10 mg/day.

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): NCT00583557

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Sponsors and Collaborators
Human Genome Sciences Inc.
Study Director: GSK Clinical Trials GlaxoSmithKline

Additional Information:
Responsible Party: Human Genome Sciences Inc. Identifier: NCT00583557     History of Changes
Other Study ID Numbers: LBRA99
First Posted: December 31, 2007    Key Record Dates
Results First Posted: June 29, 2011
Last Update Posted: August 7, 2013
Last Verified: August 2013

Keywords provided by Human Genome Sciences Inc.:
Rheumatoid Arthritis

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs