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

• Register: EUCTR
• Last refreshed on: 21 July 2021
• Main ID: EUCTR2016-000678-40-HU
• Date of registration: 19/05/2016
• 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: 07/07/2016
• Target sample size: 385
• Recruitment status: Authorised-recruitment may be ongoing or finished
• 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, Czechia, 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
• Affiliation: Takeda Development Centre Europe Limited

• Name: Global Medical Affairs
• 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.

PK Substudy:
5. Received vedolizumab during participation in the C13008 protocol.
6. The subject will start the main XAP study on Q8W dosing.
7. The subject or, when applicable, the subject’s legally acceptable representative, has signed and dated a written ICF for the procedures related to the XAP-PK substudy.
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)

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

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

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

Vedolizumab-4013

NCT02743806

Source(s) of Monetary Support

Takeda Development Centre Americas, Inc.

Ethics review

Status: Approved
Approval date: 27/06/2016
Contact: