Clinical trial · Interventional
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rheumatoid Arthritis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DMARDs | Drug | — | UNRESOLVED |
| TNF inhibitors | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Patients - DMARDs + TNF Inhibitors
- description
- 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.
- interventionNames
- Drug: TNF inhibitors
- Drug: DMARDs
- type
- ACTIVE_COMPARATOR
- label
- Patients - DMARDs only
- description
- Patients will receive their current treatment in an open label protocol in the context of standard of care.
- interventionNames
- Drug: DMARDs
- type
- NO_INTERVENTION
- label
- Healthy Volunteers
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTAmigues 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 Activity in Rheumatoid Arthritis. Arthritis Rheumatol. 2019 Apr;71(4):496-506. doi: 10.1002/art.40771. Epub 2019 Feb 28. PMID 30407745