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Safety and Effectiveness of Acthar Gel in Participants With Rheumatoid Arthritis

Primary Purpose

Arthritis, Rheumatoid

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Acthar Gel
Placebo
Sponsored by
Mallinckrodt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthritis, Rheumatoid focused on measuring Persistent disease activity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • East Bay Rheumatology Medical Group
  • Inland Rheumatology Clinical Trials
  • Orthopedic Research Institute
  • Clinical Research of West Florida
  • Southeastern Integrated Medical, PL, d/b/a Florida Medical Research
  • Indago Research and Health Center
  • Homestead Associates in Research
  • San Marcus Research Clinic
  • Pharmax Research Clinic
  • Suncoast Research Group, LLC
  • Suncoast Clinical Research
  • Omega Research Consultants-DeBary
  • Millennium Research
  • Clinical Research of West Florida
  • Arthritis & Rheumatology of Georgia, PC
  • Arthritis Research and Treatment Center
  • Arthritis and Diabetes Clinic, Inc.
  • June DO, PC
  • Physician Research Collaboration, LLC
  • DJL Clinical Research
  • Columbia Arthritis Center
  • West Tennessee Research Institute
  • Ramesh C. Gupta, MD
  • Northwest Med Care
  • Rheumatic Disease Clinical Research Center
  • Accurate Clinical Research
  • Laila Hassan, MD, PA
  • Pioneer Research Solutions
  • Southwest Rheumatology Research
  • Sun Research Institute
  • Aprillus Asistencia e Investigación
  • DIM Clínica Privada
  • Centro de Investigaciones Reumatológicas
  • Centro Polivalente de Asistencia e Investigación Clínica CER San Juan
  • Centro de Investigacion del Noroeste, S.C.
  • Hospital De Jesus
  • Consultorio de Reumatología
  • Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde
  • Clinica de Investigacion en Reumatologia y Obesidad
  • Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.
  • Consultorio Privado del Dr. Miguel Cortes Hernandez
  • Centro de Estudios Clínicos y Especialidades Médicas
  • Hospital Universitario Dr. José Eleuterio Gonzalez
  • Centro de Alta Especialidad en Reumatologia e Investigación del Potosí
  • Centro Especializado en Investigación Clínica
  • Centro Peninsular de Investigacion Clinica S.C.P.
  • Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
  • Phylasis Clinicas Research S de RL de CV
  • SMIQ
  • Centro de Atención e Investigación Cardiovascular del Potosí, S.C.
  • INBIOMEDYC Toluca
  • Unidad de Enfermedades Reumaticas y Cronico Degenerativas
  • Clinica Santa Monica
  • Hospital Nacional Cayetano Heredia
  • ABK Reuma S.R.L. - Medicentro Biociencias
  • Clinica Vesalio
  • Hospital de Apoyo Maria Auxiliadora
  • Clínica Médica Cayetano Heredia
  • Mindful Medical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Part 1: All Enrolled Participants

Part 2: Acthar Gel

Part 2: Placebo

Arm Description

All participants receive Acthar Gel 1 mL twice weekly for 12 weeks

Participants receive Acthar Gel 1 mL twice weekly for an additional 12 weeks

Participants receive Placebo 1 mL twice weekly for an additional 12 weeks

Outcomes

Primary Outcome Measures

Part 1: Number of Participants With Low Disease Activity (LDA) by Visit
LDA is defined as DAS28 <3.2.
Part 2: Number of Participants Who Maintained Low Disease Activity by Visit
Low disease activity is defined as DAS28 <3.2.

Secondary Outcome Measures

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
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
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
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
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.
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.
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
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
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.
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.
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.
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.

Full Information

First Posted
September 26, 2016
Last Updated
March 20, 2020
Sponsor
Mallinckrodt
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1. Study Identification

Unique Protocol Identification Number
NCT02919761
Brief Title
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

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
November 7, 2016 (Actual)
Primary Completion Date
October 17, 2018 (Actual)
Study Completion Date
February 13, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mallinckrodt

