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NCT02425111 · ClinicalTrials.gov registry record · Phase 3
Effect of Intravenous (IV) Vedolizumab on Mucosal Healing in Crohn's Disease
A Phase 3 study of Crohn's Disease, sponsored by Takeda.
- Completed
- Registry status
- Phase 3
- Development phase
- 101
- Enrollment target
- 20
- Study locations
NCT02425111: Completed Phase 3 study of Crohn's Disease, sponsored by Takeda.
NCT02425111 is a Phase 3 study of Crohn's Disease that has completed, run by Takeda. The registered enrollment target is 101 participants, below the 2,394-participant average among 105 other Crohn's Disease trials with a reported enrollment target (96% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02425111, a Phase 3 study of Crohn's Disease, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 101 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate endoscopic remission at Week 26 as assessed by ileocolonoscopy.
Primary Outcome
Endoscopic remission is defined as a simple endoscopic score for Crohn's Disease (SES-CD) score of ≤4. The SES-CD evaluates 4 endoscopic variables (ulcer size, proportion of the surface area that is ulcerated, proportion of the surface area affected, and stenosis in 5 segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The score for each endoscopic variable is the sum of values obtained for each segment. The SES-CD total is the sum of the 4 e
Conditions Studied
Interventions
- DRUG Vedolizumab
Study Locations (20)
Florida
- - Gainesville
- - Inverness
- - Maitland
- - Miami
- - Winter Park
Georgia
- - Macon
- - Suwanee
New York
- - Manhasset
- - Poughkeepsie
California
- - La Jolla
Connecticut
- - Hamden
Kansas
- - Topeka
Louisiana
- - Baton Rouge
Maryland
- - Columbia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 101 participants |
| Start Date | 2015-03-30 |
| Est. Completion | 2018-02-21 |
| Phase | Phase 3 |
What the finished NCT02425111 record still lists
NCT02425111 is an interventional study that assigns participants to a tested intervention. The registered 101 participants enrollment target is mid-sized for trials with a published cap, below the 2,394-participant average among 105 other Crohn's Disease trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Crohn's Disease appearing as the primary indexed condition, and to 1 intervention - of which Vedolizumab is the first listed.
NCT02425111 names 20 study sites across 14 states, led by Florida, Georgia, New York.
Frequently Asked Questions
What is clinical trial NCT02425111 about?
NCT02425111 is a clinical study titled "Effect of Intravenous (IV) Vedolizumab on Mucosal Healing in Crohn's Disease". The purpose of this study is to evaluate endoscopic remission at Week 26 as assessed by ileocolonoscopy.
What is the current status of trial NCT02425111?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 101 participants. The study started on 2015-03-30. Estimated completion is 2018-02-21.
What conditions does trial NCT02425111 study?
This clinical trial studies the following conditions: Crohn's Disease.
What interventions are being tested in trial NCT02425111?
The interventions under investigation include: Vedolizumab (DRUG).
Who is sponsoring clinical trial NCT02425111?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02425111 being conducted?
This trial has 20 study locations across California, Connecticut, Florida, Georgia, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Crohn's Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02425111's enrollment target sits among peer trials
101 69th of 105 higher than 37 of 105 other Crohn's Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Crohn's Disease 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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