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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 is a Phase 3 study that was terminated before completion, run by Hoffmann-La Roche. The registered enrollment target is 1,822 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02118584
The ClinicalTrials.gov registry entry for NCT02118584 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 1,822 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Etrolizumab is the first listed.
NCT02118584 reports 0 study locations.
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.
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