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Rheumatoid
Keywords
Persistent disease activity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Part 1: Single Group; Part 2: Parallel
Masking
ParticipantInvestigator
Masking Description
Part 1: Open Label ; Part 2: Double-blind
Allocation
Randomized
Enrollment
259 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part 1: All Enrolled Participants
Arm Type
Experimental
Arm Description
All participants receive Acthar Gel 1 mL twice weekly for 12 weeks
Arm Title
Part 2: Acthar Gel
Arm Type
Experimental
Arm Description
Participants receive Acthar Gel 1 mL twice weekly for an additional 12 weeks
Arm Title
Part 2: Placebo
Arm Type
Placebo Comparator
Arm Description
Participants receive Placebo 1 mL twice weekly for an additional 12 weeks
Intervention Type
Drug
Intervention Name(s)
Acthar Gel
Other Intervention Name(s)
Acthar, H.P. Acthar Gel
Intervention Description
80 Units Acthar Gel per 1 mL for subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Matching Placebo
Intervention Description
Matching placebo 1 mL for subcutaneous injection
Primary Outcome Measure Information:
Title
Part 1: Number of Participants With Low Disease Activity (LDA) by Visit
Description
LDA is defined as DAS28 <3.2.
Time Frame
Baseline to Week 12
Title
Part 2: Number of Participants Who Maintained Low Disease Activity by Visit
Description
Low disease activity is defined as DAS28 <3.2.
Time Frame
Week 12 to Week 24
Secondary Outcome Measure Information:
Title
Part 1: Swollen Joint Count by Visit
Description
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
Time Frame
Baseline to Week 12
Title
Part 2: Swollen Joint Count by Visit During Part 2
Description
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
Time Frame
Baseline, Week 12 to Week 24
Title
Part 1: Tender Joint Count by Visit
Description
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
Time Frame
Baseline to Week 12
Title
Part 2: Tender Joint Count by Visit
Description
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
Time Frame
Baseline, Week 12 to Week 24
Title
Part 1: Patient-Reported General Health by Visit
Description
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.
Time Frame
Baseline to Week 12
Title
Part 2: Patient-Reported General Health by Visit
Description
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.
Time Frame
Baseline, Week 12 to Week 24
Title
Part 1: Erythrocyte Sedimentation Rate (ESR) by Visit
Description
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
Time Frame
Baseline to Week 12
Title
Part 2: Erythrocyte Sedimentation Rate (ESR) by Visit
Description
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
Time Frame
Baseline, Week 12 to Week 24
Title
Part 1: Patient's Global Assessment of Pain by Visit
Description
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.
Time Frame
Baseline to Week 12
Title
Part 2: Patient's Global Assessment of Pain by Visit
Description
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.
Time Frame
Baseline, Week 12 to Week 24
Title
Part 1: Physician's Global Assessment of Disease Activities by Visit
Description
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.
Time Frame
Baseline to Week 12
Title
Part 2: Physician's Global Assessment of Disease Activities by Visit
Description
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.
Time Frame
Week 12 to Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Team Leader
Organizational Affiliation
Mallinckrodt Pharmaceutical
Official's Role
Study Director
Facility Information:
Facility Name
East Bay Rheumatology Medical Group
City
San Leandro
State/Province
California
ZIP/Postal Code
94578
Country
United States
Facility Name
Inland Rheumatology Clinical Trials
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Orthopedic Research Institute
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33472
Country
United States
Facility Name
Clinical Research of West Florida
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Southeastern Integrated Medical, PL, d/b/a Florida Medical Research
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Indago Research and Health Center
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Homestead Associates in Research
City
Homestead
State/Province
Florida
ZIP/Postal Code
33032
Country
United States
Facility Name
San Marcus Research Clinic
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33015
Country
United States
Facility Name
Pharmax Research Clinic
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Suncoast Research Group, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Facility Name
Suncoast Clinical Research
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Omega Research Consultants-DeBary
City
Orlando
State/Province
Florida
ZIP/Postal Code
32810
Country
United States
Facility Name
Millennium Research
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Clinical Research of West Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
Arthritis & Rheumatology of Georgia, PC
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Arthritis Research and Treatment Center
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
Arthritis and Diabetes Clinic, Inc.
