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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

December 20, 2007
October 29, 2012
January 2005
November 2009   (final data collection date for primary outcome measure)
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.
To evaluate the long-term safety of LymphoStat-B™ in subjects with RA. [ Time Frame: Until the drug is approved ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00583557 on ClinicalTrials.gov Archive Site
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
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: Until the drug is approved. ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Continuation Trial for Subjects With Rheumatoid Arthritis That Have Completed Protocol LBRA01
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

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.

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).
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Rheumatoid Arthritis
Drug: belimumab
IV 10mg/kg Q28 days
Other Name: LymphoStat-B™
Experimental: Belimumab
Intervention: Drug: belimumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
155
November 2009
November 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Poland
 
NCT00583557
LBRA99
Yes
GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )
Human Genome Sciences Inc., a GSK Company
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP