Rheumatoid Arthritis Clinical Trial
— RHYTHMOfficial title:
RHYTHM (RHeumatoid Arthritis studY of THe Myocardium): How Rheumatoid Arthritis (RA) and Tumor Necrosis Factor (TNF) Inhibitors Affect the Myocardial Structure and Function.
Verified date | November 2020 |
Source | Columbia University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 149 |
Est. completion date | September 2019 |
Est. primary completion date | September 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Columbia University Medical Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Columbia University | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
United States,
Amigues I, Tugcu A, Russo C, Giles JT, Morgenstein R, Zartoshti A, Schulze C, Flores R, Bokhari S, Bathon JM. Myocardial Inflammation, Measured Using 18-Fluorodeoxyglucose Positron Emission Tomography With Computed Tomography, Is Associated With Disease A — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Myocardial FDG Uptake | This is designed to evaluate the baseline characteristics of the cross sectional RA cohort to understand the correlation of disease activity measured by the Clinical Disease Activity Index (CDAI) with myocardial inflammation measured by fluorodeoxyglucose (FDG) uptake in positron emission tomography (PET) scan at the baseline visit. Myocardial FDG uptake is classified as "diffuse" or "focal." | Baseline | |
Secondary | Number of Participants With Myocardial FDG Uptake After Escalation of RA Pharmacotherapy | This is designed to measure the myocardial inflammation, and its association with change in CDAI, after ramp-up of RA therapy over 6 months. Measurements are taken at baseline and 6-months post treatment escalation. Myocardial FDG uptake is classified as "diffuse" or "focal." | Baseline, 6-Month Follow-up | |
Secondary | LV Structure (Mean EDVI) in Association With Myocardial FDG Uptake | This is designed to evaluate the baseline characteristics of the entire RA cohort to understand the association of myocardial inflammation measure by FDG uptake with measures of left ventricular (LV) structure measured by 2D/3D echocardiogram at the baseline visit. | Baseline | |
Secondary | LV Function (Mean Stroke Volume Index) in Association With Myocardial FDG Uptake | This is designed to evaluate the baseline characteristics of the entire RA cohort to understand the association of myocardial inflammation measure by FDG uptake with measures of left ventricular (LV) function measured by 2D/3D echocardiogram at the baseline visit. | Baseline |
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