New study of investigational treatment for systemic lupus erythematosus (SLE)
Study Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to
Assess the Efficacy and Safety of H.P. Acthar® Gel in Subjects with Persistently Active Systemic Lupus Erythematosus Despite Moderate-Dose Corticosteroids (SOAR Study)
Sponsor: Mallinckrodt ARD, Inc.
Purpose: The SOAR study is being conducted to see if the study medication is safe and effective in treating patients with SLE. Specifically, the study is looking at whether the study medication, combined with your existing SLE treatment, may better control your SLE symptoms.
What Does this Study Involve?
If you qualify and choose to participate, you will be in the study for up to 32 weeks and will visit the study clinic approximately nine times. You will continue taking your prednisone (or equivalent) plus your other SLE medications. You will also receive the study medication or a placebo. The study medication (and the placebo) will be given by injection (a shot).
To consider participation in this study you must:
- Be 18 years of age or older
- Have symptoms or signs related to your SLE that include rash, and/or joint swelling, and/or pain (arthritis) that have not responded to the treatments you are taking
- Currently be taking prednisone (or equivalent) as part of your SLE treatment
If you have any of the following, you cannot participate in the study:
- Unwilling or unable to take injections (shots)
- Have type 1 or type 2 diabetes
- Have a history of hepatitis or tuberculosis
Phase 4 (U.S.); Phase 2 (outside of U.S.)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
The Lupus Foundation of America works to educate and inform about clinical trial study options available to people with lupus and the importance of getting involved to help advance lupus research. The Lupus Foundation of America does not endorse specific trials.