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NCT04629196 · ClinicalTrials.gov registry record · Phase 4
Induction Optimization With Stelara for Crohn's Disease
A Phase 4 study, sponsored by NYU Langone Health.
- Terminated
- Registry status
- Phase 4
- Development phase
- 12
- Enrollment target
NCT04629196: Clinical Trial Phase 4 study, sponsored by NYU Langone Health.
NCT04629196 is a Phase 4 study that was terminated before completion, run by NYU Langone Health. The registered enrollment target is 12 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04629196, a Phase 4 study, was terminated before completion, sponsored by NYU Langone Health.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 12 participants
- Enrollment target
Study Summary
This is a 16-week randomized controlled trial comparing a second IV weight-based induction dose at week 8 to standard 90mg subcutaneous dose at week 8, with a primary endpoint of clinical remission at week 16.
Primary Outcome
The Crohn's Disease Activity Index or CDAI is frequently used to assess disease severity. It gives a score ranging from 0 to over 600, based on a diary of symptoms kept by the patient for 7 days, and other measurements such as the patient's weight and haematocrit. A CDAI score of less than 150 is considered to be clinical remission.
Interventions
- DRUG Ustekinumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2022-02-16 |
| Est. Completion | 2024-01-17 |
| Phase | Phase 4 |
Why NCT04629196 stopped before completion
NCT04629196 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Ustekinumab is the first listed.
NCT04629196 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04629196 about?
NCT04629196 is a clinical study titled "Induction Optimization With Stelara for Crohn's Disease". This is a 16-week randomized controlled trial comparing a second IV weight-based induction dose at week 8 to standard 90mg subcutaneous dose at week 8, with a primary endpoint of clinical remission at week 16.
What is the current status of trial NCT04629196?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 12 participants. The study started on 2022-02-16. Estimated completion is 2024-01-17.
What interventions are being tested in trial NCT04629196?
The interventions under investigation include: Ustekinumab (DRUG).
Who is sponsoring clinical trial NCT04629196?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04629196's enrollment target sits among peer trials
12 1913th of 2000 higher than 70 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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