drugset / Trial / NCT01240694

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

NCT01240694 ↗

Phase 3 Terminated 136 enrolled Cephalon
NaSingle-groupOpen-labelTreatment

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).

Timeline

Start
2010-12-09
Primary completion
2012-06-14
Completion
2012-06-14

Outcome

Outcome not reported

Stopped (Business): “Business Decision; there were no safety issues”

Drugs

EvaluationDrugModalityDoseRoute
Subject FORIGERIMOD Protein / enzyme biologic 200 ug Subcutaneous