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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.
Full description
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. At screening visit, inclusion and exclusion criteria will be assessed. If assessments have not been completed to verify these criteria, they will be performed at this visit. After patients are confirmed to meet criteria, patient disease activity will be assessed and blood draw, synovial aspiration, and biopsy will be performed before first treatment injection. About 5 days after this first treatment injection, these assessment and samples will be performed again. About 5-6 weeks after first treatment injection, a final physician assessment will be performed. Patients will have the option of consenting to allow storage of samples for future research.
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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:
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
Primary purpose
Allocation
Interventional model
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6 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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