OTIS Vedolizumab Pregnancy Exposure Registry
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|ClinicalTrials.gov Identifier: NCT02678052|
Recruitment Status : Active, not recruiting
First Posted : February 9, 2016
Last Update Posted : September 28, 2021
|Condition or disease||Intervention/treatment|
|Colitis, Ulcerative Crohn's Disease||Drug: Vedolizumab Biological: Other Biological Agent|
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 :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||Organization of Teratology Information Specialists (OTIS) Vedolizumab Pregnancy Exposure Registry|
|Actual Study Start Date :||December 1, 2015|
|Estimated Primary Completion Date :||November 30, 2022|
|Estimated Study Completion Date :||August 31, 2023|
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.
Other Name: Entyvio
Biological: Other Biological Agent
Other Biological Agent exposure
- 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.
- Minor Structural Birth Defects Identified in Infants After Birth [ Time Frame: Baseline up to 1 year ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02678052
|United States, California|
|San Diego, California, United States|
|Multiple Locations, Canada|
|Study Director:||Medical Director||Takeda|