NCT01408576

Open Label Extension Study of Epratuzumab in Subjects With Systemic Lupus Erythematosus

A Phase 3, Multicenter, Open-label, Extension Study to Assess the Safety and Tolerability of Epratuzumab Treatment in Systemic Lupus Erythematosus Subjects

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,250 (actual)
• Sponsor: UCB Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Detailed description

Treatment period was extended by 2 years to a total of 4 years and an amendment was prepared accordingly.

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	Epratuzumab	600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over eight 12-week treatment cycles
DRUG	Epratuzumab	1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over eight 12 week treatment cycles

Timeline

• Start date: 2011-07-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2011-08-03
• Last updated: 2018-10-03
• Results posted: 2018-10-03

Locations

228 sites across 25 countries: United States, Australia, 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