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

This study has been terminated.
(Sponsor decision - not related to safety)
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )
ClinicalTrials.gov Identifier:
NCT00583557
First received: December 20, 2007
Last updated: October 29, 2012
Last verified: October 2012
History of Changes
  Purpose

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 Intervention Phase
Rheumatoid Arthritis
 Drug: belimumab
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • To Evaluate the Long-term Safety of LymphoStat-B™ in Subjects With RA. [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
    SEE ALSO ADVERSE EVENT (AE) RESULTS SECTION.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    NOT ANALYZED


Enrollment: 155
Study Start Date: January 2005
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Belimumab Drug: belimumab
IV 10mg/kg Q28 days
Other Name: LymphoStat-B™

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00583557

  Show 48 Study Locations
Sponsors and Collaborators
Human Genome Sciences Inc., a GSK Company
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
ClinicalTrials.gov Posting for Parent Protocol LBRA01  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )
ClinicalTrials.gov Identifier: NCT00583557     History of Changes
Other Study ID Numbers: LBRA99
Study First Received: December 20, 2007
Results First Received: April 7, 2011
Last Updated: October 29, 2012
Health Authority: United States: Food and Drug Administration
Poland: Ministry of Health

Keywords provided by GlaxoSmithKline:
Rheumatoid Arthritis
RA

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013