Phase 4 Completed N=259 Randomized Double-blind Treatment

Safety and Effectiveness of Acthar Gel in Participants With Rheumatoid Arthritis

Arthritis, Rheumatoid

Source: ClinicalTrials.gov NCT02919761 ↗

Enrolled (actual)

259

Serious AEs

0.7%

Results posted

Mar 2020

Primary outcomePrimary: Part 1: Number of Participants With Low Disease Activity (LDA) by Visit — 0; 17; 37; 163 Participants — p==0.242

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Part 1: Number of Participants With Low Disease Activity (LDA) by Visit	0; 17; 37; 163	=0.242
PRIMARY Part 2: Number of Participants Who Maintained Low Disease Activity by Visit	77; 75; 58; 53; 61; 48	=0.313
SECONDARY Part 1: Swollen Joint Count by Visit	10.9; 5.6; 4.0; 2.8	—
SECONDARY Part 2: Swollen Joint Count by Visit During Part 2	10.1; 9.7; 0.9; 0.9; 1.7; 1.1	—
SECONDARY Part 1: Tender Joint Count by Visit	14.7; 7.7; 5.7; 3.9	—
SECONDARY Part 2: Tender Joint Count by Visit	13.5; 13.5; 1.5; 1.4; 2.6; 1.6	—
SECONDARY Part 1: Patient-Reported General Health by Visit	59.8; 45.1; 37.8; 27.0	—
SECONDARY Part 2: Patient-Reported General Health by Visit	13.5; 13.5; 15.4; 18.8; 17.2; 19.6	—
SECONDARY Part 1: Erythrocyte Sedimentation Rate (ESR) by Visit	43.6; 35.4; 30.6; 24.0	—
SECONDARY Part 2: Erythrocyte Sedimentation Rate (ESR) by Visit	42.2; 40.3; 15.2; 15.8; 19.6; 17.7	—
SECONDARY Part 1: Patient's Global Assessment of Pain by Visit	64.9; 44.1; 37.3; 27.5	—
SECONDARY Part 2: Patient's Global Assessment of Pain by Visit	62.8; 65.7; 17.0; 18.9; 21.6; 22.1	—
SECONDARY Part 1: Physician's Global Assessment of Disease Activities by Visit	64.3; 36.1; 29.0; 21.0	—
SECONDARY Part 2: Physician's Global Assessment of Disease Activities by Visit	11.5; 12.9; 15.5; 13.3; 15.9; 12.4	—

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

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Data sourced from ClinicalTrials.gov (NCT02919761). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.