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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: Completed Phase 4 study of Crohn Disease of Small Intestine, sponsored by Washington University School of Medicine.
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, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Radiological Transmural Response will be defined per-lesion and per-patient. Per-lesion TR will be defined as a decrease in the length of inflamed small bowel lesion from baseline or improvement in any imaging findings associated with severe mural inflammation, i.e., restricted diffusion, mural thickness, intramural T2 hyperintensity, peri-enteric T2 signal, and luminal ulcerations, without development of a new penetrating or stricturing complication. Worsened lesions will be fined as those with
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 |
What the finished NCT03142321 record still lists
NCT03142321 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (91% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03142321's enrollment target sits among peer trials
48 1331st of 2000 higher than 654 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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