Use of Acthar in Rheumatoid Arthritis (RA) Related Flares

Phase 4

Recruiting

• Conditions: Rheumatoid Arthritis (RA)
• Interventions: Drug: Acthar

• Registration Number: NCT02541955
• Lead Sponsor: Veena Ranganath, MD, MS

Brief Summary

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.

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, Clinical Disease Activity Index (CDAI), Routine Assessment of Patient Index Data 3 (RAPID3) 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 Timeline

• Study First Submitted: 2015-09-01
• Study First Submitted QC: 2015-09-03
• Study First Posted: 2015-09-04
• Study Start: 2017-07-20
• Status Verified: 2024-05
• Last Update Submitted: 2025-03-28
• Last Update Posted: 2025-04-02
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
40 Units	Acthar	40 units of Acthar per week
80 Units	Acthar	80 units of Acthar twice per week

Primary Outcome Measures

Name	Time	Method
DAS28	Baseline to 2 Weeks	DAS28 will be calculated. The change in the scores will be analyzed between the two groups.
Ultrasound Power Doppler Score	Baseline to 2 Weeks	Using Ultrasound a measure of Power Doppler will be calculated. The change in the scores will be analyzed between the two groups.

Secondary Outcome Measures

Name	Time	Method
Ultrasound Grey Scale Synovial Hypertrophy score	Baseline to 2 Weeks	Using Ultrasound a measure of Grey Scale Synovial Hypertrophy will be calculated. The change in the scores will be analyzed between the two groups.
HAQ-DI	Baseline to 4 Weeks	Self-administered HAQ-DI summary score will be calculated. The change in the scores will be analyzed between the two groups

Trial Locations

Locations (1)

UCLA David Geffen School of Medicine, Division of Rheumatology; 🇺🇸 Los Angeles, California, United States