The Effects of Acthar on Synovial Inflammation in Rheumatoid Arthritis

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Patients will be assigned to receive either Depo Medrol or Acthar treatment. A synovial biopsy, blood draws, synovial fluid aspiration, and physician assessments will be performed before and after initiating treatment.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Attune Health Research, Inc.
• Collaborator: Mallinckrodt
• Treatments: Adrenocorticotropic Hormone; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria:

• Anti-Cyclic Citrullinated Peptide positive rheumatoid arthritis

• on a stable regimen of medications

• moderate to severe disease activity as measured by the Clinical Disease activity index (CDAI), or DAS28 (Disease Activity Score) within 30 days of starting the study

• Patients must have at least one joint with the following features within 30 days of starting the study:

1. Joint must be tender

2. Joint must be swollen

3. Joint must have +2 or +3 doppler signal by ultrasound exam

4. Joint must have +2 or +3 gray scale synovitis by ultrasound exam e. Joint must be amenable to synovial biopsy.

f. Clinician assessing the joint must conclude, with a reasonable degree of certainty, that the swelling and tenderness observed in the joint is caused by rheumatoid arthritis, and not by another arthritic condition such as osteoarthritis, crystal arthritis, or infection.

Exclusion Criteria:

• Patients on anti-coagulation therapy

• Patients with an active infection

• Patients receiving oral corticosteroids within 5 days of enrollment, or parenteral corticosteroids within 3 weeks of enrollment (unless deemed able to taper off medication under investigator oversight and supervision)

• Patients with any history of joint infection

• Patients with a history of tuberculosis or coccidioidomycosis