Phase 2 Study of Belimumab Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus (SLE)
NCT00732940 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 56
Last updated 2013-08-07
Summary
The purpose of this study is to test the safety and tolerability of repeated subcutaneous (SC) doses of belimumab in subjects with SLE.
Conditions
Interventions
- DRUG
-
Belimumab 100 mg SC
Belimumab 100 mg SC for 1 injection on Days 0, 7, 14, and then every two weeks.
- DRUG
-
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.
Sponsors & Collaborators
- collaborator INDUSTRY
-
Human Genome Sciences Inc.
lead INDUSTRY
Principal Investigators
-
GSK Clinical Trials · GlaxoSmithKline
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-10-31
- Primary Completion
- 2009-10-31
- Completion
- 2012-03-31
Countries
- United States
- Mexico
Study Locations
More Related Trials
-
A Study of Belimumab Administered Subcutaneously in Subjects With Systemic Lupus Erythematosus (SLE)
NCT01484496 ·Status: COMPLETED ·Phase: PHASE3
-
A Continuation Trial for Subjects With Systemic Lupus Erythematosus That Have Completed Protocol LBSL02
NCT00583362 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE)
NCT00424476 ·Status: COMPLETED ·Phase: PHASE3
-
A Study Describing the Efficacy and Safety of Belimumab Administered in Adult Participants With Early Systemic Lupus Erythematosus (SLE)
NCT06411249 ·Status: RECRUITING ·Phase: PHASE4
-
A Study to Evaluate the Effect of Belimumab on Vaccine Responses in Subjects With Systemic Lupus Erythematosus (SLE)
NCT01597492 ·Status: COMPLETED ·Phase: PHASE4
-
A Phase 2B Open-Label, Single-Arm, Repeat-Dose Study to Evaluate the Reliability of an Autoinjector
NCT02124798 ·Status: COMPLETED ·Phase: PHASE2
-
Belimumab Assessment of Safety in SLE
NCT01705977 ·Status: COMPLETED ·Phase: PHASE4
-
Evaluation of Belimumab Impact on a BLyS Activity Signature Test in the Absence of Confounding Polypharmacy
NCT02270970 ·Status: UNKNOWN ·Phase: PHASE4
-
Efficacy and Safety of Belimumab in Black Race Patients With Systemic Lupus Erythematosus (SLE)
NCT01632241 ·Status: COMPLETED ·Phase: PHASE4
-
A Pooled Analysis of the HGS1006-C1056 (BLISS-52) and HGS1006-C1057 (BLISS-76) Studies
NCT01858792 ·Status: COMPLETED
-
GSK1550188 A 52 Week Study of Belimumab Versus Placebo in the Treatment of Subjects With Systemic Lupus Erythematosus (SLE) Located in Northeast Asia
NCT01345253 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety of Belimumab in Patients With Active Lupus Nephritis
NCT01639339 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination With Rituximab to Adult Subjects With Systemic Lupus Erythematosus (SLE) - BLISS-BELIEVE
NCT03312907 ·Status: COMPLETED ·Phase: PHASE3
-
Effectiveness of Belimumab Treatment in a Subpopulation of Systemic Lupus Erythematosus (SLE) Patients: a Pooled Analysis of BLISS-52 and BLISS-76
NCT01914770 ·Status: COMPLETED
-
A Study to Estimate the Relative Bioavailability, Tolerability and Safety of a Single Dose of Belimumab Self-Administered Subcutaneously (SC) by Healthy Subjects
NCT01894360 ·Status: COMPLETED ·Phase: PHASE1
-
Transcriptional and Immune Parameters of Response to Belimumab
NCT04570306 ·Status: COMPLETED
-
Study of Subcutaneous (SC) Belimumab in Pediatric Participants With Systemic Lupus Erythematosus (SLE)
NCT04179032 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
A Study of LY2127399 in Participants With Systemic Lupus Erythematosus
NCT01205438 ·Status: COMPLETED ·Phase: PHASE3
-
Compassionate Use for Subcutaneous (SC) Belimumab
NCT03125486 ·Status: NO_LONGER_AVAILABLE
-
A Phase 2a, Efficacy and Safety Study of Ustekinumab in Systemic Lupus Erythematosus
NCT02349061 ·Status: COMPLETED ·Phase: PHASE2
-
Sequential Belimumab and T-cell Based Therapy in SLE
NCT04447053 ·Status: UNKNOWN ·Phase: PHASE4
-
Safety and Effectiveness of BENLYSTA (Belimumab) in Systemic Lupus Erythematosus (SLE) Registry
NCT01729455 ·Status: COMPLETED
-
A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus Erythematosus
NCT00137969 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Belimumab in SLE Synovial Inflammation and Lymph Nodes
NCT06327724 ·Status: RECRUITING
-
Determining the Responses and Impact of Rituximab-instigated Cell Depletion on T Cells in People With SLE
NCT01702038 ·Status: WITHDRAWN ·Phase: PHASE2