At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 80 enrolled
Drug / intervention
Belimumabdrug
Likely dose
Belimumab 10 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-label, Non-randomized, 52-Week Study to Evaluate Treatment Holidays and Rebound Phenomenon After Treatment With Belimumab 10 mg/kg in Systemic Lupus Erythematosus Subjects
In Brief
A Phase 3 clinical trial evaluating Belimumab for Systemic Lupus Erythematosus. Completed, enrolled 80 participants across 20 sites in 4 countries.
Detailed Summary
This study will assess the effect of a 24-week withdrawal followed by a 28-week reintroduction of belimumab 10 mg/kg plus standard of care medications in subjects with stable low systemic lupus erythematosus (SLE) disease activity. Rebound phenomenon will be assessed for subjects who have permanently withdrawn from further belimumab treatment.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSystemic Lupus Erythematosus
CountriesChina, Japan, South Korea, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 2014
Enrollment StartMay 2014
Primary CompletionDec 2018
TodayJul 2026
First PostedApr 21, 2014
Enrollment StartMay 13, 2014
Primary CompletionDec 14, 2018
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 12.2 years ago
Interventions
Belimumabdrug
Monthly intravenous infusions dosed as 10 mg/kg body weight