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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 is a Phase 4 study that has completed, run by Columbia University. The registered enrollment target is 149 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01548768
The ClinicalTrials.gov registry entry for NCT01548768 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 149 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which TNF inhibitors is the first listed.
NCT01548768 reports 0 study locations.
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.
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