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71203
Country
United States
Facility Name
June DO, PC
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
Physician Research Collaboration, LLC
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68516
Country
United States
Facility Name
DJL Clinical Research
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Columbia Arthritis Center
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29204
Country
United States
Facility Name
West Tennessee Research Institute
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Ramesh C. Gupta, MD
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Northwest Med Care
City
Cypress
State/Province
Texas
ZIP/Postal Code
77429
Country
United States
Facility Name
Rheumatic Disease Clinical Research Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Accurate Clinical Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77034
Country
United States
Facility Name
Laila Hassan, MD, PA
City
Houston
State/Province
Texas
ZIP/Postal Code
77089
Country
United States
Facility Name
Pioneer Research Solutions
City
Houston
State/Province
Texas
ZIP/Postal Code
77099
Country
United States
Facility Name
Southwest Rheumatology Research
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75150
Country
United States
Facility Name
Sun Research Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Aprillus Asistencia e Investigación
City
Ciudad Autónoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1046AAQ
Country
Argentina
Facility Name
DIM Clínica Privada
City
Ramos Mejía
State/Province
Buenos Aires
ZIP/Postal Code
1704
Country
Argentina
Facility Name
Centro de Investigaciones Reumatológicas
City
San Miguel De Tucumán
State/Province
Tucuman
ZIP/Postal Code
T4000BRD
Country
Argentina
Facility Name
Centro Polivalente de Asistencia e Investigación Clínica CER San Juan
City
San Juan
ZIP/Postal Code
J5402DIL
Country
Argentina
Facility Name
Centro de Investigacion del Noroeste, S.C.
City
Tijuana
State/Province
Baja California
ZIP/Postal Code
22010
Country
Mexico
Facility Name
Hospital De Jesus
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
06090
Country
Mexico
Facility Name
Consultorio de Reumatología
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
07760
Country
Mexico
Facility Name
Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44280
Country
Mexico
Facility Name
Clinica de Investigacion en Reumatologia y Obesidad
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44650
Country
Mexico
Facility Name
Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.
City
Zapopan
State/Province
Jalisco
ZIP/Postal Code
45030
Country
Mexico
Facility Name
Consultorio Privado del Dr. Miguel Cortes Hernandez
City
Cuernavaca
State/Province
Morelos
ZIP/Postal Code
62290
Country
Mexico
Facility Name
Centro de Estudios Clínicos y Especialidades Médicas
City
Monterrey
State/Province
Nuevo LEON
ZIP/Postal Code
64620
Country
Mexico
Facility Name
Hospital Universitario Dr. José Eleuterio Gonzalez
City
Monterrey
State/Province
Nuevo León
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Centro de Alta Especialidad en Reumatologia e Investigación del Potosí
City
San Luis Potosí
State/Province
San Luís Potosí
ZIP/Postal Code
78213
Country
Mexico
Facility Name
Centro Especializado en Investigación Clínica
City
Boca Del Río
State/Province
Veracruz
ZIP/Postal Code
94290
Country
Mexico
Facility Name
Centro Peninsular de Investigacion Clinica S.C.P.
City
Mérida
State/Province
Yucatan
ZIP/Postal Code
97000
Country
Mexico
Facility Name
Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
City
Durango
ZIP/Postal Code
34000
Country
Mexico
Facility Name
Phylasis Clinicas Research S de RL de CV
City
Estado de México
ZIP/Postal Code
54769
Country
Mexico
Facility Name
SMIQ
City
Querétaro
ZIP/Postal Code
76090
Country
Mexico
Facility Name
Centro de Atención e Investigación Cardiovascular del Potosí, S.C.
City
San Luis Potosí
ZIP/Postal Code
78200
Country
Mexico
Facility Name
INBIOMEDYC Toluca
City
Toluca
ZIP/Postal Code
50130
Country
Mexico
Facility Name
Unidad de Enfermedades Reumaticas y Cronico Degenerativas
City
Torreon
ZIP/Postal Code
27000
Country
Mexico
Facility Name
Clinica Santa Monica
City
Lima
ZIP/Postal Code
15046
Country
Peru
Facility Name
Hospital Nacional Cayetano Heredia
City
Lima
ZIP/Postal Code
15102
Country
Peru
Facility Name
ABK Reuma S.R.L. - Medicentro Biociencias
City
Pueblo Libre
ZIP/Postal Code
15084
Country
Peru
Facility Name
Clinica Vesalio
City
San Borja
ZIP/Postal Code
15036
Country
Peru
Facility Name
Hospital de Apoyo Maria Auxiliadora
City
San Juán De Miraflores
ZIP/Postal Code
15801
Country
Peru
Facility Name
Clínica Médica Cayetano Heredia
City
San Martín De Porres
ZIP/Postal Code
15102
Country
Peru
Facility Name
Mindful Medical Research
City
San Juan
ZIP/Postal Code
00918
Country
Puerto Rico

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32497440
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.
Results Reference
derived
PubMed Identifier
32185745
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.
Results Reference
derived

Learn more about this trial

Safety and Effectiveness of Acthar Gel in Participants With Rheumatoid Arthritis

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