Safety and Effectiveness of Acthar Gel in Participants With Rheumatoid Arthritis
- Registration Number
- NCT02919761
- Lead Sponsor
- Mallinckrodt
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 259
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 2: Placebo Placebo Participants receive Placebo 1 mL twice weekly for an additional 12 weeks Part 1: All Enrolled Participants Acthar Gel All participants receive Acthar Gel 1 mL twice weekly for 12 weeks Part 2: Acthar Gel Acthar Gel Participants receive Acthar Gel 1 mL twice weekly for an additional 12 weeks
- Primary Outcome Measures
Name Time Method Part 1: Number of Participants With Low Disease Activity (LDA) by Visit Baseline to Week 12 LDA is defined as DAS28 \<3.2.
Part 2: Number of Participants Who Maintained Low Disease Activity by Visit Week 12 to Week 24 Low disease activity is defined as DAS28 \<3.2.
- Secondary Outcome Measures
Name Time Method Part 1: Patient-Reported General Health by Visit Baseline to Week 12 Participants rate their general health on a 100 mm visual analogue scale (VAS), where 0=best general health and 100=worst general health.
A lower score indicates better general health.Part 1: Erythrocyte Sedimentation Rate (ESR) by Visit Baseline to Week 12 The ESR is the rate at which red blood cells (in whole blood that has not clotted) fall to the bottom of the tube over a period of one hour.
The clear liquid above the red blood cells is measured in millimeters after one hour (mm/hr).
The normal range for ESR results is 1-13 mm/hr for males and 1/20 mm/hr for females.
The ESR is a common test for inflammation and used to derive the DAS28.
The DAS28 is a composite score derived from the following assessments:
* Swollen Joint Count
* Tender Joint Count
* Patient's Global Health
* Erythrocyte Sedimentation RatePart 2: Erythrocyte Sedimentation Rate (ESR) by Visit Baseline, Week 12 to Week 24 The ESR is the rate at which red blood cells (in whole blood that has not clotted) fall to the bottom of the tube over a period of one hour.
The clear liquid above the red blood cells is measured in millimeters after one hour (mm/hr).
The normal range for ESR results is 1-13 mm/hr for males and 1/20 mm/hr for females.
The ESR is a common test for inflammation and used to derive the DAS28.
The DAS28 is a composite score derived from the following assessments:
* Swollen Joint Count
* Tender Joint Count
* Patient's Global Health
* Erythrocyte Sedimentation RatePart 1: Swollen Joint Count by Visit Baseline to Week 12 The investigator counts the number of swollen joints used to calculate the Disease Activity Score (DAS28-ESR, DAS28)
The DAS28 is a composite score derived from the following assessments:
* Swollen Joint Count
* Tender Joint Count
* Patient's Global Health
* Erythrocyte Sedimentation RatePart 2: Swollen Joint Count by Visit During Part 2 Baseline, Week 12 to Week 24 The investigator counts the number of swollen joints used to calculate the Disease Activity Score (DAS28-ESR/DAS28)
The DAS28 is a composite score derived from the following assessments:
* Swollen Joint Count
* Tender Joint Count
* Patient's Global Health
* Erythrocyte Sedimentation RatePart 1: Tender Joint Count by Visit Baseline to Week 12 The investigator counts the number of tender joints used to calculate the Disease Activity Score (DAS28-ESR, DAS28)
The DAS28 is a composite score derived from the following assessments:
* Swollen Joint Count
* Tender Joint Count
* Patient's Global Health
* Erythrocyte Sedimentation RatePart 2: Tender Joint Count by Visit Baseline, Week 12 to Week 24 The investigator counts the number of tender joints used to calculate the Disease Activity Score (DAS28-ESR, DAS28)
The DAS28 is a composite score derived from the following assessments:
* Swollen Joint Count
* Tender Joint Count
* Patient's Global Health
* Erythrocyte Sedimentation RatePart 2: Patient-Reported General Health by Visit Baseline, Week 12 to Week 24 Participants rate their general health on a 100 mm visual analogue scale (VAS), where 0=best general health and 100=worst general health.
A lower score indicates better general health.Part 1: Physician's Global Assessment of Disease Activities by Visit Baseline to Week 12 The physician rates the participant's disease activity on a 100 mm visual analogue scale, where 0=very good and 100=very bad. Lower scores indicate improvement.
Part 1: Patient's Global Assessment of Pain by Visit Baseline to Week 12 Patients rate their pain on a 100 mm VAS, where 0=no pain and 100=pain as bad as it could be. Higher scores indicate more pain.
Part 2: Patient's Global Assessment of Pain by Visit Baseline, Week 12 to Week 24 Patients rate their pain on a 100 mm VAS, where 0=no pain and 100=pain as bad as it could be. Higher scores indicate more pain.
Part 2: Physician's Global Assessment of Disease Activities by Visit Week 12 to Week 24 The physician rates the participant's disease activity on a 100 mm visual analogue scale, where 0=very good and 100=very bad. Lower scores indicate improvement.
