Safety and Effectiveness of Acthar Gel in Participants With Rheumatoid Arthritis

Phase 4CompletedNCT02919761

Mallinckrodt259 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

259

Conditions

Arthritis, Rheumatoid

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (59)

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

Clearwater, Florida, United States

Southeastern Integrated Medical, PL, d/b/a Florida Medical Research

Gainesville, Florida, United States

Outcomes

Primary Outcomes

Part 1: Number of Participants With Low Disease Activity (LDA) by Visit

LDA is defined as DAS28 \<3.2.

Time frame: Baseline to Week 12

Part 2: Number of Participants Who Maintained Low Disease Activity by Visit

Low disease activity is defined as DAS28 \<3.2.

Time frame: Week 12 to Week 24

Secondary Outcomes

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

Time frame: Baseline to Week 12

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

Time frame: Baseline, Week 12 to Week 24

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

Time frame: Baseline to Week 12

Part 2: Tender Joint Count by Visit

Time frame: Baseline, Week 12 to Week 24

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.

Time frame: Baseline to Week 12

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.

Time frame: Baseline, Week 12 to Week 24

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

Time frame: Baseline to Week 12

Part 2: Erythrocyte Sedimentation Rate (ESR) by Visit

Time frame: Baseline, Week 12 to Week 24

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.

Time frame: Baseline to Week 12

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.

Time frame: Baseline, Week 12 to Week 24

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.

Time frame: Baseline to Week 12

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.

Time frame: Week 12 to Week 24