Use of Acthar in Rheumatoid Arthritis (RA) Related Flares

Use of Acthar in Rheumatoid Arthritis Related Flares

This is a Rheumatoid Arthritis (RA) study. The purpose of this research study is to determine in RA flare, whether musculoskeletal ultrasound (MSUS) inflammatory scores and/or disease activity scores improve with Acthar treatment.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis (RA)
• Intervention / Treatment: Drug: Acthar

Detailed Description

Participants with active RA flair will be assigned to take on one of two Acthar doses, either 40 units per week or 80 units twice a week. Both arms will be taking the drug for 4 weeks. Each participant will be coming back for visits at 2 weeks, 1 month and 3 months after the initial baseline visit. During these visits the following information will be collected: MSUS of joints, DAS28, and Health Assessment Questionnaire-Disability Index (HAQ-DI). Participants will also be asked to fill out a questionnaire about their health status.

Efficacy of Acthar to decrease evidence of MSUS synovitis and disease activity measures will be analyzed using the above mentioned instruments, as well as Acthar's ability to prevent the necessity to change patients' RA treatment regimen.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • UCLA David Geffen School of Medicine, Division of Rheumatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patient must meet 1987 ACR criteria
2. Age > 18 years of age
3. Baseline DAS28/Erythrocyte Sedimentation Rate (ESR) >=3.2
4. Stable concomitant Disease Modifying Anti-Rheumatic Drugs (DMARDs)
5. Stable prednisone <10mg or equivalent
6. Power Doppler score of >=10

Exclusion Criteria:

1. Prior treatment with Acthar in the past 2mos
2. Meet one of the above RA flare requirements
3. Subjects who have received live or live attenuated vaccines within 6 weeks prior to the first dose of study drug (or the zoster vaccine)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 40 Units; 40 units of Acthar per week	Drug: Acthar; Injections will be self administered; Other Names: Repository corticotropin injection
Active Comparator: 80 Units; 80 units of Acthar twice per week	Drug: Acthar; Injections will be self administered; Other Names: Repository corticotropin injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DAS28	The DAS28 score is a measure of the participant's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], participant's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. DAS28 equals (=) (0.56 multiplied by [*] the square root [√] of TJC) plus (+) (0.28 * √ of SJC) + (0.70 * the natural logarithm [ln] ESR in millimeters per hour [mm/h]) + (0.014 * participant's global assessment of disease activity). DAS28 Remission is defined as a DAS28 score <2.6.	Baseline to 4 Weeks
Power Doppler Ultrasound Score	34 joints will be evaluated using a 0 to 3 point scale for each joint and the sum of these represents PDUS. The Power Doppler Synovitis Score (PDUS) ranges from 0 to 102. Scores of 0 indicate the least amount of inflammation of the joint while scores of 3 indicate the most amount of inflammation. A higher value of the total score for PDUS represents more severe disease level.	Baseline to 4 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ultrasound Grey Scale Synovial Hypertrophy Score	34 joints will be evaluated using a 0 to 3 point scale for each joint and the sum of these represents GSUS. The grey scale synovial hypertrophy score (GSUS) ranges from 0 to 102. Scores of 0 indicate the least amount of inflammation of the joint while scores of 3 indicate the most amount of inflammation. A higher value of the total score for GSUS represents more severe disease level.	Baseline to 4 Weeks
HAQ-DI	The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain divided by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0, with higher scores indicating worse function.	Baseline to 4 Weeks

Collaborators and Investigators

• Sponsor: Veena Ranganath, MD, MS
• Collaborators: Mallinckrodt
• Investigators: Principal Investigator: Veena K Ranganath, M.D., M.S., University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2017
• Primary Completion (Actual): May 6, 2025
• Study Completion (Actual): May 20, 2025

Study Registration Dates

• First Submitted: September 1, 2015
• First Submitted That Met QC Criteria: September 3, 2015
• First Posted (Estimated): September 4, 2015

Study Record Updates

• Last Update Posted (Actual): August 11, 2026
• Last Update Submitted That Met QC Criteria: July 17, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Rheumatoid arthritis (RA); Musculoskeletal ultrasound (MSUS)
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin and Connective Tissue Diseases; Arthritis, Rheumatoid; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Hypothalamic Hormones; Peptide Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins; Pituitary Hormones; Pituitary Hormones, Anterior; Melanocortins; Pro-Opiomelanocortin; Adrenocorticotropic Hormone
• Other Study ID Numbers: Acthar in Rheumatoid Arthritis

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes