RHYTHM (Formerly Escape II Myocardium) (RHYTHM)
Anti-TNF drugs are a major class of treatment in patients with rheumatoid arthritis (RA). Data in non-RA patients with advanced heart failure suggest that anti-TNF agents may not help heart failure and may even be harmful. However, the effect of these agents on the hearts of RA patients has never been directly studied. However, observational studies suggest that anti-TNF agents may actually prevent the onset of heart failure in RA patients and may reduce hospitalizations in RA patients who have heart failure. 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).
In order to investigate these hypotheses, the investigators will identify 25 patients who have joint inflammation that have not responded adequately to treatment with methotrexate or other oral DMARDs . As would happen under standard of care (even without participation in the study) patients will receive additional treatment to control their joint disease. The investigators will assign these patients to be prescribed (in agreement with the patients and their Rheumatologists), a TNF inhibitor in addition to their current treatment.TNF inhibitors are an FDA approved treatment for management of RA and have been used by Rheumatologists for many years. At enrollment and 6 months after starting treatment patients will have imaging of their heart with PET-CT scanning and echocardiogram at both time points. Participants will also provide information about their RA and other medical conditions and blood will be drawn.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||RHYTHM (RHeumatoid Arthritis studY of THe Myocardium): How Rheumatoid Arthritis (RA) and Tumor Necrosis Factor (TNF) Inhibitors Affect the Myocardial Structure and Function.|
- Change in left ventricular mass [ Time Frame: 6 months after treatment with TNF inhibitors versus triple therapy ] [ Designated as safety issue: No ]We will evaluate the differential effect TNF inhibitors vs "triple therapy" on LV mass after 6 months of treatment for improvement.
- Change in Left Ventricular Ejection Fraction [ Time Frame: After 6 months of treatment with TNF inhibitor versus triple therapy ] [ Designated as safety issue: No ]We will evaluate LVEF for improvement.
- Change in the degree of myocardial inflammation (as indicated by FDG uptake in PET scanning) [ Time Frame: 6 months after treatment with TNF inhibitor versus triple therapy ] [ Designated as safety issue: No ]
|Study Start Date:||October 2011|
|Estimated Study Completion Date:||October 2016|
|Estimated Primary Completion Date:||October 2016 (Final data collection date for primary outcome measure)|
Disease activity will be evaluated at the time of every visit.. At the time of the first safety visit, tolerability and safety will be evaluated. At the time of Safety Visit II if CDAI is still >10 (indicative of moderate disease activity) an increase in the dose or frequency of the TNF inhibitor (in the case of agents such as infliximab or adalimumab where escalation of dosage is an option) or a switch to treatment to an alternative TNF inhibitor will take place. Patients will return at 24 weeks for their Second Study Visit (Study Visit 2) for completion of the study and further management as per standard of care. An additional Safety Visit (Safety Visit 3) will take place at 32 weeks and will serve as an exit safety visit.
Drug: TNF inhibitors
Patients will receive one of the FDA approved TNF inhibitors at the approved dosage regimen.
Patients will be evaluated during safety visits scheduled every 8 weeks between the 0 and 6 month study visits. At the time of the ﬁrst safety visit medication tolerability and safety will be evaluated. At the time of the second safety visit if joint disease activity is still moderate or high an increase in the dose or frequency of the TNF inhibitor or a switch to treatment to an alternative/equivalent TNF inhibitor will take place ( there are 5 TNF inhibitors approved at the moment).
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01548768
|Contact: Janine Rose, BSemail@example.com|
|Contact: Afshin Zartoshti, MSfirstname.lastname@example.org|
|United States, New York|
|Columbia University Medical Center||Recruiting|
|New York, New York, United States, 10032|
|Contact: Janine Rose 212-305-4114 email@example.com|
|Contact: Afshin Zartoshti, MS 2123422751 firstname.lastname@example.org|
|Principal Investigator: Joan M Bathon, MD|
|Principal Investigator:||Joan M Bathon, MD||Columbia University|