Safety and Effectiveness of Acthar Gel in Participants With Rheumatoid Arthritis

Completed · Phase 4 · Has a placebo group

Conditions studied: Arthritis, Rheumatoid

In brief

This is a 2-part study to examine the effect of Acthar Gel in adult participants with rheumatoid arthritis (RA) with persistently active disease even after receiving two other treatments intended to modify the disease. Part 1 is an Open Label Period in which all eligible participants receive Acthar Gel for 12 weeks. After these 12 weeks of treatment with Acthar Gel, participants will be evaluated for treatment response using the DAS28-ESR. Participants who have achieved low disease activity (LDA) will enter a double-blind randomized maintenance period (Part 2) and be randomized in a 1:1 ratio to receive either Acthar Gel or matching placebo for an additional 12 weeks. A single participant might be involved in the trial for as many as 32 weeks.

Key facts

Study ID

NCT02919761

Run by

Mallinckrodt

People needed

259

Starts

2016-11-07

Expected to finish

2019-02-13

Last updated by the study team

2020-03-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or nonpregnant, nonlactating female subjects
• Meets criteria for definite rheumatoid arthritis as defined by 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification at screening
• Has active disease defined as a score of >3.2 on DAS28-ESR prior to study drug administration despite dual-DMARD treatment
• Is on a stable dose of ≤ 20 mg per week of methotrexate for at least 8 weeks AND a stable dose of an allowed DMARD for at least 24 weeks prior to the screening visit
• May also be on a stable dose of 10 mg or less of prednisone or other the dose equivalent of another corticosteroid for 4 weeks prior to study drug administration

You may not qualify if…

• Has current rheumatoid disease or inflammatory joint disease other than RA
• Has any history of use of adrenocorticotropic hormone (ACTH) for the treatment of RA
• Has taken B-cell mediated therapies in the 6 months prior to screening
• Has hepatitis B, hepatitis C, history of tuberculosis (TB) or other contraindication as per the United States (US) Prescribing Information for Acthar
• Has history of Type 1 or Type 2 diabetes
• Has any clinically significant infection

Where it is running

• Inland Rheumatology Clinical Trials — Upland, California, United States
• Orthopedic Research Institute — Boynton Beach, Florida, United States
• Clinical Research of West Florida — Clearwater, Florida, United States
• Southeastern Integrated Medical, PL, d/b/a Florida Medical Research — Gainesville, Florida, United States
• Indago Research and Health Center — Hialeah, Florida, United States
• Homestead Associates in Research — Homestead, Florida, United States
• Pharmax Research Clinic — Miami, Florida, United States
• Suncoast Research Group, LLC — Miami, Florida, United States
• San Marcus Research Clinic — Miami Lakes, Florida, United States
• Suncoast Clinical Research — New Port Richey, Florida, United States
• Omega Research Consultants-DeBary — Orlando, Florida, United States
• Millennium Research — Ormond Beach, Florida, United States
• Clinical Research of West Florida — Tampa, Florida, United States
• Arthritis & Rheumatology of Georgia, PC — Atlanta, Georgia, United States
• Arthritis Research and Treatment Center — Stockbridge, Georgia, United States
• Arthritis and Diabetes Clinic, Inc. — Monroe, Louisiana, United States
• June DO, PC — Lansing, Michigan, United States
• Physician Research Collaboration, LLC — Lincoln, Nebraska, United States
• DJL Clinical Research — Charlotte, North Carolina, United States
• Columbia Arthritis Center — Columbia, South Carolina, United States
• West Tennessee Research Institute — Jackson, Tennessee, United States
• Ramesh C. Gupta, MD — Memphis, Tennessee, United States
• Northwest Med Care — Cypress, Texas, United States
• Rheumatic Disease Clinical Research Center — Houston, Texas, United States
• East Bay Rheumatology Medical Group — San Leandro, California, United States

Full record on ClinicalTrials.gov

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