Safety and Effectiveness of Acthar Gel in Participants With Rheumatoid Arthritis
NCT ID: NCT02919761
Last Updated: 2020-03-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
259 participants
INTERVENTIONAL
2016-11-07
2019-02-13
Brief Summary
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Part 1 is an Open Label Period in which all eligible participants receive Acthar Gel for 12 weeks. After these 12 weeks of treatment with Acthar Gel, participants will be evaluated for treatment response using the DAS28-ESR.
Participants who have achieved low disease activity (LDA) will enter a double-blind randomized maintenance period (Part 2) and be randomized in a 1:1 ratio to receive either Acthar Gel or matching placebo for an additional 12 weeks.
A single participant might be involved in the trial for as many as 32 weeks.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Part 1: All Enrolled Participants
All participants receive Acthar Gel 1 mL twice weekly for 12 weeks
Acthar Gel
80 Units Acthar Gel per 1 mL for subcutaneous injection
Part 2: Acthar Gel
Participants receive Acthar Gel 1 mL twice weekly for an additional 12 weeks
Acthar Gel
80 Units Acthar Gel per 1 mL for subcutaneous injection
Part 2: Placebo
Participants receive Placebo 1 mL twice weekly for an additional 12 weeks
Placebo
Matching placebo 1 mL for subcutaneous injection
Interventions
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Acthar Gel
80 Units Acthar Gel per 1 mL for subcutaneous injection
Placebo
Matching placebo 1 mL for subcutaneous injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Meets criteria for definite rheumatoid arthritis as defined by 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification at screening
* Has active disease defined as a score of \>3.2 on DAS28-ESR prior to study drug administration despite dual-DMARD treatment
* Is on a stable dose of ≤ 20 mg per week of methotrexate for at least 8 weeks AND a stable dose of an allowed DMARD for at least 24 weeks prior to the screening visit
* May also be on a stable dose of 10 mg or less of prednisone or other the dose equivalent of another corticosteroid for 4 weeks prior to study drug administration
Exclusion Criteria
* Has any history of use of adrenocorticotropic hormone (ACTH) for the treatment of RA
* Has taken B-cell mediated therapies in the 6 months prior to screening
* Has hepatitis B, hepatitis C, history of tuberculosis (TB) or other contraindication as per the United States (US) Prescribing Information for Acthar
* Has history of Type 1 or Type 2 diabetes
* Has any clinically significant infection
18 Years
ALL
No
Sponsors
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Mallinckrodt
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Team Leader
Role: STUDY_DIRECTOR
Mallinckrodt Pharmaceutical
Locations
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East Bay Rheumatology Medical Group
San Leandro, California, United States
Inland Rheumatology Clinical Trials
Upland, California, United States
Orthopedic Research Institute
Boynton Beach, Florida, United States
Clinical Research of West Florida
Clearwater, Florida, United States
Southeastern Integrated Medical, PL, d/b/a Florida Medical Research
Gainesville, Florida, United States
Indago Research and Health Center
Hialeah, Florida, United States
Homestead Associates in Research
Homestead, Florida, United States
Pharmax Research Clinic
Miami, Florida, United States
Suncoast Research Group, LLC
Miami, Florida, United States
San Marcus Research Clinic
Miami Lakes, Florida, United States
Suncoast Clinical Research
New Port Richey, Florida, United States
Omega Research Consultants-DeBary
Orlando, Florida, United States
Millennium Research
Ormond Beach, Florida, United States
Clinical Research of West Florida
Tampa, Florida, United States
Arthritis & Rheumatology of Georgia, PC
Atlanta, Georgia, United States
Arthritis Research and Treatment Center
Stockbridge, Georgia, United States
Arthritis and Diabetes Clinic, Inc.
