Overview

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

Status:
Completed
Trial end date:
2013-10-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the long-term safety of A-623 in subjects with SLE.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Anthera Pharmaceuticals
Criteria
Inclusion Criteria:

- Completed the treatment period specified in study AN-SLE3321 or were enrolled in study
AN-SLE3321 prior to November 30, 2010

Exclusion Criteria:

- Developed a new medical disease or condition that has made the subject unsuitable for
this study in the opinion of the Investigator, including interference with written
informed consent, study evaluation, completion, and/or procedures

- Pregnant or nursing

- Any prior administration of a B-cell modulating therapy other than A-623

- Received cyclophosphamide, cyclosporine, anti-TNF alpha therapies, transfusion,
plasmapheresis or plasma exchange, IV immunoglobulin, or live vaccines according to
listed wash-out periods