RHYTHM (Formerly Escape II Myocardium)

• Status: Completed
• Trial end date: 2019-09-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

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

Criteria

For RA patients (150 patients):

INCLUSION CRITERIA

• Diagnosis of Rheumatoid Arthritis by 2010 American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) diagnostic criteria

• Age>18 years old

• Moderate to high RA disease activity defined by a Clinical Disease Activity Index (CDAI) of >10

• Stable dose of Methotrexate for 6 weeks prior to enrollment

• Stable doses of Nonsteroidal anti-inflammatory drug (NSAID) and prednisone (if already taking these medications) for 2 weeks prior to study

EXCLUSION CRITERIA

• Prior self reported or physician diagnosed CV event (MI; angina; stroke or Transient Ischemic Attach (TIA); Heart Failure (HF); prior CV procedure (e.g., coronary artery bypass graft, angioplasty, valve replacement, pacemaker)

• Contraindications to having a PET-CT scan or receive adenosine or Fludeoxyglucose (FDG)

• Active treatment for Cancer

• Uncontrolled hypertension

• Diabetes

• Smoking

• Treatment with a TNF inhibitor or other biologic currently or within the last 6 months

• Current treatment with "Triple Therapy" or within the last 2 months

• Untreated positive purified protein derivative (PPD) tuberculosis skin test or active tuberculosis

• History of Lymphoma and Melanoma

• Ejection Fraction (EF) < 40% (if not known in advance then the Study Visit I Echocardiogram results will be used to exclude the patient from randomization and follow up)

• Change in NSAID/Prednisone dosage in last 2 weeks

• Participation in other research studies involving imaging/radiation exposure

For non-RA subjects (25 controls):

INCLUSION CRITERIA

• Age>18 years old

• Absence of diagnosis of RA

EXCLUSION CRITERIA

• Prior self reported or physician diagnosed CV event (MI; angina; stroke or Transient Ischemic Attach (TIA); Heart Failure (HF); prior CV procedure (e.g., coronary artery bypass graft, angioplasty, valve replacement, pacemaker)

• Contraindications to having a PET-CT scan or receive adenosine or FDG

• Uncontrolled hypertension

• Participation in other research studies involving imaging/radiation exposure