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
49
sites
Oklahoma City, Oklahoma 73103
157
mi
from
Oklahoma City, OK
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2147 Northeast Coachman Road
Clearwater, Florida 33765
1102
mi
from
Clearwater, FL
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2128 W Flagler St # 201
Miami, Florida 33144
1319
mi
from
Miami, FL
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Albuquerque, New Mexico 87108
520
mi
from
Albuquerque, NM
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Atlanta, Georgia 30342
798
mi
from
Atlanta, GA
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Atlanta, Georgia 30342
801
mi
from
Atlanta, GA
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1049
mi
from
Boise, ID
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Boynton Beach, Florida 33472
1292
mi
from
Boynton Beach, FL
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Brooklyn, New York 11201
1287
mi
from
Brooklyn, NY
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Charlotte, North Carolina 28210
958
mi
from
Charlotte, NC
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Ciudad Autónoma de Buenos Aires, Buenos Aires
?
mi
from
Ciudad Autónoma de Buenos Aires,
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Cleveland, Ohio 44122
903
mi
from
Cleveland, OH
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Coeur D'Alene, Idaho 83814
1176
mi
from
Coeur D'Alene, ID
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Columbia, South Carolina 29204
974
mi
from
Columbia, SC
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21212 Northwest Freeway
Cypress, Texas 77429
555
mi
from
Cypress, TX
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341
mi
from
Dallas, TX
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Gainesville, Florida 32607
1046
mi
from
Gainesville, FL
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3018 Dixwell Avenue
Hamden, Connecticut 06518
1346
mi
from
Hamden, CT
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1106
mi
from
Hemet, CA
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Hialeah, Florida 33012
1312
mi
from
Hialeah, FL
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Homestead, Florida 33032
1325
mi
from
Homestead, FL
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571
mi
from
Houston, TX
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569
mi
from
Houston, TX
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Houston, Texas 77098
570
mi
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Houston, TX
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Houston, Texas 77089
569
mi
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Houston, TX
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Idaho Falls, Idaho 83404
839
mi
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Idaho Falls, ID
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Jackson, Tennessee 38305
520
mi
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Jackson, TN
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?
mi
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Kansas City, MO
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Knoxville, Tennessee 37923
777
mi
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Knoxville, TN
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Lansing, Michigan 48910
778
mi
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Lansing, MI
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1003 Olde Waterford Way
Leland, North Carolina 28451
1131
mi
from
Leland, NC
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Lincoln, Nebraska 68512
219
mi
from
Lincoln, NE
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Memphis, Tennessee 38119
467
mi
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Memphis, TN
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Mesquite, Texas 75150
346
mi
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Mesquite, TX
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Miami, Florida 33126
1316
mi
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Miami, FL
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Miami Lakes, Florida 33014
1309
mi
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Miami Lakes, FL
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Monroe, Louisiana 71203
485
mi
from
Monroe, LA
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New Port Richey, Florida 34652
1091
mi
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New Port Richey, FL
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7912 Forest City Road
Orlando, Florida 32810
1136
mi
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Orlando, FL
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Ormond Beach, Florida 32174
1126
mi
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Ormond Beach, FL
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6818 West Thunderbird Road
Peoria, Arizona 85381
855
mi
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Peoria, AZ
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1839 Central Avenue
Saint Petersburg, Florida 33713
1116
mi
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Saint Petersburg, FL
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San Antonio, Texas 78215
575
mi
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San Antonio, TX
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San Leandro, California 94578
1324
mi
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San Leandro, CA
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404 Brunn School Road
Santa Fe, New Mexico 87505
472
mi
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Santa Fe, NM
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Stockbridge, Georgia 30281
816
mi
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Stockbridge, GA
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5115 North Armenia Avenue
Tampa, Florida 33603
1114
mi
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Tampa, FL
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Thousand Oaks, California 91360
1199
mi
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Thousand Oaks, CA
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1135
mi
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Upland, CA
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