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NCT02118584 · ClinicalTrials.gov registry record · Phase 3
Study for Participants With Ulcerative Colitis Previously Enrolled in Etrolizumab Phase II/III Studies
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Terminated
- Registry status
- Phase 3
- Development phase
- 1,822
- Enrollment target
NCT02118584: Clinical Trial Phase 3 study, sponsored by Hoffmann-La Roche.
NCT02118584 is a Phase 3 study that was terminated before completion, run by Hoffmann-La Roche. The registered enrollment target is 1,822 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (136% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02118584, a Phase 3 study, was terminated before completion, sponsored by Hoffmann-La Roche.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 1,822 participants
- Enrollment target
Study Summary
This two-part, part 1: open-label extension (OLE) and part 2: safety monitoring (SM) study will examine the efficacy and safety of continued etrolizumab treatment in moderate to severe ulcerative colitis (UC) participants previously enrolled in etrolizumab Phase II/III studies. Participants with moderate to severe UC who were enrolled in the Phase II OLE study (GA27927 \[NCT01461317\]) or the Phase III studies (GA28948 \[NCT02163759\], GA28949 \[NCT02171429\], GA28950 \[NCT02100696\], GA29102 \[NCT02165215\], and GA29103 \[NCT02136069\]) were included. Participants from the Phase II OLE study or the Phase III studies who are not eligible or willing to receive etrolizumab in the OLE-SM study, and who have completed the 12-week safety follow-up period will be enrolled in Part 2. Part 1 of OLE-SM will continue for up to 9 years after the first participant is enrolled into the study. Following Part 1, participants will enter Part 2 for a period of 92 weeks.
Primary Outcome
The pMCS is a composite of 3 assessments, each rated from 0 (none) to 3 (severe disease): stool frequency, rectal bleeding, and physician's global assessment. The total score for pMCS ranges from 0 (none) to 9 (severe disease). pMCS clinical remission was defined as pMCS ≤ 2, a rectal bleeding score of 0-1, physician's global assessment of 0-1, stool frequency subscore of 0-1. Percentages have been rounded off.
Interventions
- DRUG Etrolizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,822 participants |
| Start Date | 2014-09-15 |
| Est. Completion | 2023-10-05 |
| Phase | Phase 3 |
Why NCT02118584 stopped before completion
NCT02118584 is an interventional study that assigns participants to a tested intervention. Its 1,822 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (136% higher).
The record links to 0 conditions, and to 1 intervention - of which Etrolizumab is the first listed.
NCT02118584 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02118584 about?
NCT02118584 is a clinical study titled "Study for Participants With Ulcerative Colitis Previously Enrolled in Etrolizumab Phase II/III Studies". This two-part, part 1: open-label extension (OLE) and part 2: safety monitoring (SM) study will examine the efficacy and safety of continued etrolizumab treatment in moderate to severe ulcerative colitis (UC) participants previously enrolled in etrolizumab Phase II/III studies. Participants with mod...
What is the current status of trial NCT02118584?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 1,822 participants. The study started on 2014-09-15. Estimated completion is 2023-10-05.
What interventions are being tested in trial NCT02118584?
The interventions under investigation include: Etrolizumab (DRUG).
Who is sponsoring clinical trial NCT02118584?
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 NCT02118584's enrollment target sits among peer trials
1,822 117th of 2000 higher than 1,884 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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