Suspended

Entyvio (Vedolizumab IV) Extended Access Program in Ulcerative Colitis and Crohn's Disease

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What is being tested

Vedolizumab

Drug
Who is being recruted

Colitis+6

+ Colitis, Ulcerative

+ Colonic Diseases

From 18 to 90 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: August 2016
See protocol details

Summary

Principal SponsorTakeda
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2016

Actual date on which the first participant was enrolled.

The drug being used in this study is called vedolizumab, which is being used to treat people who have ulcerative colitis or Crohn's disease. This study will monitor ongoing safety in the people who take vedolizumab. Participants who have successfully completed the participation in qualifying vedolizumab clinical studies will be enrolled and assigned to receive: • Vedolizumab 300 mg All participants will receive an intravenous (IV) infusion once every 8 weeks until vedolizumab is available through commercial channels, including reimbursement, for the participant's clinical scenario, or until participant withdrawal, whichever comes first. (Per MM approval, dosing regimen may be modified) This multicenter trial will be conducted worldwide. Participants will make multiple visits to the clinic and a final visit at 18 weeks after receiving the last dose of study infusion of vedolizumab for a safety follow-up assessment.

Official TitleEntyvio (Vedolizumab IV) Extended Access Program in Ulcerative Colitis and Crohn's Disease
NCT02743806
Principal SponsorTakeda
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

331 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 90 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ColitisColitis, UlcerativeColonic DiseasesCrohn DiseaseDigestive System DiseasesGastroenteritisGastrointestinal DiseasesIntestinal DiseasesInflammatory Bowel Diseases

Criteria

4 inclusion criteria required to participate
Received vedolizumab (excluding comparator or placebo participants) during participation in a qualifying vedolizumab study.
In the opinion of the investigator, the participant is continuing to derive benefit from vedolizumab and continued treatment with vedolizumab is desired because there is no other comparable product available or the participant may be expected to develop worsening of disease if they were to modify treatment.
A male participant who is non-sterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 18 weeks after last dose.
A female participant of childbearing potential who is sexually active with a non-sterilized male partner agrees to use routinely adequate contraception from signing of informed consent throughout the duration of the study and for 18 weeks after last dose.
5 exclusion criteria prevent from participating
For the participant's particular clinical scenario, vedolizumab is currently available to the participant through commercial channels, including reimbursement.
Has any clinical condition or prior therapy that, in the opinion of the investigator, would make the participant unsuitable for the study or unable to comply with the dosing requirements or poses a risk to the participant being in the study.
If female, the participant is pregnant or lactating or intending to become pregnant before, during, or within 18 weeks after participating in this study; or intending to donate ova during such time period.
If male, the participant intends to donate sperm during the course of this study or for 18 weeks thereafter.
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Vedolizumab 300 mg, IV infusion, once every 8 weeks (Q8W) that maybe reduced to once every 4 weeks (Q4W) based on the investigator's judgment of participant's clinical status and acknowledged by the medical monitor for up to 6 years.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 78 locations

Suspended

Colentina Clinical Hospital

Bucharest, RomaniaOpen Colentina Clinical Hospital in Google Maps
Suspended

The Canberra Hospital

Garran, Australia
Suspended

Western Hospital

Footscray, Australia
Suspended

Cabrini Medical Centre

Malvern, Australia
Suspended78 Study Centers