NCT03511625

The Effects of Acthar on Synovial Inflammation in Rheumatoid Arthritis

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: Attune Health Research, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	Acthar Injectable Product	Acthar is a non-specific melanocortin receptor agonist
DRUG	Depo medrol	Depo medrol is an anti-inflammatory glucocorticoid

Timeline

• Start date: 2018-10-02
• Primary completion: 2020-02-26
• Completion: 2024-12-03
• First posted: 2018-04-30
• Last updated: 2024-01-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study