Last updated on June 2017

OTIS Vedolizumab Pregnancy Exposure Registry


Brief description of study

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 Study 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.

Clinical Study Identifier: NCT02678052

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