Arthritis, Rheumatoid Clinical Trial
Official title:
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
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.
n/a
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