Acthar Gel for Active Systemic Lupus Erythematosus (SLE)

• Status: Completed
• Trial end date: 2019-10-25
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mallinckrodt
• Treatments: Adrenocorticotropic Hormone

Criteria

Inclusion Criteria:

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

Exclusion criteria:

A patient is not eligible to participate if he/she:

• 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