Overview

RHYTHM (Formerly Escape II Myocardium)

Status:
Completed
Trial end date:
2019-09-01
Target enrollment:
Participant gender:
Summary
For aim 1, the proposed studies will be performed in 150 patients with RA and 25 subjects without RA (healthy volunteers) who will function as controls. For aim 2, 25 of the patients enrolled in aim 1 (who are in need for further treatment due to increased RA activity despite their current treatment) will be recruited to continue in the study for an additional 24 (+/- 2) weeks (or 6 months). These patient will receive a TNF inhibitor in addition to their current treatment in an open label protocol for increased disease activity and in the context of standard of care. The investigators hypothesize that anti-TNF agents in RA patients without heart disease will not adversely affect the heart (will not cause a detrimental change in heart structure or its function).
Phase:
Phase 4
Details
Lead Sponsor:
Columbia University
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Treatments:
Adalimumab
Antirheumatic Agents
Certolizumab Pegol
Infliximab
Tumor Necrosis Factor Inhibitors