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Methotrexate

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Patients 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.

Patients will receive their current treatment in an open label protocol in the context of standard of care.

Subjects without RA who will function as controls.

TNF inhibitors are an FDA approved class of medications indicated for the treatment of RA when initial treatment (usually with methotrexate) has failed to achieve remission of RA disease activity. TNF inhibitors are part of the standard of care management of RA.

The possible TNF inhibitors are: Remicade, Humira, Enbrel, Cimzia, Simponi.

TNF inhibitors

Standard of care treatment for RA, such as Methotrexate or other disease-modifying antirheumatic drugs.

DMARDs

Joan M Bathon, MD

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).

Patients with Rheumatoid Arthritis (RA) have a shortened life expectancy compared to the general population. Cardiovascular disease (CVD), including heart failure (HF), is the primary cause of the extra deaths in RA. HF, in general, results from failure of the heart muscle to pump adequately. In other words the heart muscle in HF becomes "weak". In patients without RA, the heart muscle gets larger before symptoms of HF appear. Contrary to that, patients with RA have reduced heart size and reduced heart strength. This may mean that in RA the pathway to heart failure may be different compared to what happens in patients without RA. It is possible - for example - that in RA the heart muscle becomes smaller before it becomes weak (while in non-RA patients the heart muscle becomes larger before it becomes weak). It is possible that cells that create inflammation in the joints may also do the same in the heart muscle making it smaller, thinner and eventually weaker.

Patients with RA nowadays can be treated with a variety of medications for their joint inflammation. These medications are powerful and have reduced the risk of permanent joint damage and disability. However it is unknown what is the effect of these medications on the heart size and strength and whether they increase or decrease the risk for cardiovascular disease and heart failure.

Among the medications used for RA are medications called TNF inhibitors. They are usually prescribed to patients who have joint inflammation that has not responded to treatment with the first line medication Methotrexate. 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. Some observational studies suggest that RA patients treated with TNF inhibitors have a lower risk of developing heart disease. Overall the knowledge regarding the effect of TNF inhibitors on RA patients heart function is limited.

RHYTHM (Formerly Escape II Myocardium)

RHYTHM (RHeumatoid Arthritis studY of THe Myocardium): How Rheumatoid Arthritis (RA) and Tumor Necrosis Factor (TNF) Inhibitors Affect the Myocardial Structure and Function.

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."

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."

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.

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.

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Columbia University

Professor Medicine, Rheumatology

An adverse event (AE) is any undesirable sign, symptom or medical condition occurring after starting study drug (or therapy). Medical conditions/diseases present before starting study treatment are only considered adverse events if they worsen after starting study therapy. In addition all adverse events regardless of whether they constitute unanticipated problems as well as AEs thought to be possibly related to study procedures will also be reported to IRB, safety officer, SMC, and NIH/NIAMS.

Participants were randomized to TNFi or DMARD therapy. Patients will receive their current treatment in an open label protocol in the context of standard of care.

TNFi: biologic treatment for RA, such as Humira, Enbrel, Remicade,

RA Patients - Pharmacotherapy Escalation (TNFi)

Participants were randomized to TNFi or DMARD therapy. Patients will receive their current treatment in an open label protocol in the context of standard of care.

DMARDs: Standard of care treatment for RA, such as Methotrexate or other disease-modifying antirheumatic drugs.

RA Patients - Pharmacotherapy Escalation (DMARD)

Healthy Volunteers

A cohort of patients with Rheumatoid Arthritis will undergo the baseline study visit only (no randomization to treatment). Note, that those who were randomized, their data will be utilized in the full cross sectional analysis.

Patients - Cross Sectional (RA)

Patients 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.

TNF inhibitors: TNF inhibitors are an FDA approved class of medications indicated for the treatment of RA when initial treatment (usually with methotrexate) has failed to achieve remission of RA disease activity. TNF inhibitors are part of the standard of care management of RA.

The possible TNF inhibitors are: Remicade, Humira, Enbrel, Cimzia, Simponi.

DMARDs: Standard of care treatment for RA, such as Methotrexate or other disease-modifying antirheumatic drugs.

Patients - DMARDs + TNF Inhibitors

Patients will receive their current treatment in an open label protocol in the context of standard of care.

DMARDs: Standard of care treatment for RA, such as Methotrexate or other disease-modifying antirheumatic drugs.

Patients - DMARDs Only

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

RA participants=133, Healthy Volunteers=16

Dr. Joan Bathon, MD

Diffuse FDG Uptake

Focal FDG Uptake

No FDG Uptake

A cohort of patients with Rheumatoid Arthritis who underwent the baseline visit analysis and completed the visit in the full cross sectional analysis.

A cohort of healthy volunteers (those without an autoimmune or history of cardiac illness) was utilized. n=16 were recruited directly, while n=11 were recruited via the CUIMC Nuclear Cardiology archive.

2 RA patients and 1 healthy volunteer (control subject) were not included in this analysis population because the subjects withdrew study participation prior to scan (no data were collected).

Number of Participants With Myocardial FDG Uptake

Focal Baseline FDG Uptake

Focal Follow-up FDG Uptake

Diffuse Baseline FDG Uptake

Diffuse Follow-up FDG Uptake

Participants were randomized to TNFi or DMARD therapy.

Patients will receive their current treatment in an open label protocol in the context of standard of care.

TNFi: biologic treatment for RA, such as Humira, Enbrel, Remicade,

Participants were randomized to TNFi or DMARD therapy.

Patients will receive their current treatment in an open label protocol in the context of standard of care.

DMARDs: Standard of care treatment for RA, such as Methotrexate or other disease-modifying antirheumatic drugs.

2 TNFi, and 2 DMARDs and 1 healthy volunteer (control subject) were not included in this analysis population because the subjects withdrew participation prior to study completion or scan (no data were collected).

Number of Participants With Myocardial FDG Uptake After Escalation of RA Pharmacotherapy

A cohort of healthy volunteers (those without an autoimmune or history of cardiac illness) was utilized. n=16 were recruited directly, while n=11 were recruited via the CUIMC Nuclear Cardiology archive

Only 119 out of 121 subjects had data analyzed due to 2 subject withdrawals prior to scan.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
RHYTHM (Formerly Escape II Myocardium)	NCT01548768	Rheumatoid Arth...	TNF inhibitors DMARDs	18 Years -	Columbia University
RHYTHM (Formerly Escape II Myocardium)	NCT01548768	Rheumatoid Arth...	TNF inhibitors DMARDs	18 Years -	Columbia University

Spots Global Cancer Trial Database for myocardium

Every month we try and update this database with for myocardium cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for myocardium

Every month we try and update this database with for myocardium cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for myocardium cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.