NCT02919761

Safety and Effectiveness of Acthar Gel in Participants With Rheumatoid Arthritis

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 259 (actual)
• Sponsor: Mallinckrodt · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Arthritis, Rheumatoid

Interventions

Type	Name	Description
DRUG	Acthar Gel	80 Units Acthar Gel per 1 mL for subcutaneous injection
DRUG	Placebo	Matching placebo 1 mL for subcutaneous injection

Timeline

• Start date: 2016-11-07
• Primary completion: 2018-10-17
• Completion: 2019-02-13
• First posted: 2016-09-29
• Last updated: 2020-03-31
• Results posted: 2020-03-23

Locations

59 sites across 5 countries: United States, Argentina, Mexico, Peru, Puerto Rico

Regulatory

• FDA-regulated drug study