At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 142 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.
BEL114333, a Multicenter, Continuation Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE) Who Completed the Phase III Study BEL113750 in Northeast Asia or Completed the Open-label Extension of HGS1006-C1115 in Japan
In Brief
A Phase 3 clinical trial evaluating Belimumab for Systemic Lupus Erythematosus. Completed, enrolled 142 participants across 27 sites in 2 countries.
Detailed Summary
This study provides subjects who complete the BEL113750 study and subjects who complete the open-label extension of HGS1006-C1115 (referred to as C1115) Study in Japan the option of continuing treatment with belimumab (10 mg/kg intravenously every 4 weeks) for those randomized to belimumab, or the option to begin treatment with belimumab for those randomized to placebo, as an add-on to their standard of care SLE therapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSystemic Lupus Erythematosus
CountriesJapan, South Korea
CollaboratorsHuman Genome Sciences Inc.
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 2012
Enrollment StartJun 2012
Primary CompletionSep 2018
TodayJul 2026
First PostedMay 14, 2012
Enrollment StartJun 11, 2012
Primary CompletionSep 13, 2018
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 14.1 years ago
Interventions
Belimumabdrug
10 mg/kg administered intravenously over 1 hour every 4 weeks