Vedolizumab-5001: Organization of Teratology Information Specialists (OTIS) Vedolizumab Pregnancy Exposure Registry

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/49443
• EU PAS number:
  EUPAS11681
• Study ID:
  49443
• Official title and acronym:
  Vedolizumab-5001: Organization of Teratology Information Specialists (OTIS) Vedolizumab Pregnancy Exposure Registry
• DARWIN EU® study:
  No
• Study countries:
  Canada

  United States
• Study description:
  This is a prospective, multicenter observational cohort study of pregnant women with ulcerative colitis (UC) and Crohn's disease (CD),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 purpose of this study is to monitor planned and unplanned pregnancies in UC or CD female patients exposed to vedolizumab and to evaluate any possible association between this medication and pregnancy outcome, including the health of the mother, fetus, and infant. The study population of pregnant women would be 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. The planned total duration of the study is 6 years and cohort enrollment will be done before 20 weeks of gestation period and intake interviews would be scheduled telephonically. If subject is enrolled and intake interview is conducted between 16 and 20 week’s gestation, only one interim interview will be conducted during pregnancy at 32-34 week’s gestation. 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 status:
  Finalised

Research institutions and networks

Institutions

Organization of Teratology Information Specialists (OTIS)

Study timelines

Date when funding contract was signed

Planned: 01/10/2015

Actual: 20/11/2015

Study start date

Planned: 30/10/2015

Actual: 01/12/2015

Data analysis start date

Planned: 01/12/2022

Date of final study report

Planned: 30/06/2023

Actual: 02/06/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Takeda

Study protocol

Updated protocol

Vedolizumab-5001 Protocol Version 1 2015-10-05.pdf

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only