Safety and Effectiveness of Acthar Gel in Participants With Rheumatoid Arthritis

Mallinckrodt

Status and phase: Completed; Phase 4

Conditions: Arthritis, Rheumatoid

Treatments: Drug: Placebo; Drug: Acthar Gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT02919761

MNK14294063

Details and patient eligibility

About

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.

Enrollment: 259 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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259 participants in 3 patient groups, including a placebo group

Part 1: All Enrolled Participants

Experimental group

Description:

All participants receive Acthar Gel 1 mL twice weekly for 12 weeks

Treatment:

Drug: Acthar Gel

Part 2: Acthar Gel

Experimental group

Description:

Participants receive Acthar Gel 1 mL twice weekly for an additional 12 weeks

Treatment:

Drug: Acthar Gel

Part 2: Placebo

Placebo Comparator group

Description:

Participants receive Placebo 1 mL twice weekly for an additional 12 weeks

Treatment:

Drug: Placebo