The Safety Assessment of Vedolizumab During Pregnancy in IBD Patient

NCT ID: NCT02617927

Last Updated: 2019-05-02

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2021-12-31

Brief Summary

The safety assessment of Vedolizumab during pregnancy in IBD patients.

The primary objective of this study is:

1. To quantify incidence of major structural birth defects and other birth outcomes in infants born to women with UC/CD with exposure to Entyvio compared to women with exposure to other biological agents or conventional IBD therapy during pregnancy

2. To assess the health and developmental status of infants up to 1yr of age.

Detailed Description

The IBD MOM clinic currently follows women with IBD from the preconception stage through postpartum period. In addition, we have now started following the offspring for 1 year with an option of extending the follow up until 4 years after birth with participation of the family health center. Data is collected longitudinally on use of non-immunomodulator medications, AZA/6MP, biologic therapy infliximab, adalimumab, certolizumab, and natalizumab. Corticosteroids,5-ASA and Methotrexate), disease activity during gestation, complications of pregnancy and delivery, and infant birth outcomes during the first year of the child's life because from population-based data, including the Kaiser sample1 and studies from Europe2-4 women with IBD clearly have an increased risk of adverse pregnancy outcomes such as preterm birth and/or low birth weight infants, even with inactive disease.10.

Study duration: September 2015- September 2022 This is a non-interventional observational prospective cohort study to be conducted in an actual clinical practice setting.

This is an exposure-based cohort study in which there will be 3 reference groups. Women on conventional therapy only, women on Vedolizumab and women on other biologics.

The source database contains information collected from our IBD MOM clinic in Shaare Zedek Medical Center in Jerusalem, Israel.

Conditions

Pregnancy Complications

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Vedolizumab Cohort

• Group 1a Mothers exposed to Vedolizumab at any time during pregnancy (and up to 3 months prior to last menstrual period [LMP], if this information is available).
• Group 1b Infants born to Group 1a patients.

No interventions assigned to this group

Anti-TNF Agents Cohort

• Group 2a Patients with IBD who were exposed to anti-TNFs at any time during pregnancy (and up to 3 months prior to LMP, if this information is available).
• Group 2b Infants born to Group 2a patients.

No interventions assigned to this group

Conventional therapy only Cohort

Patients with IBD who were exposed to conventional therapy only any time during pregnancy (and up to 3 months prior to LMP, if this information is available).

• Group 3b Infants born to Group 3a patients.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• The subject is a currently pregnant woman with UC or CD
• The subject has exposure to Entyvio or other biologic agents or conventional therapy (non-biological therapy) at any dose, and at any time from first day of LMP, The subject enrolls no later than 19 completed weeks after LMP.
• All pregnancies in Entyvio users will be included in the study. Those recruited prior to Week 20 will be entered into the prospective registry, and those recruited after week 20 (included retrospective reports after delivery) will be entered into the separate Case Series.
• The subject 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

• The subject is >19 completed weeks gestation prior to enrollment,
• The subject has first contact with OTIS after prenatal diagnosis of any major structural defect,
• The subject has enrolled in this registry with a previous pregnancy,
• The subject has had an exposure to the known or suspected human teratogens:

• Chlorambucil
• Cyclophosphamide
• Mycophenylate mofetil

Any Entyvio exposed mother who does not meet the entry criteria will be entered into an Entyvio case series, which will be used to provide support data to cohort study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ariella Shitrit

OTHER

Sponsor Role: lead

Responsible Party

Ariella Shitrit

Dr Ariella Shitrit

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Eran Goldin, Professor

Role: STUDY_DIRECTOR

Shaarey Zedek MC

Locations

Shaarey Zedek MC

Jerusalem, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Ariella Shitrit, PHD

Role: CONTACT

ariellash@szmc.org.il

972-2-6555555 ext. 216

Facility Contacts

Ariellah Shitrit, PHD

Role: primary

ariellash@szmc.org.il

972-2-655555 ext. 216

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

szmc 2015-001

Identifier Type: -

Identifier Source: org_study_id