The Effects of Acthar on Synovial Inflammation in Rheumatoid Arthritis

Attune Health Research

Status and phase: Active, not recruiting; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Drug: Acthar Injectable Product; Drug: Depo medrol

Study type: Interventional

Funder types: Industry

Identifiers

NCT03511625

32971

Details and patient eligibility

About

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.

Enrollment: 6 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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6 participants in 2 patient groups

Acthar

Experimental group

Description:

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

Treatment:

Drug: Acthar Injectable Product

Depo Medrol

Active Comparator group

Description:

40 milligrams of Depo Medrol will be injected intramuscularly one time

Treatment:

Drug: Depo medrol