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A Continuation Trial for Subjects With Lupus Who Completed Protocol HGS1006-C1056 in the United States

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )
ClinicalTrials.gov Identifier:
NCT00724867
First received: July 28, 2008
Last updated: June 6, 2013
Last verified: December 2012
History of Changes

July 28, 2008
June 6, 2013
August 2008
February 2010   (final data collection date for primary outcome measure)
To evaluate the long term safety of belimumab (LymphoStat-B™) in subjects with SLE [ Time Frame: Until study completion ] [ Designated as safety issue: Yes ]
  • To evaluate the long-term safety of belimumab (LymphoStat-B™) in subjects with SLE [ Time Frame: Until the drug is approved ] [ Designated as safety issue: Yes ]
  • At Wk52, the percent of subjects with ≥ 4 point reduction from baseline in SELENA SLEDAI score and no worsening in PGA and no new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with baseline at the time of assessment. [ Time Frame: every 6 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00724867 on ClinicalTrials.gov Archive Site
  • Assessment of efficacy and biomarkers including: disease activity, anti-dsDNA and serum complement levels, prednisone use, proteinuria level, serum immunoglobulin G, and B-cell subsets. [ Time Frame: Until study completion ] [ Designated as safety issue: No ]
  • Assessment of quality of life according to the following scales: SF-36 Health Survey, and FACIT-Fatigue scale. [ Time Frame: Until study completion ] [ Designated as safety issue: No ]
  • Assessment of efficacy according to the SLICC/ACR Damage Index. [ Time Frame: Until study completion ] [ Designated as safety issue: No ]
  • Assessment of efficacy and biomarkers including: disease activity, anti-dsDNA and serum complement levels, prednisone use, proteinuria level, serum immunoglobulin G, and B-cell subsets. [ Time Frame: every 6 months ] [ Designated as safety issue: No ]
  • Assessment of quality of life according to the following scales: SF-36 Health Survey, and FACIT-Fatigue scale. [ Time Frame: every 48 weeks ] [ Designated as safety issue: No ]
  • Assessment of efficacy according to the SLICC/ACR Damage Index. [ Time Frame: every 48 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Continuation Trial for Subjects With Lupus Who Completed Protocol HGS1006-C1056 in the United States
A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects With Systemic Lupus Erythematosus (SLE) Who Completed the Phase 3 Protocol HGS1006-C1056 in the United States

This is a continuation study to provide continuing treatment to subjects who completed study HGS1006-C1056 in the United States, to evaluate the long-term safety and efficacy of belimumab(LymphoStat-B™) in subjects with SLE disease.

This is a long-term continuation study to provide continuing treatment to subjects who completed study HGS1006-C1056 in the United States. This study is to evaluate the long-term safety and efficacy of belimumab (LymphoStat-B™) in subjects with SLE disease.
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Systemic Lupus Erythematosus
  • Biological: Belimumab 1 mg/kg
    Belimumab 1 mg/kg IV over one hour every 28 days
    Other Names:
    • BENLYSTA
    • HGS1006
    • LymphoStat-B™
  • Biological: Belimumab 10 mg/kg
    Belimumab 10 mg/kg IV over one hour every 28 days
    Other Names:
    • LymphoStat-B™
    • BENLYSTA
    • HGS1006
  • Experimental: Belimumab 1 mg/kg
    Belimumab 1 mg/kg IV every 28 days
    Intervention: Biological: Belimumab 1 mg/kg
  • Experimental: Belimumab 10 mg/kg
    Belimumab 10 mg/kg IV every 28 days
    Intervention: Biological: Belimumab 10 mg/kg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
268
May 2015
February 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Have completed the HGS1006-C1056 protocol in the United States through Week 72 visit.
  • Be able to receive 1st dose of belimumab for HGS 1006-c1066 four weeks after last dose in HGS1006-c1056.

Exclusion Criteria:

  • Have developed any other medical disease or condition that has made the subject unsuitable for this study in the opinion of their physician.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00724867
112233, HGS1006-C1066
Yes
GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )
Human Genome Sciences Inc., a GSK Company
GlaxoSmithKline
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