Safety and Effectiveness of Acthar Gel in Participants With Rheumatoid Arthritis
A Multicenter, 2 Part Study to Assess the Efficacy and Safety of Acthar Gel in Subjects With Rheumatoid Arthritis With Persistently Active Disease Despite Dual-DMARD Treatment
1 other identifier
interventional
259
5 countries
59
Brief Summary
This is a 2-part study to examine the effect of Acthar Gel in adult participants with rheumatoid arthritis (RA) with persistently active disease even after receiving two other treatments intended to modify the disease. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 2016
Typical duration for phase_4
59 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 26, 2016
CompletedFirst Posted
Study publicly available on registry
September 29, 2016
CompletedStudy Start
First participant enrolled
November 7, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 17, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 13, 2019
CompletedResults Posted
Study results publicly available
March 23, 2020
CompletedMarch 31, 2020
March 1, 2020
1.9 years
September 26, 2016
March 6, 2020
March 20, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Part 1: Number of Participants With Low Disease Activity (LDA) by Visit
LDA is defined as DAS28 \<3.2.
Baseline to Week 12
Part 2: Number of Participants Who Maintained Low Disease Activity by Visit
Low disease activity is defined as DAS28 \<3.2.
Week 12 to Week 24
Secondary Outcomes (12)
Part 1: Swollen Joint Count by Visit
Baseline to Week 12
Part 2: Swollen Joint Count by Visit During Part 2
Baseline, Week 12 to Week 24
Part 1: Tender Joint Count by Visit
Baseline to Week 12
Part 2: Tender Joint Count by Visit
Baseline, Week 12 to Week 24
Part 1: Patient-Reported General Health by Visit
Baseline to Week 12
- +7 more secondary outcomes
Study Arms (3)
Part 1: All Enrolled Participants
EXPERIMENTALAll participants receive Acthar Gel 1 mL twice weekly for 12 weeks
Part 2: Acthar Gel
EXPERIMENTALParticipants receive Acthar Gel 1 mL twice weekly for an additional 12 weeks
Part 2: Placebo
PLACEBO COMPARATORParticipants receive Placebo 1 mL twice weekly for an additional 12 weeks
Interventions
80 Units Acthar Gel per 1 mL for subcutaneous injection
Matching placebo 1 mL for subcutaneous injection
Eligibility Criteria
You may qualify if:
- Male or nonpregnant, nonlactating female subjects
- 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
You may not qualify if:
- Has current rheumatoid disease or inflammatory joint disease other than RA
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mallinckrodtlead
Study Sites (59)
East Bay Rheumatology Medical Group
San Leandro, California, 94578, United States
Inland Rheumatology Clinical Trials
Upland, California, 91786, United States
Orthopedic Research Institute
Boynton Beach, Florida, 33472, United States
Clinical Research of West Florida
Clearwater, Florida, 33765, United States
Southeastern Integrated Medical, PL, d/b/a Florida Medical Research
Gainesville, Florida, 32607, United States
Indago Research and Health Center
Hialeah, Florida, 33012, United States
Homestead Associates in Research
Homestead, Florida, 33032, United States
Pharmax Research Clinic
Miami, Florida, 33126, United States
Suncoast Research Group, LLC
Miami, Florida, 33135, United States
San Marcus Research Clinic
Miami Lakes, Florida, 33015, United States
Suncoast Clinical Research
New Port Richey, Florida, 34652, United States
Omega Research Consultants-DeBary
Orlando, Florida, 32810, United States
Millennium Research
Ormond Beach, Florida, 32174, United States
Clinical Research of West Florida
Tampa, Florida, 33603, United States
Arthritis & Rheumatology of Georgia, PC
Atlanta, Georgia, 30342, United States
Arthritis Research and Treatment Center
Stockbridge, Georgia, 30281, United States
Arthritis and Diabetes Clinic, Inc.
