Who is sponsoring NCT02919761?

NCT02919761 is sponsored by Mallinckrodt.

What condition does NCT02919761 study?

NCT02919761 studies Arthritis, Rheumatoid.

What drugs are being tested in NCT02919761?

Interventions: Acthar Gel, Placebo.

What is the status of NCT02919761?

NCT02919761 is currently COMPLETED.

Last reviewed 2020-03-31 · How we verify

Safety and Effectiveness of Acthar Gel in Participants With Rheumatoid Arthritis

NCT02919761 PHASE4 COMPLETED Results posted

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.

Details

Lead sponsor	Mallinckrodt
Phase	PHASE4
Status	COMPLETED
Enrolment	259
Start date	Mon Nov 07 2016 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Wed Feb 13 2019 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

Arthritis, Rheumatoid

Interventions

Acthar Gel
Placebo

Countries

Peru, Mexico, Argentina, Puerto Rico, United States