Clinical trial NCT02617927: The Safety Assessment of Vedolizumab During Pregnancy in IBD Patient
Official title: The Safety Assessment of Vedolizumab During Pregnancy in IBD Patient
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pregnancy Complications
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2015-12-01
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The source population is women attending the IBD MON clinic at Shaare Zedek Medical Center in Jerusalem, Israel.

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.

Eligibility criteria: Inclusion Criteria for the UC/CD Prospective Cohort:

* 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 for the UC/CD Prospective Cohort:

* 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.

Primary outcomes:
measure: Major body measurements defects of the infant
timeFrame: 1 year from birth
Secondary outcomes:
measure: Minor body measurements defects of the infant
timeFrame: 1 year from birth
Other outcomes:
measure: Rate of Spontaneous abortion
timeFrame: Prior to 20 weeks' gestation post-LMP
measure: Rate of Elective abortion
timeFrame: 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
measure: Rate of Stillbirth
timeFrame: After 20 weeks' gestation post-LMP, but prior to delivery
measure: Rate of Premature delivery
timeFrame: Prior to 37 completed weeks' gestation post-LMP.
measure: Rate of SGA
timeFrame: 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
measure: Rate of Postnatal growth deficiency
timeFrame: The size of the infant at the time of postnatal until 1 year of age
measure: Rate of Lost-to-follow-up following the estimated due date
timeFrame: 12 months following the estimated due date
measure: Rate of Serious or opportunistic infections
timeFrame: Newborn infants up to 1 year of age
measure: Rate of Malignancies
timeFrame: Up to 1 year of age of the infant
Locations:
city: Jerusalem
country: Israel
facility: Shaarey Zedek MC
Study officials:
affiliation: Shaarey Zedek MC
name: Eran Goldin, Professor
role: STUDY_DIRECTOR
References: