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NCT03142321 · ClinicalTrials.gov registry record · Phase 4
Defining Predictors of RT Response to Vedolizumab in IBD
A Phase 4 study of Crohn Disease of Small Intestine, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 4
- Development phase
- 48
- Enrollment target
- 1
- Study location
NCT03142321 is a Phase 4 study of Crohn Disease of Small Intestine that has completed, run by Washington University School of Medicine. The registered enrollment target is 48 participants. The trial reports 1 study location across 1 state.
The verdict
NCT03142321, a Phase 4 study of Crohn Disease of Small Intestine, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 48 participants
- Enrollment target
- 1
- Study location
Study Summary
The overall goal of the study is to develop data that can convincingly guide clinicians on the use and efficacy of vedolizumab in patients with small bowel CD. There is an unmet need to identify response to vedolizumab in small bowel CD using objective endpoints. Current data suggest that MR enterography may meet this unmet need. There is an additional unmet need to develop predictive models incorporating both clinical and baseline radiological and endoscopic variables with higher discriminatory performance in identifying longer term clinical remission with vedolizumab. Finally, this proposal is strengthened by the exploratory studies which may identify new proteomic biomarkers that correlate with longer term radiological response with vedolizumab reflecting its latency of response. If successful, these serum biomarkers may guide a personalized approach to the treatment of small bowel CD with vedolizumab, allowing early identification of PNR, monitoring disease activity and the pharmacodynamics of vedolizumab.
Conditions Studied
Interventions
- DRUG Vedolizumab 300 MG Injection [Entyvio]
Study Locations (1)
Missouri
- Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2018-06-08 |
| Est. Completion | 2024-10-28 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03142321
The ClinicalTrials.gov registry entry for NCT03142321 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Crohn Disease of Small Intestine appearing as the primary indexed condition, and to 1 intervention - of which Vedolizumab 300 MG Injection [Entyvio] is the first listed.
NCT03142321 reports 1 study location spanning 1 distinct geographic area - top geographies include Missouri.
Frequently Asked Questions
What is clinical trial NCT03142321 about?
NCT03142321 is a clinical study titled "Defining Predictors of RT Response to Vedolizumab in IBD". The overall goal of the study is to develop data that can convincingly guide clinicians on the use and efficacy of vedolizumab in patients with small bowel CD. There is an unmet need to identify response to vedolizumab in small bowel CD using objective endpoints. Current data suggest that MR enterog...
What is the current status of trial NCT03142321?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 48 participants. The study started on 2018-06-08. Estimated completion is 2024-10-28.
What conditions does trial NCT03142321 study?
This clinical trial studies the following conditions: Crohn Disease of Small Intestine.
What interventions are being tested in trial NCT03142321?
The interventions under investigation include: Vedolizumab 300 MG Injection [Entyvio] (DRUG).
Who is sponsoring clinical trial NCT03142321?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03142321 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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