Repository Corticotropin Injection To Treat Rheumatoid Arthritis Patients Who Have Failed Three Biologic Therapies.

• Status: Completed
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

Summary

It is hypothesized that repository corticotropin injection in combination with other biologic agents will be able to provide relief of both rheumatoid arthritis and acute exacerbations of rheumatoid arthritis for patients with disease that had inadequately responded to biologics previously.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Arthritis Treatment Center, Maryland
• Treatments: Adrenocorticotropic Hormone

Criteria

Inclusion Criteria:

• Rheumatoid arthritis of at least 2 years duration

• On at least third biologic with a different mechanism of action for at least 12 weeks

• Active disease as defined by at least 6 tender and 6 swollen joints

• Erythrocyte sedimentation rate (ESR) at least 28 mm/hr or C-reactive protein (CRP) at least 1.2 times the upper limit of normal

• Stable dose of disease modifying anti-rheumatic drug (DMARD) and prednisone for at least 4 weeks

Exclusion Criteria:

• Prior treatment with Acthar Gel

• History of intolerance or allergy to glucocorticoids

• Unstable diabetes

• Active infection