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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:  NCT02678052
Date of registration: 04/02/2016
Prospective Registration: No
Primary sponsor: Takeda
Public title: OTIS Vedolizumab Pregnancy Exposure Registry
Scientific title: Organization of Teratology Information Specialists (OTIS) Vedolizumab Pregnancy Exposure Registry
Date of first enrolment: December 1, 2015
Target sample size: 300
Recruitment status: Active, not recruiting
URL:  https://clinicaltrials.gov/show/NCT02678052
Study type:  Observational
Study design:   
Phase: 
Countries of recruitment
Canada United States
Contacts
Name:     Medical Director
Address: 
Telephone:
Email:
Affiliation:  Takeda
Key inclusion & exclusion criteria

Inclusion Criteria:

For the UC/CD Prospective Cohort:

1. Is a currently pregnant woman with UC or CD,

2. Has exposure to Entyvio or other biologic agents at any dose, and at any time from
first day of LMP,

3. Has enrolled no later than 19 completed weeks after LMP.

4. Agrees to the conditions and requirements of the study including the interview
schedule, release of medical records, and the physical examination of live born
infants.

For the 'no chronic disease' Prospective Cohort:

5. Is a currently pregnant woman with no chronic disease.

6. Has no exposure to any biological agent and at any time from first day of LMP,

7. Has enrolled no later than 19 completed weeks after LMP.

8. Agrees to the conditions and requirements of the study including the interview
schedule, release of medical records, and the physical examination of live born
infants.

Exclusion Criteria:

For the UC/CD Prospective Cohort:

1. Is greater than (>) 19 completed weeks gestation prior to enrollment,

2. Has first contact with OTIS after prenatal diagnosis of any major structural defect,

3. Has enrolled in this registry with a previous pregnancy,

4. Has had an exposure to the known or suspected human teratogens: Chlorambucil.
Cyclophosphamide, Mycophenylate mofetil.

For the 'no chronic disease' Prospective Cohort:

5. Is >19 completed weeks gestation prior to enrollment,

6. Has first contact with OTIS after prenatal diagnosis of any major structural defect,

7. Has enrolled in this registry with a previous pregnancy,

8. Has had an exposure to the known or suspected human teratogens: Chlorambucil,
Cyclophosphamide, Mycophenylate mofetil.

Note: women exposed to Entyvio during pregnancy but not meeting the above criteria can
enroll into the Entyvio pregnancy exposure case series component of this registry.



Age minimum: 18 Years
Age maximum: 44 Years
Gender: Female
Health Condition(s) or Problem(s) studied
Colitis, Ulcerative
Crohn's Disease
Intervention(s)
Biological: Other Biological Agent
Drug: Vedolizumab
Primary Outcome(s)
Major Structural Birth Defects Identified in Infants After Birth [Time Frame: Baseline up to 1 year]
Secondary Outcome(s)
Minor Structural Birth Defects Identified in Infants After Birth [Time Frame: Baseline up to 1 year]
Secondary ID(s)
Vedolizumab-5001
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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