Safety and Effectiveness of Acthar Gel in Participants With Rheumatoid Arthritis

Phase 4

Completed

Conditions: Arthritis, Rheumatoid

Interventions: Drug: Placebo
Drug: Acthar Gel

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

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

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 Rate
Part 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 Rate
Part 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 Rate
Part 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 Rate
Part 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 Rate
Part 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 Rate
Part 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): East Bay Rheumatology Medical Group
🇺🇸
San Leandro, California, United States
Inland Rheumatology Clinical Trials
🇺🇸
Upland, California, United States
Orthopedic Research Institute
🇺🇸
Boynton Beach, Florida, United States
Clinical Research of West Florida
🇺🇸
Tampa, Florida, 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
San Marcus Research Clinic
🇺🇸
Miami Lakes, Florida, United States
Pharmax Research Clinic
🇺🇸
Miami, Florida, United States
Suncoast Research Group, LLC
🇺🇸
Miami, Florida, United States
Scroll for more (48 remaining)
East Bay Rheumatology Medical Group
🇺🇸San Leandro, California, United States