At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of SLE according to 4 of the American College of Rheumatology revised criteria
- ✓Have active SLE
- ✓Moderate to severe rash and/or arthritis with BILAG-2004 score A or B in mucocutaneous and/or musculoskeletal systems at both Screening and Randomization
- ✓Positive ANA or elevated anti-dsDNA or ENA antibodies
- ✕History of sensitivity to ACTH preparations or porcine products
- ✕Active lupus nephritis
- ✕Active CNS manifestations of SLE
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Randomized, Double Blind, Placebo Controlled Study to Assess the Efficacy and Safety of Acthar Gel in Subjects With Persistently Active Systemic Lupus Erythematosus Despite Moderate Dose Corticosteroids
In Brief
A Phase 4 clinical trial evaluating Acthar Gel and Placebo Gel for Lupus Erythematosus, Systemic. Completed, enrolled 172 participants across 39 sites in 5 countries.
Detailed Summary
This trial is to study Acthar Gel in participants with active systemic lupus erythematosus (SLE). The doctor will assign eligible patients to one of two groups (like flipping a coin). Participants will receive the treatment assigned to their group for 24 weeks: * Acthar Gel * Placebo Gel, which looks like Acthar Gel, but has no medicine in it. The doctor or his staff will take measurements and ask questions to: * see how well the gel is working * see how safe it is for patients with SLE
Study Details
Timeline
Interventions
1 mL (80 Units) given by a shot under the skin (via subcutaneous injection)
1 mL (0 Units) given by a shot under the skin (via subcutaneous injection)