NCT01305746

A Trial for Subjects With Systemic Lupus Erythematosus Who Have Completed Protocol AN-SLE3321

An Open-Label Long-term Safety Extension Trial for Subjects With Systemic Lupus Erythematosus Who Have Completed Protocol AN-SLE3321 (PEARL-SC)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 382 (actual)
• Sponsor: Anthera Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the long-term safety of A-623 in subjects with SLE.

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	A-623	High dose given subcutaneously once a week until A623 is approved for clinical use in SLE or the Sponsor discontinues the study
DRUG	A-623	Low dose given subcutaneously once a week until A623 is approved for clinical use in SLE or the Sponsor discontinues the study
DRUG	A-623	High dose given subcutaneously once every 4 weeks until A623 is approved for clinical use in SLE or the Sponsor discontinues the study

Timeline

• Start date: 2011-04-01
• Primary completion: 2013-07-01
• Completion: 2013-10-01
• First posted: 2011-03-01
• Last updated: 2014-02-13

Locations

71 sites across 11 countries: United States, Argentina, Brazil, Chile, Colombia, Hong Kong, India, Mexico, Peru, Philippines, Taiwan