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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: Completed Phase 3 study, sponsored by Takeda.
NCT02611830 is a Phase 3 study that has completed, run by Takeda. The registered enrollment target is 383 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Clinical remission is defined as a complete Mayo score ≤ 2 points and no individual subscore \> 1 point. The Mayo score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 subscores: rectal bleeding, stool frequency, findings on endoscopy, and physician's global assessment. Each subscore is scored on a scale from 0 to 3 and the complete Mayo score ranges from 0 to 12 (higher scores indicate greater disease activity).
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 |
What the finished NCT02611830 record still lists
NCT02611830 is an interventional study that assigns participants to a tested intervention. The registered 383 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo IV is the first listed.
NCT02611830 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02611830's enrollment target sits among peer trials
383 976th of 2000 higher than 1,023 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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