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NCT02611830 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Vedolizumab Subcutaneously (SC) as Maintenance Therapy in Ulcerative Colitis
A Phase 3 study, sponsored by Takeda.
- Completed
- Registry status
- Phase 3
- Development phase
- 383
- Enrollment target
NCT02611830 is a Phase 3 study that has completed, run by Takeda. The registered enrollment target is 383 participants.
The verdict
NCT02611830, a Phase 3 study, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 383 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the effect of vedolizumab subcutaneous (vedolizumab SC) maintenance treatment on clinical remission at Week 52 in participants with moderately to severely active ulcerative colitis (UC) who achieved clinical response following administration of vedolizumab intravenous (vedolizumab IV) induction therapy.
Interventions
- DRUG Placebo IV
- DRUG Placebo SC
- DRUG Vedolizumab 300 mg IV
- DRUG Vedolizumab 108 mg SC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 383 participants |
| Start Date | 2015-12-18 |
| Est. Completion | 2018-08-21 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02611830
The ClinicalTrials.gov registry entry for NCT02611830 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 383 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Takeda, which has 408 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo IV is the first listed.
NCT02611830 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02611830 about?
NCT02611830 is a clinical study titled "Efficacy and Safety of Vedolizumab Subcutaneously (SC) as Maintenance Therapy in Ulcerative Colitis". The purpose of this study is to assess the effect of vedolizumab subcutaneous (vedolizumab SC) maintenance treatment on clinical remission at Week 52 in participants with moderately to severely active ulcerative colitis (UC) who achieved clinical response following administration of vedolizumab intr...
What is the current status of trial NCT02611830?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 383 participants. The study started on 2015-12-18. Estimated completion is 2018-08-21.
What interventions are being tested in trial NCT02611830?
The interventions under investigation include: Placebo IV (DRUG), Placebo SC (DRUG), Vedolizumab 300 mg IV (DRUG), Vedolizumab 108 mg SC (DRUG).
Who is sponsoring clinical trial NCT02611830?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
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