Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to evaluate the safety and efficacy of 3 different doses of belimumab, administered in addition to standard therapy, in patients with active SLE disease.


Clinical Trial Description

The purpose of this study is to evaluate the safety and efficacy of three different doses of belimumab (1 mg/kg, 4 mg/kg, and 10 mg/kg), administered in addition to standard therapy, compared to placebo plus standard therapy in patients with active SLE disease. Patients were randomly assigned, following stratification by the screening SELENA SLEDAI score (4 to 7 versus ≥ 8), to 1 of the 4 study arms (3 active arms and 1 placebo arm plus standard therapy for SLE). All patients were to be dosed on Days 0, 14, and 28, then every 28 days for the remainder of 52 weeks. Patients completing the 52-week period could enter a 24-week open-label extension; belimumab patients received the same dose or were switched to 10 mg/kg at the investigator's discretion and former placebo patients received belimumab 10 mg/kg. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00071487
Study type Interventional
Source Human Genome Sciences Inc.
Contact
Status Completed
Phase Phase 2
Start date October 2003
Completion date June 2006

See also
  Status Clinical Trial Phase
Completed NCT03248518 - Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases N/A
Recruiting NCT05967520 - JMKX000189 for Moderate to Severe Active Systemic Lupus Erythematosus Phase 2
Completed NCT02875691 - Effect of Green Tea on Treatment of Lupus Phase 2
Completed NCT02922114 - Comparison of the Clinical Examination and the Joint Ultrasonography in Lupus Patients N/A
Withdrawn NCT01702038 - Determining the Responses and Impact of Rituximab-instigated Cell Depletion on T Cells in People With SLE Phase 2
Terminated NCT00368264 - TNF Blockade With Remicade in Active Lupus Nephritis WHO Class V (TRIAL ) Phase 2/Phase 3
Completed NCT00094380 - Treating Systemic Lupus Erythematosus (SLE) Patients With CTLA4-IgG4m (RG2077) Phase 1/Phase 2
Completed NCT00065806 - Atherosclerosis Prevention in Pediatric Lupus Erythematosus (APPLE) Phase 3
Completed NCT00005436 - Lupus Cohort--Thrombotic Events and Coronary Artery Disease N/A
Recruiting NCT03543839 - Trial of Belimumab in Early Lupus Phase 4
Completed NCT03098823 - A Crossover Study to Compare RAYOS to IR Prednisone to Improve Fatigue and Morning Symptoms for SLE Phase 4
Recruiting NCT05899907 - Efficacy and Safety of Telitacicept in Early SLE Phase 4
Completed NCT04956484 - Belimumab In Early Systemic Lupus Erythematosus Phase 4
Completed NCT05326841 - Effect of Cholecalciferol Supplementation on Disease Activity and Quality of Life of Systemic Lupus Erythematosus Patients . Phase 3
Completed NCT02655640 - The Impact of Illness Perceptions on Health Related Outcomes in Patients With Lupus and Systemic Sclerosis N/A
Completed NCT02034344 - A Study of Skin and Systemic Biomarkers In Patients With Active Cutaneous Lupus Erythematosus And In Healthy Volunteers Phase 0
Terminated NCT00089804 - Study of LJP 394 in Lupus Patients With History of Renal Disease Phase 3
Completed NCT02349061 - A Phase 2a, Efficacy and Safety Study of Ustekinumab in Systemic Lupus Erythematosus Phase 2
Recruiting NCT05636670 - Assessment of Cognitive Function and Gut Microbiota Analysis in Real World Patients With Lupus Cerebrovascular Disease
Recruiting NCT03747159 - Synergetic B-cell Immunomodulation in SLE - 2nd Study. Phase 3