A Multicenter, 2 Part Study to Assess the Efficacy and Safety of H.P. Acthar® Gel in Subjects With Rheumatoid Arthritis

Description

2 part multicenter study to examine the effect of Acthar in adult subjects with rheumatoid arthritis (RA) with persistently active disease. Part 1 is an Open Label Period in which all eligible subjects receive Acthar for 12 weeks. After 12 weeks of treatment with Acthar, subjects will be evaluated for treatment response using the DAS28-ESR. Subjects 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.

Study Start Date

November, 01 2016

Estimated Completion Date

September 2020

Interventions

  • Drug: Placebo
  • Drug: Acthar

Study ID

Mallinckrodt -- MNK14294063

Status

Unknown

Trial ID

NCT02919761

Study Type

Interventional

Trial Phase

Phase 4

Enrollment Quota

232

Sponsor

Mallinckrodt

Inclusion Criteria

    1. Subjects must meet criteria for rheumatoid arthritis as defined by 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification at screening. 2. Subjects must have persistently active rheumatoid arthritis defined as DAS 28-ESR > 3.2 at screening. 3. Subjects 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. Subjects must have been on either a non-biologic or biologic treatment in the 12 weeks prior to screening.

Exclusion Criteria

    1. Subjects cannot have used intra-articular steroids within 14 days of the screening visit. 2. Subjects cannot have any known contraindication to Acthar. 3. Subjects cannot have Type 1 or Type 2 diabetes.

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (98)

