Phase 2 Study of Belimumab Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus (SLE)
NCT ID: NCT00732940
Last Updated: 2013-08-07
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
56 participants
INTERVENTIONAL
2008-10-31
2012-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Belimumab Q2WKS
Every other week: 100 mg of belimumab (1 injection) subcutaneous (under the skin) on days 0, 7, and 14, then every other week until final evaluation at Week 24 with option to continue receiving belimumab at the same dose through 144 week continuation period.
Belimumab 100 mg SC
Belimumab 100 mg SC for 1 injection on Days 0, 7, 14, and then every two weeks.
Belimumab 3X/WK
Three times weekly: 200 mg of belimumab (2 injections of 100 mg each) subcutaneous (under the skin) on days 0, 2, and 4 then 100 mg three times a week until final evaluation at Week 24 with option to continue receiving belimumab at the same dose through 144 week continuation period.
Belimumab 100 mg SC
Belimumab 100mg SC for 2 injections (of 100mg each) on Days 0, 2, and 4, then 100 mg (1 injection) three times per week.
Interventions
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Belimumab 100 mg SC
Belimumab 100 mg SC for 1 injection on Days 0, 7, 14, and then every two weeks.
Belimumab 100 mg SC
Belimumab 100mg SC for 2 injections (of 100mg each) on Days 0, 2, and 4, then 100 mg (1 injection) three times per week.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Active SLE disease
* On stable SLE treatment regimen
Exclusion Criteria
* Have received treatment with an B cell targeted therapy
* Have received treatment with a biologic investigational agent in the past year
* Have received intravenous (IV) cyclophosphamide within 180 days of Day 0
* Have severe lupus kidney disease
* Have active central nervous system (CNS) lupus
* Have required management of acute or chronic infections with the past 60 days
* Have current drug or alcohol abuse or dependence or within the past year
* Have a historically positive test or test positive at screening for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
* Have a history of an allergic or anaphylactic reaction to drugs, food, or insects requiring medical intervention
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Human Genome Sciences Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Valerious Medical Group Research Center
Long Beach, California, United States
Tampa Medical Group, PA
Tampa, Florida, United States
Fiechtner Research, Inc.
Lansing, Michigan, United States
SUNY Downstate Medical Center
Brooklyn, New York, United States
North Shore-LIJ Health System/Rheumatology, Allergy, Immunology
Lake Success, New York, United States
Rheumatology Associates
Smithtown, New York, United States
STAT Research, Inc.
Dayton, Ohio, United States
Oklahoma Center for Arthritis Therapy & Research
Tulsa, Oklahoma, United States
Houston Institute for Clinical Research
Houston, Texas, United States
Hospital Central "Igancio Morones Prieto"
San Lusi Potosi, , Mexico
Countries
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References
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van Vollenhoven RF, Navarra SV, Levy RA, Thomas M, Heath A, Lustine T, Adamkovic A, Fettiplace J, Wang ML, Ji B, Roth D. Long-term safety and limited organ damage in patients with systemic lupus erythematosus treated with belimumab: a Phase III study extension. Rheumatology (Oxford). 2020 Feb 1;59(2):281-291. doi: 10.1093/rheumatology/kez279.
Other Identifiers
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112232
Identifier Type: OTHER
Identifier Source: secondary_id
HGS1006-1070
Identifier Type: -
Identifier Source: org_study_id