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Efficacy and Safety of Vedolizumab Subcutaneous (SC) as Maintenance Therapy in Crohn's Disease (CD)
NCT02611817 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02611817
The ClinicalTrials.gov registry entry for NCT02611817 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 644 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Takeda, which has 387 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02611817 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Florida, Georgia, Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02611817?
This trial is sponsored by Takeda, which has 387 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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