Use of Acthar in Rheumatoid Arthritis (RA) Related Flares

Rheumatoid Arthritis (RA) Clinical Trial

Official title:

Use of Acthar in Rheumatoid Arthritis Related Flares

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02541955
• Other study ID #: Acthar in Rheumatoid Arthritis
• Status: Recruiting
• Phase: Phase 4
• Start date: July 20, 2017
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: University of California, Los Angeles
• Contact: Veena K Rangantah, M.D., M.S.
• Phone: 310-825-3061
• Email: vranganath[@]mednet.ucla.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis (RA)

Intervention

Drug:
• Acthar
Injections will be self administered

Locations

Country	Name	City	State
United States	UCLA David Geffen School of Medicine, Division of Rheumatology	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Veena Ranganath, MD, MS

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ultrasound Power Doppler Score	Using Ultrasound a measure of Power Doppler will be calculated. The change in the scores will be analyzed between the two groups.	Baseline to 2 Weeks
Primary	DAS28	DAS28 will be calculated. The change in the scores will be analyzed between the two groups.	Baseline to 2 Weeks
Secondary	Ultrasound Grey Scale Synovial Hypertrophy score	Using Ultrasound a measure of Grey Scale Synovial Hypertrophy will be calculated. The change in the scores will be analyzed between the two groups.	Baseline to 2 Weeks
Secondary	HAQ-DI	Self-administered HAQ-DI summary score will be calculated. The change in the scores will be analyzed between the two groups	Baseline to 4 Weeks