- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02678052
OTIS Vedolizumab Pregnancy Exposure Registry
Organization of Teratology Information Specialists (OTIS) Vedolizumab Pregnancy Exposure Registry
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The drug being observed in this study is called Vedolizumab. Vedolizumab is approved for the treatment of adult participants with moderately to severely active UC and CD who achieved an inadequate response, had a loss of response, or were intolerant to conventional and/or biologic treatments. This study will look at any possible association between vedolizumab and pregnancy outcome, including the health of the mother, fetus, and infant in the female with planned and unplanned pregnancies and who are at least 1 dose exposed at any time from last menstrual period (LMP) during pregnancy to vedolizumab (Entyvio) or other biological agents for UC or CD.
The study will enroll approximately 200 pregnant female participants drawn from 3 sources: OTIS Network, pregnant women who spontaneously contact the study research center or the sponsor or who are referred by their health care practitioners (HCP) in North America and women in North America who become pregnant while participating in other Entyvio clinical studies being undertaken by the sponsor. Participants will be assigned to one of the two cohorts:
- No chronic disease prospective cohort
- UC/CD prospective cohort All participants will be observed throughout the study. All participants will be asked to record all medications (including dose, frequency, and route), any additional exposures or events as the pregnancy progresses in a pregnancy diary.
This multi-center trial will be conducted worldwide. The overall time to participate in this study is 6 years. Cohort enrollment will be done before 20 weeks of gestation period and intake interviews would be scheduled telephonically. Schedule of intake interviews of participants will depends upon the duration of LMP prior to enrollment of participants in study. Outcome interview would be conducted within 0 to 6 weeks after delivery, dysmorphological examination of live infants would be conducted within 0 to 12 months after delivery and pediatric medical record review and questionnaire would be held 1 year after delivery.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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California
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San Diego, California, United States
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
Vedolizumab exposure
Other Names:
Other Biological Agent exposure
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Major Structural Birth Defects Identified in Infants After Birth
Time Frame: Baseline up to 1 year
|
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.
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Baseline up to 1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Minor Structural Birth Defects Identified in Infants After Birth
Time Frame: Baseline up to 1 year
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A minor structural defect is defined as a defect that has neither cosmetic nor functional significance to the child (for example: complete 2,3 syndactyly of the toes) and will be identified using a study-related checklist incorporated into the study dysmorphology examination of live born infants.
Baseline will be considered at the time of birth of child.
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Baseline up to 1 year
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Study Director, The Organization of Teratology Information Specialists
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Vedolizumab-5001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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