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.
80 Units Acthar Gel per 1 mL for subcutaneous injection
Matching placebo 1 mL for subcutaneous injection
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Ramos Mejía, Buenos Aires, Argentina
San Miguel de Tucumán, Tucumán Province, Argentina
San Juan, Argentina