Monroe, Louisiana, 71203, United States
June DO, PC
Lansing, Michigan, 48910, United States
Physician Research Collaboration, LLC
Lincoln, Nebraska, 68516, United States
DJL Clinical Research
Charlotte, North Carolina, 28210, United States
Columbia Arthritis Center
Columbia, South Carolina, 29204, United States
West Tennessee Research Institute
Jackson, Tennessee, 38305, United States
Ramesh C. Gupta, MD
Memphis, Tennessee, 38119, United States
Northwest Med Care
Cypress, Texas, 77429, United States
Rheumatic Disease Clinical Research Center
Houston, Texas, 77004, United States
Accurate Clinical Research
Houston, Texas, 77034, United States
Laila Hassan, MD, PA
Houston, Texas, 77089, United States
Pioneer Research Solutions
Houston, Texas, 77099, United States
Southwest Rheumatology Research
Mesquite, Texas, 75150, United States
Sun Research Institute
San Antonio, Texas, 78215, United States
Aprillus Asistencia e Investigación
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1046AAQ, Argentina
DIM Clínica Privada
Ramos Mejía, Buenos Aires, 1704, Argentina
Centro de Investigaciones Reumatológicas
San Miguel de Tucumán, Tucumán Province, T4000BRD, Argentina
Centro Polivalente de Asistencia e Investigación Clínica CER San Juan
San Juan, J5402DIL, Argentina
Centro de Investigacion del Noroeste, S.C.
Tijuana, Estado de Baja California, 22010, Mexico
Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, Jalisco, 44280, Mexico
Clinica de Investigacion en Reumatologia y Obesidad
Guadalajara, Jalisco, 44650, Mexico
Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.
Zapopan, Jalisco, 45030, Mexico
Hospital De Jesus
Mexico City, Mexico City, 06090, Mexico
Consultorio de Reumatología
Mexico City, Mexico City, 07760, Mexico
Consultorio Privado del Dr. Miguel Cortes Hernandez
Cuernavaca, Morelos, 62290, Mexico
Hospital Universitario Dr. José Eleuterio Gonzalez
Monterrey, Nuevo León, 64460, Mexico
Centro de Estudios Clínicos y Especialidades Médicas
Monterrey, Nuevo León, 64620, Mexico
Centro de Alta Especialidad en Reumatologia e Investigación del Potosí
San Luis Potosí City, San Luís Potosí, 78213, Mexico
Centro Especializado en Investigación Clínica
Boca del Río, Veracruz, 94290, Mexico
Centro Peninsular de Investigacion Clinica S.C.P.
Mérida, Yucatán, 97000, Mexico
Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
Durango, 34000, Mexico
Phylasis Clinicas Research S de RL de CV
Estado de México, 54769, Mexico
SMIQ
Querétaro, 76090, Mexico
Centro de Atención e Investigación Cardiovascular del Potosí, S.C.
San Luis Potosí City, 78200, Mexico
INBIOMEDYC Toluca
Toluca, 50130, Mexico
Unidad de Enfermedades Reumaticas y Cronico Degenerativas
Torreón, 27000, Mexico
Clinica Santa Monica
Lima, 15046, Peru
Hospital Nacional Cayetano Heredia
Lima, 15102, Peru
ABK Reuma S.R.L. - Medicentro Biociencias
Pueblo Libre, 15084, Peru
Clinica Vesalio
San Borja, 15036, Peru
Hospital de Apoyo Maria Auxiliadora
San Juán de Miraflores, 15801, Peru
Clínica Médica Cayetano Heredia
San Martín de Porres, 15102, Peru
Mindful Medical Research
San Juan, 00918, Puerto Rico
Related Publications (2)
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.
PMID: 32497440DERIVEDFleischmann 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.
PMID: 32185745DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Information Call Center
- Organization
- Mallinckrodt
Study Officials
- STUDY DIRECTOR
Clinical Team Leader
Mallinckrodt Pharmaceutical
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Part 1: Open Label ; Part 2: Double-blind
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 26, 2016
First Posted
September 29, 2016
Study Start
November 7, 2016
Primary Completion
October 17, 2018
Study Completion
February 13, 2019
Last Updated
March 31, 2020
Results First Posted
March 23, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share