A Multicenter, 2 Part Study to Assess the Efficacy and Safety of H.P. Acthar® Gel in Participants With Rheumatoid Arthritis
Status: | Completed |
---|---|
Conditions: | Arthritis, Rheumatoid Arthritis |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/31/2019 |
Start Date: | November 7, 2016 |
End Date: | March 20, 2019 |
A Multicenter, 2 Part Study to Assess the Efficacy and Safety of H.P. Acthar® Gel in Subjects With Rheumatoid Arthritis With Persistently Active Disease
2 part multicenter study to examine the effect of Acthar in adult participants with
rheumatoid arthritis (RA) with persistently active disease. Part 1 is an Open Label Period in
which all eligible participants receive Acthar for 12 weeks. After 12 weeks of treatment with
Acthar, participants will be evaluated for treatment response using the DAS28-ESR.
Participants who have achieved low disease activity will enter a double-blind randomized
maintenance period (Part 2) and be randomized in a 1:1 ratio to receive either Acthar or
matching placebo for an additional 12 weeks.
rheumatoid arthritis (RA) with persistently active disease. Part 1 is an Open Label Period in
which all eligible participants receive Acthar for 12 weeks. After 12 weeks of treatment with
Acthar, participants will be evaluated for treatment response using the DAS28-ESR.
Participants who have achieved low disease activity will enter a double-blind randomized
maintenance period (Part 2) and be randomized in a 1:1 ratio to receive either Acthar or
matching placebo for an additional 12 weeks.
Inclusion Criteria:
1. Participants must meet criteria for rheumatoid arthritis as defined by 2010 American
College of Rheumatology (ACR)/European League Against Rheumatism (EULAR)
classification at screening.
2. Participants must have persistently active rheumatoid arthritis defined as DAS 28-ESR
> 3.2 at screening.
3. Participants must have been on a corticosteroid 12 weeks prior to screening, with a
stable dose of 5-10 mg prednisone (or prednisone equivalent) for 4 weeks prior to
screening.
4. Participants must have been on either a non-biologic or biologic treatment in the 12
weeks prior to screening.
Exclusion Criteria:
1. Participants cannot have used intra-articular steroids within 14 days of the screening
visit.
2. Participants cannot have any known contraindication to Acthar.
3. Participants cannot have Type 1 or Type 2 diabetes.
We found this trial at
49
sites
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Kansas City, Missouri 64114
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