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Safety and Effectiveness of Acthar Gel in Participants With Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT02919761
Recruitment Status : Completed
First Posted : September 29, 2016
Last Update Posted : November 7, 2019
Sponsor:
Information provided by (Responsible Party):
Mallinckrodt

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Arthritis, Rheumatoid Drug: Acthar Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 259 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : November 7, 2016
Actual Primary Completion Date : February 2019
Actual Study Completion Date : March 20, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Open Label
Acthar 1 mL (80 U) 2x/week
Drug: Acthar
Experimental: Acthar
Acthar 1 mL (80 U) 2x/week
Drug: Acthar
Placebo Comparator: Placebo
Placebo 1 mL
Drug: Placebo



Primary Outcome Measures :
  1. Proportion of participants with Disease Activity Score with 28 joint count and Erythrocyte Sedimentation Rate (DAS28-ESR) [ Time Frame: 12 Weeks ]
    Proportion of participants with DAS28-ESR <3.2 at Week 12


Secondary Outcome Measures :
  1. Proportion of participants who maintained DAS28-ESR [ Time Frame: 24 Weeks ]
    Proportion of participants with Low Disease Activity as defined by DAS28-ESR <3.2 at Week 24



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02919761


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Locations
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United States, Arizona
SunValley Arthritis Center
Peoria, Arizona, United States, 85381
United States, California
C.V. Mehta MD Medical Corporation
Hemet, California, United States, 92543
East Bay Rheumatology Medical Group
San Leandro, California, United States, 94578
Westlake Medical Research
Thousand Oaks, California, United States, 91360
Inland Rheumatology Clinical Trials
Upland, California, United States, 91786
United States, Connecticut
Arthritis & Osteoporosis Associates
Hamden, Connecticut, United States, 06518
United States, Florida
Orthopedic Research Institute
Boynton Beach, Florida, United States, 33472
Clinical Research of West Florida
Clearwater, Florida, United States, 33765
Florida Medical Research Institute
Gainesville, Florida, United States, 32607
Indago Research and Health Center
Hialeah, Florida, United States, 33012
Homestead Associates in Research
Homestead, Florida, United States, 33032
San Marcus Research Clinic
Miami Lakes, Florida, United States, 33015
Pharmax Research Clinic
Miami, Florida, United States, 33126
Suncoast Research Group, LLC
Miami, Florida, United States, 33135
Suncoast Clinical Research
New Port Richey, Florida, United States, 34652
Omega Research Consultants-DeBary
Orlando, Florida, United States, 32810
Millennium Research
Ormond Beach, Florida, United States, 32174
Professional Health Care of Pinellas
Saint Petersburg, Florida, United States, 33713
Clinical Research of West Florida
Tampa, Florida, United States, 33603
United States, Georgia
Primary Care Research
Atlanta, Georgia, United States, 30312
Arthritis & Rheumatology of Georgia, PC
Atlanta, Georgia, United States, 30342
Arthritis Research and Treatment Center
Stockbridge, Georgia, United States, 30281
United States, Idaho
Advanced Clinical Research - Idaho
Boise, Idaho, United States, 83642
Coeur D'Alene Arthritis Clinic
Coeur d'Alene, Idaho, United States, 83814
Institute of Arthritis Research
Idaho Falls, Idaho, United States, 83404
United States, Louisiana
Arthritis and Diabetes Clinic, Inc.
Monroe, Louisiana, United States, 71203
United States, Michigan
June DO, PC
Lansing, Michigan, United States, 48910
United States, Missouri
Kansas City Internal Medicine (KCIM) - St. Joseph/Carondelet Campus Location
Kansas City, Missouri, United States, 64114
United States, Nebraska
Physician Research Collaboration, LLC
Lincoln, Nebraska, United States, 68516
United States, New Mexico
Lovelace Scientific Resources, Inc.
Albuquerque, New Mexico, United States, 87108
Santa Fe Rheumatology
Santa Fe, New Mexico, United States, 87505
United States, New York
Weill Cornell Physicians at Brooklyn
Brooklyn, New York, United States, 11201
United States, North Carolina
DJL Clinical Research
