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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 25 August 2020
Main ID:  EUCTR2016-000678-40-BG
Date of registration: 01/11/2016
Prospective Registration: Yes
Primary sponsor: Takeda Development Centre Europe Limited
Public title: Program to allow continuation of treatment with Entyvio (Vedolizumab IV) for patients with ulcerative colitis and Chron´s disease who previously participated in a clinical trial with this same treatment
Scientific title: Entyvio (Vedolizumab IV) Extended Access Program in Ulcerative Colitis and Crohn’s Disease
Date of first enrolment: 05/01/2017
Target sample size: 385
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-000678-40
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: no
Randomised: no
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
Number of treatment arms in the trial: 1
 
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes
Countries of recruitment
Australia Bulgaria Czech Republic Estonia Hungary India Italy Korea, Republic of
Latvia Malaysia New Zealand Poland Romania Russian Federation Serbia Slovakia
South Africa Taiwan Turkey Ukraine
Contacts
Name: Global Medical Affairs   
Address:  1 Kingdom street W2 6BD London United Kingdom
Telephone: 441256 894003
Email: Stephen.Jones@takeda.com
Affiliation:  Takeda Development Centre Europe Limited
Name: Global Medical Affairs   
Address:  1 Kingdom street W2 6BD London United Kingdom
Telephone: 441256 894003
Email: Stephen.Jones@takeda.com
Affiliation:  Takeda Development Centre Europe Limited
Key inclusion & exclusion criteria
Inclusion criteria:
Any subject who meets the inclusion criteria for the qualifying vedolizumab clinical studies and meets any of the following criteria will qualify for entry into the study:
1. Received vedolizumab (excluding comparator or placebo subjects) during participation in a qualifying vedolizumab study.
2. In the opinion of the investigator, the subject is continuing to derive benefit from vedolizumab and 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.
3. A male subject who is nonsterilized 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 subject of childbearing potential who is sexually active with a nonsterilized 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 380
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion criteria:
Any subject who meets any of the exclusion following criteria will not qualify for entry into the study:
1. For the subject’s particular clinical scenario, vedolizumab is currently available to the subject through commercial channels, including reimbursement.
2. Subject has any clinical condition or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for the study or unable to comply with the dosing requirements or poses a risk to the subject being in the study.
3. If female, the subject 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 subject intends to donate sperm during the course of this study or for 18 weeks thereafter.
5. Subject 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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Ulcerative Colitis and Crohn’s Disease
MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856
MedDRA version: 20.0 Level: LLT Classification code 10013099 Term: Disease Crohns System Organ Class: 100000004856
Intervention(s)

Trade Name: Entyvio
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: vedolizumab
CAS Number: 943609-66-3
Current Sponsor code: MLN0002
Other descriptive name: VEDOLIZUMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-

Primary Outcome(s)
Main Objective: To monitor ongoing safety in subjects with ulcerative colitis and Crohn´s disease 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
Primary end point(s): * Number and percentage of subjects with adverse events (AEs) and serious AEs (SAEs)
* Number and percentage of subjects with adverse events of special interest (AESIs)
Secondary Objective: Not applicable
Timepoint(s) of evaluation of this end point: Continuous
Secondary Outcome(s)
Secondary end point(s): Not applicable
Timepoint(s) of evaluation of this end point: Not applicable
Secondary ID(s)
2016-000678-40-LV
NCT02743806
Vedolizumab-4013
Source(s) of Monetary Support
Takeda Development Centre Americas, Inc.
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 05/01/2017
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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