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A Continuation Trial for Subjects With Systemic Lupus Erythematosus That Have Completed Protocol LBSL02

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00583362
First received: December 20, 2007
Last updated: December 13, 2012
Last verified: December 2012
History of Changes

December 20, 2007
December 13, 2012
November 2004
September 2005   (final data collection date for primary outcome measure)
To evaluate the long-term safety of LymphoStat-B™ in subjects with SLE. [ Time Frame: Until study completion ] [ Designated as safety issue: Yes ]
To evaluate the long-term safety of LymphoStat-B™ in subjects with SLE. [ Time Frame: Until the drug is approved ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00583362 on ClinicalTrials.gov Archive Site
Not Provided
The efficacy endpoints will include time-to-flare SELENA SLEDAI, PGA, BILAG, reduction in steroid use, biological markers and autoantibodies. [ Time Frame: Until the drug is approved. ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Continuation Trial for Subjects With Systemic Lupus Erythematosus That Have Completed Protocol LBSL02
A Multi-Center, Open-Label, Continuation Trial LymphoStat-B™ Antibody (Monoclonal Anti-BLyS Antibody) in Subjects With Systemic Lupus Erythematosus (SLE) Who Completed the Phase 2 Protocol LBSL02

This is a continuation study to evaluate the long-term safety and efficacy of LymphoStat-B™ in subjects with SLE disease, that completed study LBSL02 and benefitted from treatment.

The purpose of this continuation study to evaluate the long-term safety and efficacy of LymphoStat-B™ in subjects with Systemic Lupus Erythematosus (SLE), that completed study LBSL02 and benefitted from treatment.
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Systemic Lupus Erythematosus
Biological: Belimumab
Belimumab 10mg/kg IV over one hour every 28 days
Other Names:
  • HGS1006
  • BENLYSTA
  • LymphoStat-B™
Experimental: Belimumab 10 mg/kg
Belimumab 10 mg/kg IV over one hour every 28 days.
Intervention: Biological: Belimumab
Merrill JT, Ginzler EM, Wallace DJ, McKay JD, Lisse JR, Aranow C, Wellborne FR, Burnette M, Condemi J, Zhong ZJ, Pineda L, Klein J, Freimuth WW; LBSL02/99 Study Group. Long-term safety profile of belimumab plus standard therapy in patients with systemic lupus erythematosus. Arthritis Rheum. 2012 Oct;64(10):3364-73. doi: 10.1002/art.34564.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
298
May 2016
September 2005   (final data collection date for primary outcome measure)

Primary Inclusion Criteria

1. Have completed the LBSL02 trial and achieved a satisfactory response.

Primary Exclusion Criteria

  1. Required more than 2 courses of corticosteroids for treatment of severe SLE flares in the last 5 months of LBSL02.
  2. Had an SLE flare during the last 30 days of LBSL02 and through the 1st dose in LBSL99.

  3. Used any of the following prohibited medications during their participation in LBSL02:

    • Other investigational agents.
    • Biologic therapeutic agents: adalimumab (Humira™), etanercept (Enbrel™), infliximab (Remicade™), and rituximab (Rituxan™).
    • Intravenous cyclophosphamide.
    • Corticosteroids >100 mg/day prednisone equivalent for reasons other than severe SLE flare.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00583362
112626, LBSL99
Yes
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
December 2012

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