Clinical Trial Details

NCT ID: NCT02743806
Date Last Changed: May 11, 2017

Overview

Research Study Summary

A clinical trial to evaluate treatments using Vedolizumab for patients with Colitis, Ulcerative or Crohn Disease

Research Study Title

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

Purpose

The purpose of this study is to monitor ongoing safety in subjects with ulcerative colitis (UC) and Crohn's disease (CD) and to provide access to vedolizumab for qualifying subjects who, in the opinion of the investigator, continue to derive benefit from vedolizumab and for whom continued treatment with vedolizumab is desired because there is no other comparable product available or the subject may be expected to develop worsening of disease if they were to modify treatment.

To Learn more

Recruitment Details

Phase
4
Gender
All
Age
18 to 90 Years
Overall Status
Recruiting
Lead Sponsor
Takeda
Duration
52 Months
Facility Type
N/A
Compensation

Eligibility

All ages 18 Years to 90 Years

Inclusion Criteria:

  1. Received vedolizumab (excluding comparator or placebo participants) during participation in a qualifying vedolizumab study.

  2. 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.

  3. 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.

  4. 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.

Exclusion Criteria:

  1. For the participant's particular clinical scenario, vedolizumab is currently available to the participant through commercial channels, including reimbursement.

  2. 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.

  3. 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.

  4. If male, the participant intends to donate sperm during the course of this study or for 18 weeks thereafter.

  5. Has received a live vaccine in the last 18 weeks or is in need of a live vaccine during the study or up to 18 weeks after the last study dose.

Site Locations (24)

Country State City Zip Facility and Contact
Australia Australian Capital Territory Garran Research Site
Bulgaria Sofia-Grad Sofia Research Site
Czechia Jihocesky kraj Strakonice Research Site
Czechia Kralovehradecky kraj Hradec Kralove Research Site
Czechia Pardubicky kraj Pardubice Research Site
Czechia Karlovy Vary Research Site
Czechia Kladno Research Site
Czechia Praha 10 Research Site
Czechia Praha 7 Research Site
Czechia Tabor Research Site
Czechia Usti Nad Labem Research Site
Estonia Tallinn Research Site
Hungary Bekescsaba Research Site
Hungary Dunaujvaros Research Site
Hungary Gyula Research Site
Hungary Kaposvar Research Site
Hungary Szekesfehervar Research Site
Hungary Szekszard Research Site
Italy Rozzano (MI) Research Site
Korea, Republic of Daegu Research Site
Korea, Republic of Seoul Research Site
Latvia Riga Research Site
New Zealand South Island Christchurch Research Site
Romania Bucharest Research Site

Contact

Takeda Study Registration Call Center
+1-877-825-3327
E-mail:

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