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Sponsors and Collaborators: |
Human Genome Sciences GlaxoSmithKline |
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Information provided by: | Human Genome Sciences |
ClinicalTrials.gov Identifier: | NCT00424476 |
The purpose of this study is to evaluate the efficacy, safety, tolerability, and impact on quality of life of two different doses of belimumab administered in addition to standard therapy in subjects with active SLE disease.
Condition | Intervention | Phase |
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Systemic Lupus Erythematosus |
Drug: belimumab Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Wk Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects With Systemic Lupus Erythematosus (SLE) |
Estimated Enrollment: | 810 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
1mg/kg
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Drug: belimumab
1mg/kg, IV (in the vein) on Days 0, 14, 28, and every 28 days through 48 weeks with a final evaluation at Week 52
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2: Experimental
10mg/kg
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Drug: belimumab
10mg/kg, IV (in the vein) on Days 0, 14, 28 and every 28 days through 48 weeks with a final evaluation at Week 52
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3: Placebo Comparator
Placebo
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Drug: Placebo
IV (in the vein) on Days 0, 14, 28, and every 28 days through 52 weeks
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The purpose of this SLE trial study is to evaluate the efficacy, safety, tolerability, and impact on quality of life of two different doses of belimumab administered in addition to standard therapy in subjects with active Systemic Lupus Erythematosus (SLE) disease.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
Key Exclusion Criteria:
Study Director: | William Freimuth, MD, PhD | Human Genome Sciences, Inc. |
Responsible Party: | Human Genome Sciences, Inc. ( William Freimuth, MD, PhD/Vice President of Clinical Research, Immunology, Rheumatology and Infectious Diseases ) |
Study ID Numbers: | HGS1006-C1057, BLISS-52 |
Study First Received: | January 17, 2007 |
Last Updated: | February 17, 2009 |
ClinicalTrials.gov Identifier: | NCT00424476 History of Changes |
Health Authority: | United States: Food and Drug Administration; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Brazil: Ministry of Health; Chile: Instituto de Salud Publica de Chile; India: Ministry of Health; Romania: Ministry of Public Health; Korea: Food and Drug Administration; Taiwan: Department of Health; Philippines: Department of Health; Australia: National Health and Medical Research Council; Hong Kong: Department of Health; Russia: Ministry of Health and Social Development of the Russian Federation; Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos; Peru: General Directorate of Pharmaceuticals, Devices, and Drugs |
SLE Lupus Systemic Lupus Erythematosus |
Antibodies Autoimmune Diseases Belimumab |
Antibodies Autoimmune Diseases Lupus Erythematosus, Systemic |
Lupus Connective Tissue Diseases Immunoglobulins |
Autoimmune Diseases Immune System Diseases Lupus Erythematosus, Systemic Connective Tissue Diseases |