Safety and Effectiveness of Acthar Gel in Participants With Rheumatoid Arthritis

Arthritis, Rheumatoid Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02919761
• Other study ID #: MNK14294063
• Status: Completed
• Phase: Phase 4
• Start date: November 7, 2016
• Est. completion date: February 13, 2019

Study information

• Verified date: March 2020
• Source: Mallinckrodt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 259
• Est. completion date: February 13, 2019
• Est. primary completion date: October 17, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid

Intervention

Drug:
• Acthar Gel
80 Units Acthar Gel per 1 mL for subcutaneous injection
• Placebo
Matching placebo 1 mL for subcutaneous injection

Locations

Country	Name	City	State
Argentina	Aprillus Asistencia e Investigación	Ciudad Autónoma de Buenos Aires	Buenos Aires
Argentina	DIM Clínica Privada	Ramos Mejía	Buenos Aires
Argentina	Centro Polivalente de Asistencia e Investigación Clínica CER San Juan	San Juan
Argentina	Centro de Investigaciones Reumatológicas	San Miguel De Tucumán	Tucuman
Mexico	Centro Especializado en Investigación Clínica	Boca Del Río	Veracruz
Mexico	Consultorio Privado del Dr. Miguel Cortes Hernandez	Cuernavaca	Morelos
Mexico	Instituto de Investigaciones Aplicadas a la Neurociencia A.C.	Durango
Mexico	Phylasis Clinicas Research S de RL de CV	Estado de México
Mexico	Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde	Guadalajara	Jalisco
Mexico	Clinica de Investigacion en Reumatologia y Obesidad	Guadalajara	Jalisco
Mexico	Centro Peninsular de Investigacion Clinica S.C.P.	Mérida	Yucatan
Mexico	Consultorio de Reumatología	Mexico	Distrito Federal
Mexico	Hospital De Jesus	Mexico	Distrito Federal
Mexico	Centro de Estudios Clínicos y Especialidades Médicas	Monterrey	Nuevo LEON
Mexico	Hospital Universitario Dr. José Eleuterio Gonzalez	Monterrey	Nuevo León
Mexico	SMIQ	Querétaro
Mexico	Centro de Alta Especialidad en Reumatologia e Investigación del Potosí	San Luis Potosí	San Luís Potosí
Mexico	Centro de Atención e Investigación Cardiovascular del Potosí, S.C.	San Luis Potosí
Mexico	Centro de Investigacion del Noroeste, S.C.	Tijuana	Baja California
Mexico	INBIOMEDYC Toluca	Toluca
Mexico	Unidad de Enfermedades Reumaticas y Cronico Degenerativas	Torreon
Mexico	Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.	Zapopan	Jalisco
Peru	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
Puerto Rico	Mindful Medical Research	San Juan
United States	Arthritis & Rheumatology of Georgia, PC	Atlanta	Georgia
United States	Orthopedic Research Institute	Boynton Beach	Florida
United States	DJL Clinical Research	Charlotte	North Carolina
United States	Clinical Research of West Florida	Clearwater	Florida
United States	Columbia Arthritis Center	Columbia	South Carolina
United States	Northwest Med Care	Cypress	Texas
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	Accurate Clinical Research	Houston	Texas
United States	Laila Hassan, MD, PA	Houston	Texas
United States	Pioneer Research Solutions	Houston	Texas
United States	Rheumatic Disease Clinical Research Center	Houston	Texas
United States	West Tennessee Research Institute	Jackson	Tennessee
United States	June DO, PC	Lansing	Michigan
United States	Physician Research Collaboration, LLC	Lincoln	Nebraska
United States	Ramesh C. Gupta, MD	Memphis	Tennessee
United States	Southwest Rheumatology Research	Mesquite	Texas
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	Arthritis and Diabetes Clinic, Inc.	Monroe	Louisiana
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	Sun Research Institute	San Antonio	Texas
United States	East Bay Rheumatology Medical Group	San Leandro	California
United States	Arthritis Research and Treatment Center	Stockbridge	Georgia
United States	Clinical Research of West Florida	Tampa	Florida
United States	Inland Rheumatology Clinical Trials	Upland	California

Sponsors (1)

Lead Sponsor	Collaborator
Mallinckrodt

Countries where clinical trial is conducted

United States,  Argentina,  Mexico,  Peru,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part 1: Number of Participants With Low Disease Activity (LDA) by Visit	LDA is defined as DAS28 <3.2.	Baseline to Week 12
Primary	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	Part 1: Swollen Joint Count by Visit	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 Rate	Baseline to Week 12
Secondary	Part 2: Swollen Joint Count by Visit During Part 2	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 Rate	Baseline, Week 12 to Week 24
Secondary	Part 1: Tender Joint Count by Visit	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 Rate	Baseline to Week 12
Secondary	Part 2: Tender Joint Count by Visit	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 Rate	Baseline, Week 12 to Week 24
Secondary	Part 1: Patient-Reported General Health by Visit	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.	Baseline to Week 12
Secondary	Part 2: Patient-Reported General Health by Visit	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.	Baseline, Week 12 to Week 24
Secondary	Part 1: Erythrocyte Sedimentation Rate (ESR) by Visit	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 Rate	Baseline to Week 12
Secondary	Part 2: Erythrocyte Sedimentation Rate (ESR) by Visit	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 Rate	Baseline, Week 12 to Week 24
Secondary	Part 1: Patient's Global Assessment of Pain by Visit	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.	Baseline to Week 12
Secondary	Part 2: Patient's Global Assessment of Pain by Visit	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.	Baseline, Week 12 to Week 24
Secondary	Part 1: Physician's Global Assessment of Disease Activities by Visit	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.	Baseline to Week 12
Secondary	Part 2: Physician's Global Assessment of Disease Activities by Visit	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.	Week 12 to Week 24