Study Location Distance Name Phone Email
Arthritis Osteoporosis Associates - Hamden, Connecticut 113.8 miles None None None
Arthritis Osteoporosis Associates - Hamden, Connecticut 113.8 miles None None None
Arthritis Osteoporosis Associates - Hamden, Connecticut 113.8 miles None None None
Arthritis Osteoporosis Associates - Hamden, Connecticut 113.8 miles None None None
Arthritis Osteoporosis Associates - Hamden, Connecticut 113.8 miles None None None
Emkey Arthritis Osteoporosis Clinic - Wyomissing, Pennsylvania 289.8 miles None None None
Emkey Arthritis Osteoporosis Clinic - Wyomissing, Pennsylvania 289.8 miles None None None
Emkey Arthritis Osteoporosis Clinic - Wyomissing, Pennsylvania 289.8 miles None None None
Emkey Arthritis Osteoporosis Clinic - Wyomissing, Pennsylvania 289.8 miles None None None
Emkey Arthritis Osteoporosis Clinic - Wyomissing, Pennsylvania 289.8 miles None None None
Rapid Medical Research - Cleveland, Ohio 539.9 miles None None None
June DO PC - Lansing, Michigan 685.8 miles None None None
June DO PC - Lansing, Michigan 685.8 miles None None None
June DO PC - Lansing, Michigan 685.8 miles None None None
June DO PC - Lansing, Michigan 685.8 miles None None None
June DO PC - Lansing, Michigan 685.8 miles None None None
DJL Clinical Research - Charlotte, North Carolina 726.2 miles None None None
Columbia Arthritis Center - Columbia, South Carolina 788.8 miles None None None
New Phase Research and Development - Knoxville, Tennessee 822.5 miles None None None
Arthritis Rheumatology of Georgia PC - Atlanta, Georgia 929.9 miles None None None
Arthritis Rheumatology of Georgia PC - Atlanta, Georgia 929.9 miles None None None
Arthritis Rheumatology of Georgia PC - Atlanta, Georgia 929.9 miles None None None
Arthritis Rheumatology of Georgia PC - Atlanta, Georgia 929.9 miles None None None
Arthritis Rheumatology of Georgia PC - Atlanta, Georgia 929.9 miles None None None
iResearch Atlanta - Decatur, Georgia 931.8 miles None None None
Arthritis Research and Treatment Center - Stockbridge, Georgia 938.9 miles None None None
West Tennessee Research Institute - Jackson, Tennessee 1,057.2 miles None None None
Millennium Research - Ormond Beach, Florida 1,064.8 miles None None None
Florida Medical Research Institute - Gainesville, Florida 1,083.3 miles None None None
Omega Research ConsultantsDeBary - Orlando, Florida 1,114.6 miles None None None
Omega Research ConsultantsDeBary - Orlando, Florida 1,114.6 miles None None None
Omega Research ConsultantsDeBary - Orlando, Florida 1,114.6 miles None None None
Omega Research ConsultantsDeBary - Orlando, Florida 1,114.6 miles None None None
Omega Research ConsultantsDeBary - Orlando, Florida 1,114.6 miles None None None
Office of Ramesh C Gupta MD - Memphis, Tennessee 1,128.4 miles None None None
Office of Ramesh C Gupta MD - Memphis, Tennessee 1,128.4 miles None None None
Office of Ramesh C Gupta MD - Memphis, Tennessee 1,128.4 miles None None None
Office of Ramesh C Gupta MD - Memphis, Tennessee 1,128.4 miles None None None
Office of Ramesh C Gupta MD - Memphis, Tennessee 1,128.4 miles None None None
Suncoast Clinical Research - New Port Richey, Florida 1,176.4 miles None None None
Clinical Research of West Florida - Clearwater, Florida 1,192.6 miles None None None
Orthopedic Research Institute - Boynton Beach, Florida 1,197.4 miles None None None
San Marcus Research Clinic - Miami, Florida 1,252.5 miles None None None
Advanced Pharma CR - Miami, Florida 1,256.4 miles None None None
Indago Research and Health Center - Hialeah, Florida 1,256.9 miles None None None
Little Rock Diagnostic Clinic - Little Rock, Arkansas 1,261.1 miles None None None
Pharmax Research Clinic - Miami, Florida 1,262.4 miles None None None
Homestead Associates in Research - Homestead, Florida 1,281.2 miles None None None
Physician Research Collaboration LLC - Lincoln, Nebraska 1,323.8 miles None None None
Physician Research Collaboration LLC - Lincoln, Nebraska 1,323.8 miles None None None
Physician Research Collaboration LLC - Lincoln, Nebraska 1,323.8 miles None None None
Physician Research Collaboration LLC - Lincoln, Nebraska 1,323.8 miles None None None
Physician Research Collaboration LLC - Lincoln, Nebraska 1,323.8 miles None None None
Arthritis and Diabetes Clinic Inc - Monroe, Louisiana 1,331.9 miles None None None
Arthritis and Diabetes Clinic Inc - Monroe, Louisiana 1,331.9 miles None None None
Arthritis and Diabetes Clinic Inc - Monroe, Louisiana 1,331.9 miles None None None
Arthritis and Diabetes Clinic Inc - Monroe, Louisiana 1,331.9 miles None None None
Arthritis and Diabetes Clinic Inc - Monroe, Louisiana 1,331.9 miles None None None
Arthritis Rheumatology Center of Oklahoma - Oklahoma City, Oklahoma 1,496.0 miles None None None
Arthritis Rheumatology Center of Oklahoma - Oklahoma City, Oklahoma 1,496.0 miles None None None
Arthritis Rheumatology Center of Oklahoma - Oklahoma City, Oklahoma 1,496.0 miles None None None
Arthritis Rheumatology Center of Oklahoma - Oklahoma City, Oklahoma 1,496.0 miles None None None
Arthritis Rheumatology Center of Oklahoma - Oklahoma City, Oklahoma 1,496.0 miles None None None
Southwest Rheumatology Research - Mesquite, Texas 1,541.2 miles None None None
Accurate Clinical Research - Houston, Texas 1,604.8 miles None None None
Rheumatic Disease Clinical Research Center - Houston, Texas 1,607.3 miles None None None
Northwest Med Care - Cypress, Texas 1,609.8 miles None None None
Arthritis and Osteoporosis Clinic of Brazos Valley - College Station, Texas 1,614.0 miles None None None
Pioneer Research Solutions - Houston, Texas 1,620.2 miles None None None
Sun Research Institute - San Antonio, Texas 1,766.6 miles None None None
Santa Fe Rheumatology - Santa Fe, New Mexico 1,919.9 miles None None None
Lovelace Scientific Resources Inc - Albuquerque, New Mexico 1,967.3 miles None None None
Lovelace Scientific Resources Inc - Albuquerque, New Mexico 1,967.3 miles None None None
Lovelace Scientific Resources Inc - Albuquerque, New Mexico 1,967.3 miles None None None
Lovelace Scientific Resources Inc - Albuquerque, New Mexico 1,967.3 miles None None None
Lovelace Scientific Resources Inc - Albuquerque, New Mexico 1,967.3 miles None None None
Institute of Arthritis Research - Idaho Falls, Idaho 2,055.7 miles None None None
Coeur DAlene Arthritis Clinic - Coeur d'Alene, Idaho 2,233.3 miles None None None
Coeur DAlene Arthritis Clinic - Coeur d'Alene, Idaho 2,233.3 miles None None None
Coeur DAlene Arthritis Clinic - Coeur d'Alene, Idaho 2,233.3 miles None None None
Coeur DAlene Arthritis Clinic - Coeur d'Alene, Idaho 2,233.3 miles None None None
Coeur DAlene Arthritis Clinic - Coeur d'Alene, Idaho 2,233.3 miles None None None
Advanced Clinical Research Idaho - Boise, Idaho 2,268.1 miles None None None
Advanced Clinical Research Idaho - Boise, Idaho 2,268.1 miles None None None
Advanced Clinical Research Idaho - Boise, Idaho 2,268.1 miles None None None
Advanced Clinical Research Idaho - Boise, Idaho 2,268.1 miles None None None
Advanced Clinical Research Idaho - Boise, Idaho 2,268.1 miles None None None
SunValley Arthritis Center - Peoria, Arizona 2,302.0 miles None None None
Arizona Arthritis and Rheumatology Research - Sun City, Arizona 2,304.3 miles None None None
CV Mehta MD Medical Corporation - Hemet, California 2,541.8 miles None None None
CV Mehta MD Medical Corporation - Hemet, California 2,541.8 miles None None None
CV Mehta MD Medical Corporation - Hemet, California 2,541.8 miles None None None
CV Mehta MD Medical Corporation - Hemet, California 2,541.8 miles None None None
CV Mehta MD Medical Corporation - Hemet, California 2,541.8 miles None None None
Inland Rheumatology Clinical Trials - Upland, California 2,563.9 miles None None None
Valerius Medical Group and Research Center - Los Alamitos, California 2,594.1 miles None None None
Westlake Medical Research - Thousand Oaks, California 2,622.6 miles None None None
East Bay Rheumatology Medical Group - San Leandro, California 2,684.7 miles None None None

ClinicalTrialsLocator.com provides clinical trial listings in an easy to view format. All clinical trial information is pulled directly from ClinicalTrials.gov. This website does not guarantee acceptance into any clinical trial, and is not responsible for adverse events that may be incurred from a clinical trial.