Charlotte, North Carolina, United States, 28210
Cape Fear Arthritis Care
Leland, North Carolina, United States, 28451
United States, Ohio
Rapid Medical Research
Cleveland, Ohio, United States, 44122
United States, Oklahoma
Arthritis & Rheumatology Center of Oklahoma
Oklahoma City, Oklahoma, United States, 73101
United States, South Carolina
Columbia Arthritis Center
Columbia, South Carolina, United States, 29204
United States, Tennessee
West Tennessee Research Institute
Jackson, Tennessee, United States, 38305
New Phase Research and Development
Knoxville, Tennessee, United States, 37909
Office of Ramesh C. Gupta, MD
Memphis, Tennessee, United States, 38119
United States, Texas
Northwest Med Care
Cypress, Texas, United States, 77429
Metroplex Clinical Research Center
Dallas, Texas, United States, 75231
Rheumatic Disease Clinical Research Center
Houston, Texas, United States, 77004
Accurate Clinical Research
Houston, Texas, United States, 77034
Laila Hassan, MD, PA
Houston, Texas, United States, 77089
Pioneer Research Solutions
Houston, Texas, United States, 77099
Southwest Rheumatology Research
Mesquite, Texas, United States, 75150
Sun Research Institute
San Antonio, Texas, United States, 78215
Argentina
Aprillus Asistencia e Investigación
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1046AAQ
DIM Clínica Privada
Ramos Mejía, Buenos Aires, Argentina, 1704
Centro de Investigaciones Reumatológicas
San Miguel De Tucumán, Tucuman, Argentina, T4000BRD
Centro Polivalente de Asistencia e Investigación Clínica CER San Juan
San Juan, Argentina, J5402DIL
Centro Medico Privado de Reumatología
Tucumán, Argentina, T4000AXL
Mexico
Centro de Investigacion del Noroeste, S.C.
Tijuana, Baja California, Mexico, 22010
Hospital De Jesus
Mexico, Distrito Federal, Mexico, 06090
Consultorio de Reumatología
Mexico, Distrito Federal, Mexico, 07760
Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, Jalisco, Mexico, 44280
Clinica de Investigacion en Reumatologia y Obesidad
Guadalajara, Jalisco, Mexico, 44650
Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.
Zapopan, Jalisco, Mexico, 45030
Consultorio Privado del Dr. Miguel Cortes Hernandez
Cuernavaca, Morelos, Mexico, 62290
Centro de Estudios Clínicos y Especialidades Médicas
Monterrey, Nuevo LEON, Mexico, 64620
Hospital Universitario Dr. José Eleuterio Gonzalez
Monterrey, Nuevo León, Mexico, 64460
Centro de Alta Especialidad en Reumatologia e Investigación del Potosí
San Luis Potosí, San Luís Potosí, Mexico, 78213
Centro Especializado en Investigación Clínica
Boca Del Río, Veracruz, Mexico, 94290
Centro Peninsular de Investigacion Clinica S.C.P.
Mérida, Yucatan, Mexico, 97000
Investigacion y Biomedicina de Chihuahua, S.C.
Chihuahua, Mexico, 31000
Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
Durango, Mexico, 34000
Phylasis Clinicas Research S de RL de CV
Estado de México, Mexico, 54769
SMIQ
Querétaro, Mexico, 76090
Centro de Atención e Investigación Cardiovascular del Potosí, S.C.
San Luis Potosí, Mexico, 78200
Investigacion Biomedica y Clinica Toluca
Toluca, Mexico, 50130
Unidad de Enfermedades Reumaticas y Cronico Degenerativas
Torreon, Mexico, 27000
Peru
Clinica Santa Monica
Lima, Peru, 15046
Hospital Nacional Cayetano Heredia
Lima, Peru, 15102
ABK Reuma S.R.L. - Medicentro Biociencias
Pueblo Libre, Peru, 15084
Clinica Vesalio
San Borja, Peru, 15036
Hospital de Apoyo Maria Auxiliadora
San Juán De Miraflores, Peru, 15801
Clínica Médica Cayetano Heredia
San Martín De Porres, Peru, 15102
Puerto Rico
Mindful Medical Research
San Juan, Puerto Rico, 00918
Sponsors and Collaborators
Mallinckrodt
Investigators
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Study Director: Clinical Team Leader Mallinckrodt Pharmaceutical

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Responsible Party: Mallinckrodt
ClinicalTrials.gov Identifier: NCT02919761     History of Changes
Other Study ID Numbers: MNK14294063
First Posted: September 29, 2016    Key Record Dates
Last Update Posted: November 7, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Mallinckrodt:
persistant disease activity
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Adrenocorticotropic Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs