At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,250 enrolled
Drug / intervention
Epratuzumab +1 moredrug
Likely dose
Epratuzumab 600 mgfrom 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.
A Phase 3, Multicenter, Open-label, Extension Study to Assess the Safety and Tolerability of Epratuzumab Treatment in Systemic Lupus Erythematosus Subjects
In Brief
A Phase 3 clinical trial evaluating Epratuzumab for Systemic Lupus Erythematosus. Completed, enrolled 1,250 participants across 228 sites in 25 countries.
Detailed Summary
The primary objective of the study is assess the safety and tolerability of long-term epratuzumab treatment in subjects with Systemic Lupus Erythematosus (SLE)
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSystemic Lupus Erythematosus
CountriesAustralia, Belgium, Brazil, Bulgaria, Canada, Czechia, Estonia, France, Germany, Hong Kong, Hungary, Israel, Italy, Lithuania, Mexico, Poland, Romania, Russia, South Africa, South Korea, Spain, Taiwan, Ukraine, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartJul 2011
First PostedAug 2011
Primary CompletionFeb 2016
TodayJul 2026
First PostedAug 3, 2011
Enrollment StartJul 1, 2011
Primary CompletionFeb 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 14.9 years ago
Interventions
Epratuzumabdrug
600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over eight 12-week treatment cycles
Epratuzumabdrug
1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over eight 12 week treatment cycles