Pediatric Lupus Trial of Belimumab Plus Background Standard Therapy

Фаза 2 Завершено NCT01649765

Заболевание	Systemic Lupus Erythematosus
Фаза	Фаза 2
Спонсор	GlaxoSmithKline
Статус	Завершено
Участники	93 участн.
Вмешательство	Belimumab 10 mg/kg
Дата начала	7.09.2012
Дата завершения	24.01.2018
Публикация результатов	15.08.2018

Кратко

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
Part A: Belimumab 10 mg/kg	52.8 Percentage of participants

Odds Ratio (OR)	1.49 (95% CI 0.64–3.46)

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Все исследования

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