Use of Acthar in Rheumatoid Arthritis (RA) Related Flares

November 27, 2023 updated by: Veena Ranganath, MD, MS

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

Recruiting

Conditions

Intervention / 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 Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Recruiting
        • UCLA David Geffen School of Medicine, Division of Rheumatology
        • Principal Investigator:
          • Veena K Ranganath, M.D.
        • Contact:
        • Sub-Investigator:
          • Suzanne Kafaja, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Ultrasound Power Doppler Score
Time Frame: 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.
Baseline to 2 Weeks
DAS28
Time Frame: Baseline to 2 Weeks
DAS28 will be calculated. The change in the scores will be analyzed between the two groups.
Baseline to 2 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ultrasound Grey Scale Synovial Hypertrophy score
Time Frame: 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.
Baseline to 2 Weeks
HAQ-DI
Time Frame: 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
Baseline to 4 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Veena Ranganath, MD, MS

Investigators

  • Principal Investigator: Veena K Ranganath, M.D., M.S., University of California, Los Angeles

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 20, 2017

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

December 1, 2023

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)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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