Monroe, Louisiana, United States
June DO, PC
Lansing, Michigan, United States
Physician Research Collaboration, LLC
Lincoln, Nebraska, United States
DJL Clinical Research
Charlotte, North Carolina, United States
Columbia Arthritis Center
Columbia, South Carolina, United States
West Tennessee Research Institute
Jackson, Tennessee, United States
Ramesh C. Gupta, MD
Memphis, Tennessee, United States
Northwest Med Care
Cypress, Texas, United States
Rheumatic Disease Clinical Research Center
Houston, Texas, United States
Accurate Clinical Research
Houston, Texas, United States
Laila Hassan, MD, PA
Houston, Texas, United States
Pioneer Research Solutions
Houston, Texas, United States
Southwest Rheumatology Research
Mesquite, Texas, United States
Sun Research Institute
San Antonio, Texas, United States
Aprillus Asistencia e Investigación
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
DIM Clínica Privada
Ramos Mejía, Buenos Aires, Argentina
Centro de Investigaciones Reumatológicas
San Miguel de Tucumán, Tucumán Province, Argentina
Centro Polivalente de Asistencia e Investigación Clínica CER San Juan
San Juan, , Argentina
Centro de Investigacion del Noroeste, S.C.
Tijuana, Estado de Baja California, Mexico
Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, Jalisco, Mexico
Clinica de Investigacion en Reumatologia y Obesidad
Guadalajara, Jalisco, Mexico
Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.
Zapopan, Jalisco, Mexico
Hospital De Jesus
Mexico City, Mexico City, Mexico
Consultorio de Reumatología
Mexico City, Mexico City, Mexico
Consultorio Privado del Dr. Miguel Cortes Hernandez
Cuernavaca, Morelos, Mexico
Hospital Universitario Dr. José Eleuterio Gonzalez
Monterrey, Nuevo León, Mexico
Centro de Estudios Clínicos y Especialidades Médicas
Monterrey, Nuevo León, Mexico
Centro de Alta Especialidad en Reumatologia e Investigación del Potosí
San Luis Potosí City, San Luís Potosí, Mexico
Centro Especializado en Investigación Clínica
Boca del Río, Veracruz, Mexico
Centro Peninsular de Investigacion Clinica S.C.P.
Mérida, Yucatán, Mexico
Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
Durango, , Mexico
Phylasis Clinicas Research S de RL de CV
Estado de México, , Mexico
SMIQ
Querétaro, , Mexico
Centro de Atención e Investigación Cardiovascular del Potosí, S.C.
San Luis Potosí City, , Mexico
INBIOMEDYC Toluca
Toluca, , Mexico
Unidad de Enfermedades Reumaticas y Cronico Degenerativas
Torreón, , Mexico
Clinica Santa Monica
Lima, , Peru
Hospital Nacional Cayetano Heredia
Lima, , Peru
ABK Reuma S.R.L. - Medicentro Biociencias
Pueblo Libre, , Peru
Clinica Vesalio
San Borja, , Peru
Hospital de Apoyo Maria Auxiliadora
San Juán de Miraflores, , Peru
Clínica Médica Cayetano Heredia
San Martín de Porres, , Peru
Mindful Medical Research
San Juan, , Puerto Rico
Countries
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References
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Fleischmann R, Furst DE. Safety of repository corticotropin injection as an adjunctive therapy for the treatment of rheumatoid arthritis. Expert Opin Drug Saf. 2020 Aug;19(8):935-944. doi: 10.1080/14740338.2020.1779219. Epub 2020 Jun 16.
Fleischmann R, Furst DE, Connolly-Strong E, Liu J, Zhu J, Brasington R. Repository Corticotropin Injection for Active Rheumatoid Arthritis Despite Aggressive Treatment: A Randomized Controlled Withdrawal Trial. Rheumatol Ther. 2020 Jun;7(2):327-344. doi: 10.1007/s40744-020-00199-3. Epub 2020 Mar 17.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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MNK14294063
Identifier Type: -
Identifier Source: org_study_id
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