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

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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.


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
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Memphis, Tennessee 38119
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2147 Northeast Coachman Road
Clearwater, Florida 33765
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2128 W Flagler St # 201
Miami, Florida 33144
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Albuquerque, New Mexico 87108
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Atlanta, Georgia 30342
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Atlanta, Georgia 30342
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Boise, ID
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Boynton Beach, Florida 33472
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Brooklyn, New York 11201
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Charlotte, North Carolina 28210
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Ciudad Autónoma de Buenos Aires, Buenos Aires
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Cleveland, Ohio 44122
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Coeur D'Alene, Idaho 83814
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Columbia, South Carolina 29204
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21212 Northwest Freeway
Cypress, Texas 77429
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Dallas, TX
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Gainesville, Florida 32607
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3018 Dixwell Avenue
Hamden, Connecticut 06518
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Hemet, CA
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Hialeah, Florida 33012
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Homestead, Florida 33032
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Houston, TX
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Houston, Texas 77098
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Houston, Texas 77089
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Idaho Falls, Idaho 83404
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Jackson, Tennessee 38305
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Knoxville, Tennessee 37923
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Lansing, Michigan 48910
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1003 Olde Waterford Way
Leland, North Carolina 28451
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Lincoln, Nebraska 68512
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Mesquite, Texas 75150
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Miami, Florida 33126
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Miami Lakes, Florida 33014
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Monroe, Louisiana 71203
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New Port Richey, Florida 34652
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Oklahoma City, Oklahoma 73103
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7912 Forest City Road
Orlando, Florida 32810
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Ormond Beach, Florida 32174
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6818 West Thunderbird Road
Peoria, Arizona 85381
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1839 Central Avenue
Saint Petersburg, Florida 33713
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San Antonio, Texas 78215
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San Leandro, California 94578
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404 Brunn School Road
Santa Fe, New Mexico 87505
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Stockbridge, Georgia 30281
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5115 North Armenia Avenue
Tampa, Florida 33603
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Thousand Oaks, California 91360
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