Trial | NCT03511625  Report issue

Title

The Effects of Acthar on Synovial Inflammation in Rheumatoid Arthritis
The Effects of Acthar on Synovial Inflammation in Rheumatoid Arthritis: A Pilot Study

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Active, not recruiting

  • Study Participants

    6
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.
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.
Study Started
Oct 02
2018
Primary Completion
Feb 26
2020
Study Completion
Dec 01
2023
Anticipated
Last Update
Feb 15
2023

Drug Acthar Injectable Product

Acthar is a non-specific melanocortin receptor agonist

  • Other names: repository corticotropin injection, H.P. Acthar Gel

Drug Depo medrol

Depo medrol is an anti-inflammatory glucocorticoid

  • Other names: methylprednisolone acetate injectable suspension

Acthar Experimental

80 units of Acthar Injectable Product will be injected subcutaneously daily for three days, followed by twice weekly for four weeks.

Depo Medrol Active Comparator

40 milligrams of Depo Medrol will be injected intramuscularly one time

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:

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.

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
No Results Posted