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An Open-label Study of Vedolizumab (MLN0002) in Participants With Ulcerative Colitis and Crohn's Disease

NCT00790933 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2243

Last updated 2022-05-24

Study results available
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Summary

The purpose of this multicenter, open-label study is to collect data on the occurrence of important clinical safety events resulting from chronic vedolizumab (MLN0002) administration.

Conditions

Interventions

DRUG

Vedolizumab

Vedolizumab intravenous infusion

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor Clinical Science · Takeda

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-22
Primary Completion
2017-10-31
Completion
2017-10-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • Czechia
  • Germany
  • Hungary
  • Israel
  • Malaysia
  • South Korea

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00790933 on ClinicalTrials.gov