Trial Locations
- Locations (58)
June DO, PC
🇺🇸Lansing, Michigan, United States
Physician Research Collaboration, LLC
🇺🇸Lincoln, Nebraska, United States
SMIQ
🇲🇽Querétaro, Mexico
Clinica Santa Monica
🇵🇪Lima, Peru
Centro de Estudios Clínicos y Especialidades Médicas
🇲🇽Monterrey, Nuevo LEON, Mexico
Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
🇲🇽Durango, Mexico
Hospital de Apoyo Maria Auxiliadora
🇵🇪San Juán De Miraflores, Peru
Clinica de Investigacion en Reumatologia y Obesidad
🇲🇽Guadalajara, Jalisco, Mexico
Consultorio Privado del Dr. Miguel Cortes Hernandez
🇲🇽Cuernavaca, Morelos, Mexico
Hospital Universitario Dr. José Eleuterio Gonzalez
🇲🇽Monterrey, Nuevo León, Mexico
Mindful Medical Research
🇵🇷San Juan, Puerto Rico
Centro de Alta Especialidad en Reumatologia e Investigación del Potosí
🇲🇽San Luis Potosí, San Luís Potosí, Mexico
Suncoast Research Group, LLC
🇺🇸Miami, Florida, United States
East Bay Rheumatology Medical Group
🇺🇸San Leandro, California, United States
Clinical Research of West Florida
🇺🇸Tampa, Florida, United States
Pharmax Research Clinic
🇺🇸Miami, Florida, United States
Accurate Clinical Research
🇺🇸Houston, Texas, United States
Pioneer Research Solutions
🇺🇸Houston, Texas, United States
Rheumatic Disease Clinical Research Center
🇺🇸Houston, Texas, United States
Laila Hassan, MD, PA
🇺🇸Houston, Texas, United States
Orthopedic Research Institute
🇺🇸Boynton Beach, Florida, United States
Inland Rheumatology Clinical Trials
🇺🇸Upland, California, United States
San Marcus Research Clinic
🇺🇸Miami Lakes, Florida, United States
Suncoast Clinical Research
🇺🇸New Port Richey, Florida, United States
Homestead Associates in Research
🇺🇸Homestead, Florida, United States
Arthritis & Rheumatology of Georgia, PC
🇺🇸Atlanta, Georgia, United States
Arthritis Research and Treatment Center
🇺🇸Stockbridge, Georgia, United States
Ramesh C. Gupta, MD
🇺🇸Memphis, Tennessee, United States
Northwest Med Care
🇺🇸Cypress, Texas, United States
Columbia Arthritis Center
🇺🇸Columbia, South Carolina, United States
DJL Clinical Research
🇺🇸Charlotte, North Carolina, United States
Sun Research Institute
🇺🇸San Antonio, Texas, United States
Aprillus Asistencia e Investigación
🇦🇷Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Centro Polivalente de Asistencia e Investigación Clínica CER San Juan
🇦🇷San Juan, Argentina
Southwest Rheumatology Research
🇺🇸Mesquite, Texas, United States
Centro de Investigaciones Reumatológicas
🇦🇷San Miguel De Tucumán, Tucuman, Argentina
Hospital De Jesus
🇲🇽Mexico, Distrito Federal, Mexico
Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde
🇲🇽Guadalajara, Jalisco, Mexico
DIM Clínica Privada
🇦🇷Ramos Mejía, Buenos Aires, Argentina
Centro de Investigacion del Noroeste, S.C.
🇲🇽Tijuana, Baja California, Mexico
Centro Especializado en Investigación Clínica
🇲🇽Boca Del Río, Veracruz, Mexico
Centro de Atención e Investigación Cardiovascular del Potosí, S.C.
🇲🇽San Luis Potosí, Mexico
Indago Research and Health Center
🇺🇸Hialeah, Florida, United States
Millennium Research
🇺🇸Ormond Beach, Florida, United States
West Tennessee Research Institute
🇺🇸Jackson, Tennessee, United States
Arthritis and Diabetes Clinic, Inc.
🇺🇸Monroe, Louisiana, United States
ABK Reuma S.R.L. - Medicentro Biociencias
🇵🇪Pueblo Libre, Peru
Clinica Vesalio
🇵🇪San Borja, Peru
Clínica Médica Cayetano Heredia
🇵🇪San Martín De Porres, Peru
INBIOMEDYC Toluca
🇲🇽Toluca, Mexico
Centro Peninsular de Investigacion Clinica S.C.P.
🇲🇽Mérida, Yucatan, Mexico
Phylasis Clinicas Research S de RL de CV
🇲🇽Estado de México, Mexico
Unidad de Enfermedades Reumaticas y Cronico Degenerativas
🇲🇽Torreon, Mexico
Hospital Nacional Cayetano Heredia
🇵🇪Lima, Peru
Consultorio de Reumatología
🇲🇽Mexico, Distrito Federal, Mexico
Southeastern Integrated Medical, PL, d/b/a Florida Medical Research
🇺🇸Gainesville, Florida, United States
Omega Research Consultants-DeBary
🇺🇸Orlando, Florida, United States
Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.
🇲🇽Zapopan, Jalisco, Mexico