OTIS Vedolizumab Pregnancy Exposure Registry
Organization of Teratology Information Specialists (OTIS) Vedolizumab Pregnancy Exposure Registry
2 other identifiers
observational
303
1 country
1
Brief Summary
The purpose of this study is to assess the prevalence of major structural birth defects in infants of female participants with ulcerative colitis (UC) or Crohn's disease (CD) exposed to vedolizumab during pregnancy, compared to participants with UC or CD exposed to other biologic agents.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2015
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 4, 2016
CompletedFirst Posted
Study publicly available on registry
February 9, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2022
CompletedOctober 8, 2024
October 1, 2024
6.6 years
February 4, 2016
October 4, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Major Structural Birth Defects Identified in Infants After Birth
A major structural defect is defined as a defect that has either cosmetic or functional significance to the child (eg, a cleft lip), as defined by the Centers for Disease Control and Prevention (CDC). These defects in aggregate typically occur in less than (\<) 4% of the general population. Over 100 specific structural defects are considered to be major. Baseline will be considered as the time of birth of child.
Baseline up to 1 year
Secondary Outcomes (1)
Minor Structural Birth Defects Identified in Infants After Birth
Baseline up to 1 year
Study Arms (2)
Cohort 1: No Chronic Disease
Pregnant women without a current diagnosis of any chronic disease with no exposure to any biological agent and at any time from first day of last menstrual period (LMP) will be observed for up to 1 year.
Cohort 2: UC/CD Prospective Cohort
Pregnant women with current diagnosis of UC or CD with exposure to Entyvio or other biologic agents during pregnancy at any dose, and at any time from first day of LMP will be observed for up to 1 year.
Interventions
Eligibility Criteria
Pregnant woman with or without UC or CD with exposure to Entyvio or any other biological agent (only for women with UC or CD) during pregnancy will be observed in this study.
You may qualify if:
- For the UC/CD Prospective Cohort:
- Is a currently pregnant woman with UC or CD,
- Has exposure to Entyvio or other biologic agents at any dose, and at any time from first day of LMP,
- Has enrolled no later than 19 completed weeks after LMP.
- 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:
- Is a currently pregnant woman with no chronic disease.
- Has no exposure to any biological agent and at any time from first day of LMP,
- Has enrolled no later than 19 completed weeks after LMP.
- 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.
You may not qualify if:
- For the UC/CD Prospective Cohort:
- Is greater than (\>) 19 completed weeks gestation prior to enrollment,
- Has first contact with OTIS after prenatal diagnosis of any major structural defect,
- Has enrolled in this registry with a previous pregnancy,
- Has had an exposure to the known or suspected human teratogens: Chlorambucil. Cyclophosphamide, Mycophenylate mofetil.
- For the 'no chronic disease' Prospective Cohort:
- Is \>19 completed weeks gestation prior to enrollment,
- Has first contact with OTIS after prenatal diagnosis of any major structural defect,
- Has enrolled in this registry with a previous pregnancy,
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
- The Organization of Teratology Information Specialistscollaborator
Study Sites (1)
Unknown Facility
San Diego, California, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
- STUDY DIRECTOR
Study Director
The Organization of Teratology Information Specialists
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2016
First Posted
February 9, 2016
Study Start
December 1, 2015
Primary Completion
July 15, 2022
Study Completion
July 31, 2022
Last Updated
October 8, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Access Criteria
- IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.