Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Mallinckrodt
This trial was initiated (started recruiting) in October 2016, but first patient was not enrolled (randomized) until December, 2016.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
To be eligible to participate in this trial, a patient must:
Have a diagnosis of SLE according to 4 of the American College of Rheumatology revised criteria
Have active SLE
Have moderate to severe rash and/or arthritis as demonstrated by BILAG-2004 score A or B in the mucocutaneous and/or musculoskeletal body systems at both Screening and Randomization Visits
Have a documented history or screening result of
1. positive antinuclear antibody (ANA), OR
2. elevated anti-dsDNA or extractable nuclear antigen (ENA) antibodies
Have been on prednisone (or prednisone equivalent) before the screening visit:
1. at least 8 weeks, and
2. at a stable dose of 7.5 mg to 30 mg for at least 4 weeks
You may not be if
Has a history of sensitivity to adrenocorticotropic hormone (ACTH) preparations or porcine products
Has active lupus nephritis
Has active central nervous system (CNS) manifestations of SLE