OTIS Vedolizumab Pregnancy Exposure Registry
Condition: Colitis, Ulcerative; Crohn's Disease
MeSH terms: Crohn Disease; Colitis, Ulcerative
Study type: Observational

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.
    

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.
    

Intervention name(s): Vedolizumab; Other Biological Agent
Intervention type(s): Drug; Biological
Intervention description(s): Vedolizumab exposure; Other Biological Agent exposure
Other intervention name(s): Entyvio
Intervention MeSH terms: Vedolizumab
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        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.
      
Keywords: Drug therapy