Open-label Trial of Acthar Gel in Subjects With Moderate to Severe Active Systemic Lupus Erythematosus
Status:
Completed
Trial end date:
2013-04-01
Target enrollment:
Participant gender:
Summary
Systemic lupus erythematosus is a serious and potentially life-threatening condition with
significant unmet medical need. The aim of this Investigator Initiated, single center,
open-label study is to evaluate the efficacy and safety of a daily subcutaneously (SQ)
injection of H.P. Acthar Gel for 10 days with an optional 5 day rescue period for
non-responders after day 10 dose. The primary objective of this study is to evaluate whether
the addition of H.P. Acthar Gel to standard treatment of lupus will ameliorate the intensity
of flares as measured by changes in SLEDAI score, Patient and Physician global assessments.