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Acthar Gel for Active Systemic Lupus Erythematosus (SLE) | Clinical Trials | Clareo Health

COMPLETEDPHASE4

Acthar Gel for Active Systemic Lupus Erythematosus (SLE)

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

NCT02953821•Mallinckrodt

View on ClinicalTrials.gov

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

Detailed Description

This trial was initiated (started recruiting) in October 2016, but first patient was not enrolled (randomized) until December, 2016.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

•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

Locations (39)

C.V. Mehta MD Medical Corporation

Hemet, California, United States

Inland Rheumatology Clinical Trials

Upland, California, United States

Center for Rheumatology Immunology and Arthritis

Fort Lauderdale, Florida, United States

San Marcus Research Clinic

Miami, Florida, United States

Advanced Pharma CR

Miami, Florida, United States

Millennium Research

Ormond Beach, Florida, United States

Office of George Timothy Kelly MD

Las Vegas, Nevada, United States

NewYork-Presbyterian Columbia University Medical Center

New York, New York, United States

DJL Clinical Research

Charlotte, North Carolina, United States

Paramount Medical Research & Consulting

Middleburg Heights, Ohio, United States

Key Dates

Start Date

December 16, 2016

Primary Completion Date

July 31, 2019

Completion Date

October 25, 2019

Last Updated

August 20, 2020

Enrollment

172

ACTUAL participants

Conditions

Lupus Erythematosus, Systemic

Interventions

Acthar Gel

DRUG

Placebo Gel

DRUG

A Study of CC-97540 (BMS-986353 or Zola-cel), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite Immunosuppressants (Breakfree-SLE)

NCT07015983

Lupus Erythematosus, SystemicLupus Nephritis

View study

RECRUITINGPHASE3

A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus

NCT07438496

Lupus Erythematosus, Systemic

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 20, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Acthar Gel for Active Systemic Lupus Erythematosus (SLE)

Inclusion Criteria

Exclusion Criteria

A Study of CC-97540 (BMS-986353 or Zola-cel), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite Immunosuppressants (Breakfree-SLE)

A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus

Anifrolumab Real-world Treatment Outcomes in Systemic Lupus Erythematosus

A Research Study to Evaluate the Effects of a New Oral Medicine Called Cenerimod in Adults With Systemic Lupus Erythematosus

Vunakizumab for the Treatment of Mild to Moderate Systemic Lupus Erythematosus

Exploratory Clinical Study of CNCT19 Anti CD19 Cell Therapy in the Treatment of Refractory Autoimmune Diseases