A Continuation Trial for Subjects With Systemic Lupus Erythematosus That Have Completed Protocol LBSL02
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )
First received: December 20, 2007
Last updated: November 7, 2013
Last verified: November 2013
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.
Systemic Lupus Erythematosus
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
Primary Outcome Measures:
- To evaluate the long-term safety of LymphoStat-B™ in subjects with SLE. [ Time Frame: Until study completion ] [ Designated as safety issue: Yes ]
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||May 2016 (Final data collection date for primary outcome measure)
Experimental: Belimumab 10 mg/kg
Belimumab 10 mg/kg IV over one hour every 28 days.
Belimumab 10mg/kg IV over one hour every 28 days
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Primary Inclusion Criteria
1. Have completed the LBSL02 trial and achieved a satisfactory response.
Primary Exclusion Criteria
- Required more than 2 courses of corticosteroids for treatment of severe SLE flares in the last 5 months of LBSL02.
- Had an SLE flare during the last 30 days of LBSL02 and through the 1st dose in LBSL99.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00583362
Human Genome Sciences Inc., a GSK Company
||GSK Clinical Trials
No publications provided by GlaxoSmithKline
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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.
||GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 20, 2007
||November 7, 2013
||United States: Food and Drug Administration
Canada: Health Canada
Keywords provided by GlaxoSmithKline:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 11, 2014
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Immune System Diseases