The Effects of Acthar on Synovial Inflammation in Rheumatoid Arthritis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-02

Study Completion Date

2024-12-03

Brief Summary

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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.

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Detailed Description

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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. 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.

Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Acthar

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

Group Type EXPERIMENTAL

Acthar Injectable Product

Intervention Type DRUG

Acthar is a non-specific melanocortin receptor agonist

Depo Medrol

40 milligrams of Depo Medrol will be injected intramuscularly one time

Group Type ACTIVE_COMPARATOR

Depo medrol

Intervention Type DRUG

Depo medrol is an anti-inflammatory glucocorticoid

Interventions

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Acthar Injectable Product

Acthar is a non-specific melanocortin receptor agonist

Intervention Type DRUG

Depo medrol

Depo medrol is an anti-inflammatory glucocorticoid

Intervention Type DRUG

Other Intervention Names

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repository corticotropin injection H.P. Acthar Gel methylprednisolone acetate injectable suspension

Eligibility Criteria

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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:

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No