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NCT02611817 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Vedolizumab Subcutaneous (SC) as Maintenance Therapy in Crohn's Disease (CD)
A Phase 3 study of Crohn's Disease, sponsored by Takeda.
- Completed
- Registry status
- Phase 3
- Development phase
- 644
- Enrollment target
- 20
- Study locations
NCT02611817: Completed Phase 3 study of Crohn's Disease, sponsored by Takeda.
NCT02611817 is a Phase 3 study of Crohn's Disease that has completed, run by Takeda. The registered enrollment target is 644 participants, below the 2,388-participant average among 105 other Crohn's Disease trials with a reported enrollment target (73% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02611817, a Phase 3 study of Crohn's Disease, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 644 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to assess the effect of vedolizumab subcutaneous (vedolizumab SC) as maintenance treatment in participants with moderately to severely active CD who achieved clinical response following administration of vedolizumab intravenous (vedolizumab IV) induction therapy.
Primary Outcome
Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score less than or equal to (\<=) 150 at Week 52. A CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days includes participant reported symptoms, physician-assessed signs, and laboratory markers. CDAI score is equal to (=) sum of weighted scores for subjective items (number of liquid/soft stools, degree of abdominal pain, general well-being); and objective items (use of anti
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Vedolizumab SC 108 mg
- DRUG Vedolizumab IV 300 mg
Study Locations (20)
Florida
- Nature Coast Clinical Research, LLC - Inverness
- L & L Research Choices, Inc. - Miami
- Gastroenterology Group of Naples - Naples
- Shafran Gastroenterology Center - Winter Park
Georgia
- Atlanta Gastroenterology Associates - Atlanta
- Gastroenterology Associates of Central Georgia - Macon
- Atlanta Gastroenterology Specialists, PC - Suwanee
Connecticut
- Medical Research Center of Connecticut, LLC - Hamden
- Middlesex Gastroenterology Associates - Middletown
Illinois
- Rush University Medical Center - Chicago
- Carle Foundation Hospital - Urbana
Louisiana
- Gastroenterology Associates, LLC - Baton Rouge
- Louisiana Research Center, LLC - Shreveport
Michigan
- Clinical Research Institute of Michigan, LLC - Chesterfield
- Gastroenterology Associates of Western Michigan, P.L.C. - Wyoming
Arizona
- Arizona Arthritis & Rheumatology Research, PLLC - Phoenix
Idaho
- Grand Teton Research Group, PLL - Idaho Falls
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 644 participants |
| Start Date | 2016-01-04 |
| Est. Completion | 2019-08-06 |
| Phase | Phase 3 |
What the finished NCT02611817 record still lists
NCT02611817 is an interventional study that assigns participants to a tested intervention. The registered 644 participants enrollment target is mid-sized for trials with a published cap, below the 2,388-participant average among 105 other Crohn's Disease trials with a reported enrollment target (73% lower).
The record links to 1 condition, with Crohn's Disease appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT02611817 names 20 study sites across 11 states, led by Florida, Georgia, Connecticut.
Frequently Asked Questions
What is clinical trial NCT02611817 about?
NCT02611817 is a clinical study titled "Efficacy and Safety of Vedolizumab Subcutaneous (SC) as Maintenance Therapy in Crohn's Disease (CD)". The purpose of this study is to assess the effect of vedolizumab subcutaneous (vedolizumab SC) as maintenance treatment in participants with moderately to severely active CD who achieved clinical response following administration of vedolizumab intravenous (vedolizumab IV) induction therapy.
What is the current status of trial NCT02611817?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 644 participants. The study started on 2016-01-04. Estimated completion is 2019-08-06.
What conditions does trial NCT02611817 study?
This clinical trial studies the following conditions: Crohn's Disease.
What interventions are being tested in trial NCT02611817?
The interventions under investigation include: Placebo (DRUG), Vedolizumab SC 108 mg (DRUG), Vedolizumab IV 300 mg (DRUG).
Who is sponsoring clinical trial NCT02611817?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02611817 being conducted?
This trial has 20 study locations across Arizona, Connecticut, Florida, Georgia, Idaho. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02611817's enrollment target sits among peer trials
644 20th of 105 higher than 86 of 105 other Crohn's Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Crohn's Disease 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.
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