Kevzara® (Sarilumab) Pregnancy Exposure Registry: An OTIS Pregnancy Surveillance Study
Overview
- Phase
- Not Applicable
- Intervention
- Sarilumab SAR153191 (REGN88)
- Conditions
- Rheumatoid Arthritis -Exposure During Pregnancy
- Sponsor
- Sanofi
- Enrollment
- 113
- Locations
- 2
- Primary Endpoint
- Rate of major structural birth defect
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
Primary Objective:
To evaluate the relative risk of major structural birth defects, specifically a pattern of anomalies, in sarilumab-exposed pregnancies compared to disease-matched unexposed pregnancies.
Secondary Objective:
To evaluate the risk for sarilumab-exposure relative to the group of healthy pregnant women, and the effect of exposure on other adverse pregnancy and infants outcomes.
Detailed Description
Pregnant women enrolled in the study will participate for the duration of that pregnancy. Those who deliver at least one live born infant and the infants will participate for 1 year after delivery of that infant.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Cohort 1
Sarilumab-Exposed Cohort: Pregnant women exposed to Kevzara (sarilumab) for the treatment of an approved Kevzara (sarilumab) indication, for any number of days, at any dose, and at any time from the first day of the last menstrual period (LMP) up to and including the end of pregnancy
Intervention: Sarilumab SAR153191 (REGN88)
Outcomes
Primary Outcomes
Rate of major structural birth defect
Time Frame: Up to 1 year of age of the infant
A major structural birth defect is a defect that has either cosmetic or functional significance to the child (eg, a cleft lip) and is identified up to one year of age by the mother, the health care provider/medical record, or identified in the dysmorphological examination.
Secondary Outcomes
- Pregnancy Outcomes: Spontaneous abortion(Date of conception to 20 weeks gestation)
- Pregnancy Outcomes: Stillbirth(After 20 weeks of gestation but prior to delivery)
- Pregnancy Outcomes: Premature delivery(Live birth prior to 37 weeks gestation)
- Infant Outcomes: pattern of minor structural birth defects(Up to 1 year of age of the infant)
- Infant Outcomes: Postnatal growth deficiency(Up to 1 year of age of the infant)
- Infant Outcomes: Malignancies(Up to 1 year of age of the infant -)
- Infant Outcomes: Small for gestational age(At birth)
- Infant Outcomes: Serious or opportunistic infections(Up to 1 year of age of the infant)
- Infant Outcomes: Hospitalizations(Up to 1 year of age of the infant)