OTIS Vedolizumab Pregnancy Exposure Registry

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Organization of Teratology Information Specialists (OTIS) Vedolizumab Pregnancy Exposure Registry

Conditions
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Colitis, Ulcerative, Crohn's Disease

Intervention / Treatment
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* Drug: Vedolizumab
* Biological: Other Biological Agent


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1: No Chronic Disease<br>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<br>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. | Drug: Vedolizumab<br>* Vedolizumab exposure<br>* Other names: Entyvio;Biological: Other Biological Agent<br>* Other Biological Agent exposure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minor Structural Birth Defects Identified in Infants After Birth | 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. | Baseline up to 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug therapy