Clinical trial NCT02919761: Safety and Effectiveness of Acthar Gel in Participants With Rheumatoid Arthritis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Arthritis, Rheumatoid
Keywords: Persistent disease activity
Lead sponsor: Mallinckrodt
Sponsor class: INDUSTRY
First posted: 2016-09-29
Enrollment: 259
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Part 1: Single Group; Part 2: Parallel
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Part 1: Number of Participants With Low Disease Activity (LDA) by Visit
timeFrame: Baseline to Week 12
measure: Part 2: Number of Participants Who Maintained Low Disease Activity by Visit
timeFrame: Week 12 to Week 24
Secondary outcomes:
measure: Part 1: Swollen Joint Count by Visit
timeFrame: Baseline to Week 12
measure: Part 2: Swollen Joint Count by Visit During Part 2
timeFrame: Baseline, Week 12 to Week 24
measure: Part 1: Tender Joint Count by Visit
timeFrame: Baseline to Week 12
measure: Part 2: Tender Joint Count by Visit
timeFrame: Baseline, Week 12 to Week 24
measure: Part 1: Patient-Reported General Health by Visit
timeFrame: Baseline to Week 12
measure: Part 2: Patient-Reported General Health by Visit
timeFrame: Baseline, Week 12 to Week 24
measure: Part 1: Erythrocyte Sedimentation Rate (ESR) by Visit
timeFrame: Baseline to Week 12
measure: Part 2: Erythrocyte Sedimentation Rate (ESR) by Visit
timeFrame: Baseline, Week 12 to Week 24
measure: Part 1: Patient's Global Assessment of Pain by Visit
timeFrame: Baseline to Week 12
measure: Part 2: Patient's Global Assessment of Pain by Visit
timeFrame: Baseline, Week 12 to Week 24
measure: Part 1: Physician's Global Assessment of Disease Activities by Visit
timeFrame: Baseline to Week 12
measure: Part 2: Physician's Global Assessment of Disease Activities by Visit
timeFrame: Week 12 to Week 24
Other outcomes:
Locations:
city: San Leandro
country: United States
facility: East Bay Rheumatology Medical Group
state: California
city: Upland
country: United States
facility: Inland Rheumatology Clinical Trials
state: California
city: Boynton Beach
country: United States
facility: Orthopedic Research Institute
state: Florida
city: Clearwater
country: United States
facility: Clinical Research of West Florida
state: Florida
city: Gainesville
country: United States
facility: Southeastern Integrated Medical, PL, d/b/a Florida Medical Research
state: Florida
city: Hialeah
country: United States
facility: Indago Research and Health Center
state: Florida
city: Homestead
country: United States
facility: Homestead Associates in Research
state: Florida
city: Miami Lakes
country: United States
facility: San Marcus Research Clinic
state: Florida
city: Miami
country: United States
facility: Pharmax Research Clinic
state: Florida
city: Miami
country: United States
facility: Suncoast Research Group, LLC
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research
state: Florida
city: Orlando
country: United States
facility: Omega Research Consultants-DeBary
state: Florida
city: Ormond Beach
country: United States
facility: Millennium Research
state: Florida
city: Tampa
country: United States
facility: Clinical Research of West Florida
state: Florida
city: Atlanta
country: United States
facility: Arthritis & Rheumatology of Georgia, PC
state: Georgia
city: Stockbridge
country: United States
facility: Arthritis Research and Treatment Center
state: Georgia
city: Monroe
country: United States
facility: Arthritis and Diabetes Clinic, Inc.
state: Louisiana
city: Lansing
country: United States
facility: June DO, PC
state: Michigan
city: Lincoln
country: United States
facility: Physician Research Collaboration, LLC
state: Nebraska
city: Charlotte
country: United States
facility: DJL Clinical Research
state: North Carolina
city: Columbia
country: United States
facility: Columbia Arthritis Center
state: South Carolina
city: Jackson
country: United States
facility: West Tennessee Research Institute
state: Tennessee
city: Memphis
country: United States
facility: Ramesh C. Gupta, MD
state: Tennessee
city: Cypress
country: United States
facility: Northwest Med Care
state: Texas
city: Houston
country: United States
facility: Rheumatic Disease Clinical Research Center
state: Texas
city: Houston
country: United States
facility: Accurate Clinical Research
state: Texas
city: Houston
country: United States
facility: Laila Hassan, MD, PA
state: Texas
city: Houston
country: United States
facility: Pioneer Research Solutions
state: Texas
city: Mesquite
country: United States
facility: Southwest Rheumatology Research
state: Texas
city: San Antonio
country: United States
facility: Sun Research Institute
state: Texas
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Aprillus Asistencia e Investigación
state: Buenos Aires
city: Ramos Mejía
country: Argentina
facility: DIM Clínica Privada
state: Buenos Aires
city: San Miguel De Tucumán
country: Argentina
facility: Centro de Investigaciones Reumatológicas
state: Tucuman
city: San Juan
country: Argentina
facility: Centro Polivalente de Asistencia e Investigación Clínica CER San Juan
city: Tijuana
country: Mexico
facility: Centro de Investigacion del Noroeste, S.C.
state: Baja California
city: Mexico
country: Mexico
facility: Hospital De Jesus
state: Distrito Federal
city: Mexico
country: Mexico
facility: Consultorio de Reumatología
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde
state: Jalisco
city: Guadalajara
country: Mexico
facility: Clinica de Investigacion en Reumatologia y Obesidad
state: Jalisco
city: Zapopan
country: Mexico
facility: Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.
state: Jalisco
city: Cuernavaca
country: Mexico
facility: Consultorio Privado del Dr. Miguel Cortes Hernandez
state: Morelos
city: Monterrey
country: Mexico
facility: Centro de Estudios Clínicos y Especialidades Médicas
state: Nuevo LEON
city: Monterrey
country: Mexico
facility: Hospital Universitario Dr. José Eleuterio Gonzalez
state: Nuevo León
city: San Luis Potosí
country: Mexico
facility: Centro de Alta Especialidad en Reumatologia e Investigación del Potosí
state: San Luís Potosí
city: Boca Del Río
country: Mexico
facility: Centro Especializado en Investigación Clínica
state: Veracruz
city: Mérida
country: Mexico
facility: Centro Peninsular de Investigacion Clinica S.C.P.
state: Yucatan
city: Durango
country: Mexico
facility: Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
city: Estado de México
country: Mexico
facility: Phylasis Clinicas Research S de RL de CV
city: Querétaro
country: Mexico
facility: SMIQ
city: San Luis Potosí
country: Mexico
facility: Centro de Atención e Investigación Cardiovascular del Potosí, S.C.
city: Toluca
country: Mexico
facility: INBIOMEDYC Toluca
city: Torreon
country: Mexico
facility: Unidad de Enfermedades Reumaticas y Cronico Degenerativas
city: Lima
country: Peru
facility: Clinica Santa Monica
city: Lima
country: Peru
facility: Hospital Nacional Cayetano Heredia
city: Pueblo Libre
country: Peru
facility: ABK Reuma S.R.L. - Medicentro Biociencias
city: San Borja
country: Peru
facility: Clinica Vesalio
city: San Juán De Miraflores
country: Peru
facility: Hospital de Apoyo Maria Auxiliadora
city: San Martín De Porres
country: Peru
facility: Clínica Médica Cayetano Heredia
city: San Juan
country: Puerto Rico
facility: Mindful Medical Research
Study officials:
affiliation: Mallinckrodt Pharmaceutical
name: Clinical Team Leader
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.