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.
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.
Study Type
OBSERVATIONAL
Enrollment
113
Pharmaceutical form:injection Route of administration: subcutaneous
United States
New York, New York, United States
CANADA
Canada, Canada
Rate of major structural birth defect
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.
Time frame: Up to 1 year of age of the infant
Pregnancy Outcomes: Spontaneous abortion
Spontaneous abortion is defined as non-deliberate embryonic or fetal death that occurs \< 20.0 weeks' gestation post-LMP (Last Menstrual period).
Time frame: Date of conception to 20 weeks gestation
Pregnancy Outcomes: Stillbirth
Stillbirth is defined as a non-deliberate fetal death that occurs at or after 20 weeks of gestation but prior to delivery.
Time frame: After 20 weeks of gestation but prior to delivery
Pregnancy Outcomes: Premature delivery
Premature delivery is defined as live birth prior to 37 weeks' gestation as counted from LMP (Last Menstrual period).
Time frame: Live birth prior to 37 weeks gestation
Infant Outcomes: pattern of minor structural birth defects
A specific pattern of 3 or more structural defects in live born infants with dysmorphological physical examination.
Time frame: Up to 1 year of age of the infant
Infant Outcomes: Small for gestational age
Proportion of infants less than or equal to the 10th percentile for sex and gestational age on weight, length, or head circumference.
Time frame: At birth
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Infant Outcomes: Postnatal growth deficiency
Proportion of infants less than or equal to the 10th percentile for sex and age on weight, length, or head circumference at 1 year postnatal evaluation.
Time frame: Up to 1 year of age of the infant
Infant Outcomes: Serious or opportunistic infections
Proportion of infants who experienced serious or opportunistic infections up to 1 year of age.
Time frame: Up to 1 year of age of the infant
Infant Outcomes: Hospitalizations
Proportion of infants who experienced hospitalizations in the first year of life excluding those that are linked to premature delivery or birth defects included as endpoints.
Time frame: Up to 1 year of age of the infant
Infant Outcomes: Malignancies
Proportion of infants who reported malignancies reported in an infant after birth and up to 1 year of age.
Time frame: Up to 1 year of age of the infant -