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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: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02674308
Date of registration: 29/01/2016
Prospective Registration: No
Primary sponsor: Takeda
Public title: Entyvio (Vedolizumab) Long Term Safety Study Entyvio PASS
Scientific title: Entyvio (Vedolizumab) Long-term Safety Study: An International Observational Prospective Cohort Study Comparing Vedolizumab to Other Biologic Agents in Patients With Ulcerative Colitis or Crohn's Disease
Date of first enrolment: March 31, 2015
Target sample size: 5302
Recruitment status: Active, not recruiting
URL:  https://clinicaltrials.gov/show/NCT02674308
Study type:  Observational
Study design:   
Phase: 
Countries of recruitment
Austria Belgium Canada Croatia Denmark Estonia France Germany
Greece Ireland Israel Italy Netherlands Norway Portugal Slovenia
Spain Sweden Switzerland United Kingdom United States
Contacts
Name:     Medical Director
Address: 
Telephone:
Email:
Affiliation:  Takeda
Key inclusion & exclusion criteria

Inclusion Criteria:

1. Signed informed consent, by the participant or a legally acceptable representative.

2. Aged at least 18 years.

3. Initiating vedolizumab or another biologic agent for UC or CD.

4. Signed release form, by the participant or a legally acceptable representative,
permitting abstraction of the participant's medical records at Baseline and during
participation in the study.

Exclusion Criteria:

1. The participant is enrolled in a clinical trial in which treatment for CD or UC is
managed through a protocol.

2. Prior treatment with vedolizumab.

3. Any other reason that, in the Investigator's opinion, makes the participant unsuitable
to participate in this study.



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Ulcerative Colitis and Crohn's Disease
Intervention(s)
Drug: Vedolizumab
Other: Other Biologic Agents
Primary Outcome(s)
Percentage of Participants with Adverse Events of Special Interest [Time Frame: 7 years]
Secondary Outcome(s)
Disease Severity in Crohn's Disease (CD) Participants [Time Frame: Baseline and at every 6 months (up to 7 years)]
Disease Severity in Ulcerative Colitis (UC) Participants [Time Frame: Baseline and at every 6 months (up to 7 years)]
Participant Reported Quality of Life Assessment Using 12-Item Short Form Health Survey (SF-12) [Time Frame: Baseline and at every 6 months (up to 7 years)]
Participant Reported Quality of Life Assessment Using Short Inflammatory Bowel Disease Questionnaire (SIBDQ) [Time Frame: Baseline and at every 6 months (up to 7 years)]
Reasons for Treatment Discontinuation [Time Frame: Baseline and at every 6 months (up to 7 years)]
Time to Treatment Discontinuation [Time Frame: Baseline and at every 6 months (up to 7 years)]
Secondary ID(s)
MLN-0002_401
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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