Phase 4
N=149
RHYTHM (Formerly Escape II Myocardium)
Rheumatoid Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT01548768 ↗Enrolled (actual)
149
Serious AEs
0.7%
Results posted
Nov 2020
Primary outcome: Primary: Number of Participants With Myocardial FDG Uptake — 21; 4; 25; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- TNF inhibitors (Drug); DMARDs (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Columbia University
- Primary completion
- Sep 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Myocardial FDG Uptake |
21; 4; 25; 1; 73; 10 | — |
| SECONDARY Number of Participants With Myocardial FDG Uptake After Escalation of RA Pharmacotherapy |
1; 1; 1; 1; 0; NA | — |
| SECONDARY LV Structure (Mean EDVI) in Association With Myocardial FDG Uptake |
53.8; 49.1 | — |
| SECONDARY LV Function (Mean Stroke Volume Index) in Association With Myocardial FDG Uptake |
58.6; 31.3 | — |
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).
Eligibility 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) 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
Data sourced from ClinicalTrials.gov (NCT01548768). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.