Use of Acthar in Rheumatoid Arthritis (RA) Related Flares

• Sponsor: Veena Ranganath, MD, MS (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT02541955
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 64.4
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis (RA)	Drug: Acthar	Phase 4

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Use of Acthar in Rheumatoid Arthritis Related Flares
• Actual Study Start Date: Jul 20, 2017
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 40 Units 40 units of Acthar per week	Drug: Acthar; Injections will be self administered
Active Comparator: 80 Units 80 units of Acthar twice per week	Drug: Acthar; Injections will be self administered

Outcome Measures

Primary Outcome Measures

1. 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.

2. DAS28 [Baseline to 2 Weeks]

   DAS28 will be calculated. The change in the scores will be analyzed between the two groups.

Secondary Outcome Measures

1. 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.

2. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCLA David Geffen School of Medicine, Division of Rheumatology	Los Angeles	California	United States	90095

Sponsors and Collaborators

• Veena Ranganath, MD, MS

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Veena Ranganath, MD, MS, Assistant Clinical Professor, University of California, Los Angeles
• ClinicalTrials.gov Identifier: NCT02541955
• Other Study ID Numbers: Acthar in Rheumatoid Arthritis
• First Posted: Sep 4, 2015
• Last Update Posted: Sep 29, 2021
• Last Verified: Sep 1, 2021

• 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
• Keywords provided by Veena Ranganath, MD, MS, Assistant Clinical Professor, University of California, Los Angeles: Rheumatoid arthritis (RA); Musculoskeletal ultrasound (MSUS)
• Additional relevant MeSH terms: Arthritis; Arthritis, Rheumatoid

Study Results

No Results Posted as of Sep 29, 2021