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COMPLETED Phase 3

An Efficacy and Safety Study of Vedolizumab Intravenous (IV) Compared to Adalimumab Subcutaneous (SC) in Participants With Ulcerative Colitis

NCT02497469 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study is to evaluate the efficacy and safety of vedolizumab intravenous (IV) treatment compared to adalimumab subcutaneous (SC) treatment over a 52-week treatment period.

Conditions Studied

Interventions

  • DRUG Adalimumab
  • DRUG Vedolizumab
  • DRUG Adalimumab placebo
  • DRUG Vedolizumab placebo

Study Locations (20)

Florida

  • Innovative Medical Research of South Florida, Inc. — Aventura
  • Advanced Clinical Research of Miami — Doral
  • Wellness Clinical Research — Hialeah Gardens
  • Nature Coast Clinical Research, LLC — Inverness
  • Florida Center for Gastroenterology — Largo
  • Gastro Health — Miami
  • Medical Professional Clinical Research — Miami
  • Tellus Clinical Research, Inc. — Miami
  • South Florida Research Phase I-IV — Miami Springs
  • Gastroenterology Group of Naples — Naples
  • Internal Medicine Specialists — Orlando
  • BRCR Medical Center, Inc. — Plantation

California

  • WCCT Global (PH 1 Unit) — Costa Mesa
  • California Medical Research Associates Inc. — Northridge
  • Sutter Institute for Medical Research — Sacramento

Alabama

  • IMC - Diagnostic and Medical Clinic — Mobile

Arizona

  • Arizona Arthritis & Rheumatology Research, PLLC — Phoenix

Arkansas

  • Arkansas Primary Care Clinic, PA — Little Rock

Colorado

  • Rocky Mountain Gastroenterology — Lakewood

Connecticut

  • Medical Research Center of Connecticut, LLC — Hamden

Trial Details

FieldValue
Enrollment Target 771 participants
Start Date 2015-06-29
Est. Completion 2019-01-18
Phase Phase 3

Sponsor

Takeda

387 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02497469

The ClinicalTrials.gov registry entry for NCT02497469 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 771 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 Colitis, Ulcerative appearing as the primary indexed condition, and to 4 interventions — of which Adalimumab 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: NCT02497469 reports 20 study locations spanning 7 distinct geographic areas — top geographies include Florida, California, Alabama. 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 NCT02497469 about?

NCT02497469 is a clinical study titled "An Efficacy and Safety Study of Vedolizumab Intravenous (IV) Compared to Adalimumab Subcutaneous (SC) in Participants With Ulcerative Colitis". The purpose of this study is to evaluate the efficacy and safety of vedolizumab intravenous (IV) treatment compared to adalimumab subcutaneous (SC) treatment over a 52-week treatment period.

What is the current status of trial NCT02497469?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 771 participants. The study started on 2015-06-29. Estimated completion is 2019-01-18.

What conditions does trial NCT02497469 study?

This clinical trial studies the following conditions: Colitis, Ulcerative. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02497469?

The interventions under investigation include: Adalimumab (DRUG), Vedolizumab (DRUG), Adalimumab placebo (DRUG), Vedolizumab placebo (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02497469?

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 NCT02497469 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial