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NCT01224171 · ClinicalTrials.gov registry record · Phase 3
Study of Vedolizumab in Patients With Moderate to Severe Crohn's Disease
A Phase 3 study, sponsored by Millennium Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 416
- Enrollment target
NCT01224171: Completed Phase 3 study, sponsored by Millennium Pharmaceuticals.
NCT01224171 is a Phase 3 study that has completed, run by Millennium Pharmaceuticals. The registered enrollment target is 416 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (46% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01224171, a Phase 3 study, has completed, sponsored by Millennium Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 416 participants
- Enrollment target
Study Summary
This study in patients with moderately to severely active Crohn's disease is designed to establish the efficacy and safety of vedolizumab for the induction of clinical response and remission.
Primary Outcome
Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score ≤ 150 points. The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are: * Number of liquid or soft stools each day for 7 days; * Abdominal pain (graded from 0-3 on severity) each day for 7 days; * General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 d
Interventions
- OTHER Placebo
- DRUG vedolizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 416 participants |
| Start Date | 2010-11 |
| Est. Completion | 2012-04 |
| Phase | Phase 3 |
What the finished NCT01224171 record still lists
NCT01224171 is an interventional study that assigns participants to a tested intervention. The registered 416 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (46% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01224171 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01224171 about?
NCT01224171 is a clinical study titled "Study of Vedolizumab in Patients With Moderate to Severe Crohn's Disease". This study in patients with moderately to severely active Crohn's disease is designed to establish the efficacy and safety of vedolizumab for the induction of clinical response and remission.
What is the current status of trial NCT01224171?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 416 participants. The study started on 2010-11. Estimated completion is 2012-04.
What interventions are being tested in trial NCT01224171?
The interventions under investigation include: Placebo (OTHER), vedolizumab (DRUG).
Who is sponsoring clinical trial NCT01224171?
This trial is sponsored by Millennium Pharmaceuticals, which has 135 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01224171's enrollment target sits among peer trials
416 902nd of 2000 higher than 1,098 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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