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NCT02324699 · ClinicalTrials.gov registry record · Phase 4

Corticosteroids With Vedolizumab in Crohn's Disease

A Phase 4 study, sponsored by Icahn School of Medicine at Mount Sinai.

Terminated
Registry status
Phase 4
Development phase
1
Enrollment target

NCT02324699: Clinical Trial Phase 4 study, sponsored by Icahn School of Medicine at Mount Sinai.

NCT02324699 is a Phase 4 study that was terminated before completion, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 1 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02324699, a Phase 4 study, was terminated before completion, sponsored by Icahn School of Medicine at Mount Sinai.

TERMINATED
Registry status
Phase 4
Development phase
1 participants
Enrollment target

Study Summary

Use of co-induction with corticosteroid therapies may accelerate the remission rate when used with vedolizumab. Further, this may lead to higher rates of response and remission at week 10 than would be seen with vedolizumab monotherapy.

Primary Outcome

Clinical remission, defined as CDAI \< 150, in group with steroid co-induction vs. placebo co-induction. The purpose of this crohn's disease activity index (CDAI) calculator is to gauge the progress or lack of progress for people with crohn's disease. CDAI scores below 150 indicate a better prognosis than higher scores

Interventions

  • DRUG Placebo
  • DRUG Prednisone
  • DRUG Vedolizumab

Trial Details

FieldValue
Enrollment Target 1 participants
Start Date 2016-04
Est. Completion 2018-02-08
Phase Phase 4

Why NCT02324699 stopped before completion

NCT02324699 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (100% lower).

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT02324699 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02324699 about?

NCT02324699 is a clinical study titled "Corticosteroids With Vedolizumab in Crohn's Disease". Use of co-induction with corticosteroid therapies may accelerate the remission rate when used with vedolizumab. Further, this may lead to higher rates of response and remission at week 10 than would be seen with vedolizumab monotherapy.

What is the current status of trial NCT02324699?

This trial is currently terminated. It is a Phase 4 study. The enrollment target is 1 participants. The study started on 2016-04. Estimated completion is 2018-02-08.

What interventions are being tested in trial NCT02324699?

The interventions under investigation include: Placebo (DRUG), Prednisone (DRUG), Vedolizumab (DRUG).

Who is sponsoring clinical trial NCT02324699?

This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02324699's enrollment target sits among peer trials

1 2000th of 2000 the lowest 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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Source: ClinicalTrials.gov NCT02324699, the US trial registry maintained by the National Library of Medicine. NCT02324699 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.