An Observational Study on Sarilumab-exposed Pregnancies
- Conditions
- Rheumatoid Arthritis -Exposure During Pregnancy
- Interventions
- Registration Number
- NCT03378219
- Lead Sponsor
- Sanofi
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 113
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cohort 1 Sarilumab SAR153191 (REGN88) 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
- Primary Outcome Measures
Name Time Method Rate of major structural birth defect 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 Outcome Measures
Name Time Method Pregnancy Outcomes: Spontaneous abortion Date of conception to 20 weeks gestation Spontaneous abortion is defined as non-deliberate embryonic or fetal death that occurs \< 20.0 weeks' gestation post-LMP (Last Menstrual period).
Pregnancy Outcomes: Stillbirth After 20 weeks of gestation but prior to delivery Stillbirth is defined as a non-deliberate fetal death that occurs at or after 20 weeks of gestation but prior to delivery.
Pregnancy Outcomes: Premature delivery Live birth prior to 37 weeks gestation Premature delivery is defined as live birth prior to 37 weeks' gestation as counted from LMP (Last Menstrual period).
Infant Outcomes: pattern of minor structural birth defects Up to 1 year of age of the infant A specific pattern of 3 or more structural defects in live born infants with dysmorphological physical examination.
Infant Outcomes: Postnatal growth deficiency Up to 1 year of age of the infant 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.
Infant Outcomes: Malignancies Up to 1 year of age of the infant - Proportion of infants who reported malignancies reported in an infant after birth and up to 1 year of age.
Infant Outcomes: Small for gestational age At birth Proportion of infants less than or equal to the 10th percentile for sex and gestational age on weight, length, or head circumference.
Infant Outcomes: Serious or opportunistic infections Up to 1 year of age of the infant Proportion of infants who experienced serious or opportunistic infections up to 1 year of age.
Infant Outcomes: Hospitalizations Up to 1 year of age of the infant 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.
Trial Locations
- Locations (2)
CANADA
🇨🇦Canada, Canada
United States
🇺🇸New York, New York, United States