Use of Acthar in Rheumatoid Arthritis (RA) Related Flares

Study Overview
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Brief Summary
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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
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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.

Official Title
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Use of Acthar in Rheumatoid Arthritis Related Flares

Conditions
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Rheumatoid Arthritis (RA)

Intervention / Treatment
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* Drug: Acthar


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient must meet 1987 ACR criteria Age > 18 years of age Baseline DAS28/Erythrocyte Sedimentation Rate (ESR) >=3.2 Stable concomitant Disease Modifying Anti-Rheumatic Drugs (DMARDs) Stable prednisone <10mg or equivalent Power Doppler score of >=10 Exclusion Criteria: Prior treatment with Acthar in the past 2mos Meet one of the above RA flare requirements Subjects who have received live or live attenuated vaccines within 6 weeks prior to the first dose of study drug (or the zoster vaccine)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 40 Units<br>40 units of Acthar per week | Drug: Acthar<br>* Injections will be self administered<br>* Other names: Repository corticotropin injection;|
| Active Comparator: 80 Units<br>80 units of Acthar twice per week | Drug: Acthar<br>* Injections will be self administered<br>* Other names: Repository corticotropin injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| DAS28 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rheumatoid arthritis (RA), Musculoskeletal ultrasound (MSUS)