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NCT02403323 · ClinicalTrials.gov registry record · Phase 3
Open-Label Extension and Safety Study for Participants With Crohn's Disease Previously Enrolled in the Etrolizumab Phase III Study GA29144
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Terminated
- Registry status
- Phase 3
- Development phase
- 790
- Enrollment target
NCT02403323: Clinical Trial Phase 3 study, sponsored by Hoffmann-La Roche.
NCT02403323 is a Phase 3 study that was terminated before completion, run by Hoffmann-La Roche. The registered enrollment target is 790 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02403323, a Phase 3 study, was terminated before completion, sponsored by Hoffmann-La Roche.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 790 participants
- Enrollment target
Study Summary
This open-label extension and safety monitoring study is composed of two parts: Part 1 will evaluate the long-term safety and efficacy of continued etrolizumab treatment in participants with moderately to severely active Crohn's disease who were previously enrolled in the etrolizumab Phase III Study GA29144 (NCT02394028) and who meet eligibility criteria for enrollment into Part 1. In Part 2, participants who have stopped etrolizumab treatment (either by exiting Part 1 of this study or by entering directly from Study GA29144 \[NCT02394028\]) will be monitored for 92 weeks for progressive multifocal leukoencephalopathy (PML) and other safety events.
Primary Outcome
CDAI is a score obtained from composite of eight assessments: number of liquid or soft stools, abdominal pain, general well-being, presence of complications, taking lomotil (diphenoxylate/atropine) or other opiates for diarrhea, presence of an abdominal mass, hematocrit, and percentage deviation from standard weight. A decrease in CDAI over time indicates improvement in disease activity. CDAI scores range from 0 to 600. A higher score indicates worse outcome. A total score of less than 150 corre
Interventions
- DRUG Etrolizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 790 participants |
| Start Date | 2015-06-08 |
| Est. Completion | 2023-10-09 |
| Phase | Phase 3 |
Why NCT02403323 stopped before completion
NCT02403323 is an interventional study that assigns participants to a tested intervention. The registered 790 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which Etrolizumab is the first listed.
NCT02403323 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02403323 about?
NCT02403323 is a clinical study titled "Open-Label Extension and Safety Study for Participants With Crohn's Disease Previously Enrolled in the Etrolizumab Phase III Study GA29144". This open-label extension and safety monitoring study is composed of two parts: Part 1 will evaluate the long-term safety and efficacy of continued etrolizumab treatment in participants with moderately to severely active Crohn's disease who were previously enrolled in the etrolizumab Phase III Study...
What is the current status of trial NCT02403323?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 790 participants. The study started on 2015-06-08. Estimated completion is 2023-10-09.
What interventions are being tested in trial NCT02403323?
The interventions under investigation include: Etrolizumab (DRUG).
Who is sponsoring clinical trial NCT02403323?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02403323's enrollment target sits among peer trials
790 429th of 2000 higher than 1,570 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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