Use of Acthar in Rheumatoid Arthritis (RA) Related Flares

Veena Ranganath, MD, MS

Status and phase: Enrolling; Phase 4

Conditions: Rheumatoid Arthritis (RA)

Treatments: Drug: Acthar

Study type: Interventional

Funder types: Other

Identifiers

NCT02541955

Acthar in Rheumatoid Arthritis

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

40 Units

Active Comparator group

Description:

40 units of Acthar per week

Treatment:

Drug: Acthar

80 Units

Active Comparator group

Description:

80 units of Acthar twice per week

Treatment:

Drug: Acthar