NCT01240694

A Long-Term Study of the Safety and Tolerability of Repeated Administration of CEP-33457 in Participants With Systemic Lupus Erythematosus

An Open-Label Long-Term Study of the Safety and Tolerability of Repeated Administration of CEP-33457 in Patients With Systemic Lupus Erythematosus

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 136 (actual)
• Sponsor: Cephalon, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the long term safety and tolerability of repeated administration of subcutaneous (SC) CEP-33457 for injection every 4 weeks over 72 weeks (18 doses) in participants with systemic lupus erythematosus (SLE) who have participated in a previous Cephalon sponsored clinical study of CEP-33457, and completed at least Visit 8 (Week 24 of that study).

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	CEP-33457	CEP-33457 will be administered subcutaneously per dose specified in the arm description.

Timeline

• Start date: 2010-12-09
• Primary completion: 2012-06-14
• Completion: 2012-06-14
• First posted: 2010-11-15
• Last updated: 2022-12-30
• Results posted: 2022-12-30

Locations

85 sites across 11 countries: United States, Belgium, Czechia, France, Germany, Hungary, Poland, Portugal, Spain, Ukraine, United Kingdom