At a glance
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A Multicenter, 2 Part Study to Assess the Efficacy and Safety of Acthar Gel in Subjects With Rheumatoid Arthritis With Persistently Active Disease Despite Dual-DMARD Treatment
In Brief
A Phase 4 clinical trial evaluating Acthar Gel and Placebo for Arthritis, Rheumatoid. Completed, enrolled 259 participants across 59 sites in 5 countries.
Detailed Summary
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.
Study Details
Timeline
Interventions
80 Units Acthar Gel per 1 mL for subcutaneous injection
Matching placebo 1 mL for subcutaneous injection