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NCT01548768 · ClinicalTrials.gov registry record · Phase 4
RHYTHM (Formerly Escape II Myocardium)
A Phase 4 study, sponsored by Columbia University.
- Completed
- Registry status
- Phase 4
- Development phase
- 149
- Enrollment target
NCT01548768: Completed Phase 4 study, sponsored by Columbia University.
NCT01548768 is a Phase 4 study that has completed, run by Columbia University. The registered enrollment target is 149 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01548768, a Phase 4 study, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 149 participants
- Enrollment target
Study 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).
Primary Outcome
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."
Interventions
- DRUG TNF inhibitors
- DRUG DMARDs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 149 participants |
| Start Date | 2011-10-10 |
| Est. Completion | 2019-09 |
| Phase | Phase 4 |
What the finished NCT01548768 record still lists
NCT01548768 is an interventional study that assigns participants to a tested intervention. The registered 149 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (71% lower).
The record links to 0 conditions, and to 2 interventions - of which TNF inhibitors is the first listed.
NCT01548768 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01548768 about?
NCT01548768 is a clinical study titled "RHYTHM (Formerly Escape II Myocardium)". 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 treatmen...
What is the current status of trial NCT01548768?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 149 participants. The study started on 2011-10-10. Estimated completion is 2019-09.
What interventions are being tested in trial NCT01548768?
The interventions under investigation include: TNF inhibitors (DRUG), DMARDs (DRUG).
Who is sponsoring clinical trial NCT01548768?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01548768's enrollment target sits among peer trials
149 565th of 2000 higher than 1,434 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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