The Effects of Acthar on Synovial Inflammation in Rheumatoid Arthritis

Status unconfirmed · Phase 3

Conditions studied: Rheumatoid Arthritis

In brief

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.

Key facts

Study ID

NCT03511625

Run by

Attune Health Research, Inc.

People needed

6

Starts

2018-10-02

Expected to finish

2024-12-03

Last updated by the study team

2024-01-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• Joint must be tender
• Joint must be swollen
• Joint must have +2 or +3 doppler signal by ultrasound exam
• 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.

You may not qualify if…

• 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

Where it is running

• Attune Health — Beverly Hills, California, United States

Full record on ClinicalTrials.gov

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