The Safety Assessment of Vedolizumab During Pregnancy in IBD Patient

NCT02617927 | Unknown

• 1 other identifier: szmc 2015-001
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The safety assessment of Vedolizumab during pregnancy in IBD patients. The primary objective of this study is:

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

Conditions

Pregnancy Complications

Outcome Measures

Primary Outcomes (1)

• Major body measurements defects of the infant

  A major Body measurements 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; \[4\]). These defects in aggregate typically occur in \<4% of the general population. Over 100 specific structural defects are considered to be major. Measurements of head circumference, length, weight, palpebral fissure length, inner canthal distance, ear length, and philtrum length will be taken. These will be compared to mean values for infants of the same age and sex (where sex-specific normative data are available). Less than or greater than 2 standard deviations from the mean will be used to define such terms as microcephaly, hypertelorism, etc.

  1 year from birth

Secondary Outcomes (1)

• Minor body measurements defects of the infant

  1 year from birth

Other Outcomes (9)

• Rate of Spontaneous abortion

  Prior to 20 weeks' gestation post-LMP

• Rate of Elective abortion

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

• Rate of Stillbirth

  After 20 weeks' gestation post-LMP, but prior to delivery

Study Arms (3)

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.

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.

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.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The source population is women attending the IBD MON clinic at Shaare Zedek Medical Center in Jerusalem, Israel.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ariella Shitrit: lead

Study Sites (1)

Shaarey Zedek MC

Jerusalem, Israel

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood, Stool, Urine \& Spit

MeSH Terms

Conditions

Pregnancy Complications

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Eran Goldin, Professor

  Shaarey Zedek MC

  STUDY DIRECTOR

Central Study Contacts

Ariella Shitrit, PHD

CONTACT

972-2-6555555; ariellash@szmc.org.il

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr Ariella Shitrit

Study Record Dates

• First Submitted: November 19, 2015
• First Posted: December 1, 2015
• Study Start: October 1, 2015
• Primary Completion: March 1, 2021
• Study Completion: December 1, 2021
• Last Updated: May 2, 2019

Record last verified: 2019-04

Locations

IL (1)