An Observational Study on Sarilumab-exposed Pregnancies
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|ClinicalTrials.gov Identifier: NCT03378219|
Recruitment Status : Recruiting
First Posted : December 19, 2017
Last Update Posted : August 7, 2019
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.
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.
|Condition or disease||Intervention/treatment|
|Rheumatoid Arthritis -Exposure During Pregnancy||Drug: Sarilumab SAR153191 (REGN88)|
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||Kevzara® (Sarilumab) Pregnancy Exposure Registry: An OTIS Pregnancy Surveillance Study|
|Actual Study Start Date :||May 18, 2018|
|Estimated Primary Completion Date :||August 2027|
|Estimated Study Completion Date :||August 2027|
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
Drug: Sarilumab SAR153191 (REGN88)
Pharmaceutical form:injection Route of administration: subcutaneous
Other Name: Kevzara
Disease-matched Comparison Cohort: Pregnant women diagnosed with Kevzara (sarilumab) approved indication. Approximate frequency matched to the exposed group by disease indication, validated by medical records, who have not been exposed to Kevzara (sarilumab) any time in the current pregnancy, and have taken another biologic DMARD medication for their disease within 2 years before the current pregnancy and have an indication for such treatment at enrollment
Non-diseased Comparison Cohort: Healthy pregnant women not diagnosed with a Kevzara (sarilumab) indication and unexposed to Kevzara (sarilumab) during the course of the pregnancy
- 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.
- Pregnancy Outcomes: Spontaneous abortion [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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: Small for gestational age [ Time Frame: 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: Postnatal growth deficiency [ Time Frame: 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: Serious or opportunistic infections [ Time Frame: 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 [ Time Frame: 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.
- Infant Outcomes: Malignancies [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03378219
|Contact: Trial Transparency email recommended (Toll free number for US & Canada)||800-633-1610 ext 1 then #||Contact-US@sanofi.com|
|United States, New York|
|New York, New York, United States, 00000|
|Study Director:||Clinical Sciences & Operations||Sanofi|