Use of Acthar in Rheumatoid Arthritis (RA) Related Flares



Status:Recruiting
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - Any
Updated:10/28/2017
Start Date:July 20, 2017
End Date:December 2019
Contact:Veena K Rangantah, M.D., M.S.
Email:vranganath@mednet.ucla.edu
Phone:310-825-3061

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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.

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.

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)
We found this trial at
1
site
Los Angeles, California 90095
Principal Investigator: Veena K Ranganath, M.D.
Phone: 310-825-6301
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from
Los Angeles, CA
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