Pediatric Lupus Trial of Belimumab Plus Background Standard Therapy
Phase 2
Completed
NCT01649765
| Condition | Systemic Lupus Erythematosus |
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| Phase | Phase 2 |
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| Sponsor | GlaxoSmithKline |
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| Status | Completed |
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| Enrollment | 93 participants |
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| Interventions | Belimumab 10 mg/kg |
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| Start date | Sep 7, 2012 |
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| Completion date | Jan 24, 2018 |
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| Results posted | Aug 15, 2018 |
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Summary
This is a multi-center study to evaluate the safety, pharmacokinetics, and efficacy of belimumab intravenous (IV) in pediatric patients 5 to 17 years of age with active systemic lupus erythematosus
Percentage of Participants With SLE Responder Index (SRI) Response at Week 52
Week 52 · Percentage of participants
| Part A: Placebo | 43.6 Percentage of participants |
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| Part A: Belimumab 10 mg/kg | 52.8 Percentage of participants |
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| Odds Ratio (OR) | 1.49 (95% CI 0.64–3.46) |
Open in BENITIONS
View on ClinicalTrials.gov
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