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OpenTrials
Completed

NCT Number: NCT03378219

An Observational Study on Sarilumab-exposed Pregnancies

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.

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Key information

Conditions

Rheumatoid Arthritis -Exposure During Pregnancy

Sex eligibility

Female

Study type

Observational

Primary location

CANADA, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Cohort 1: Sarilumab-Exposed Cohort
  • Currently pregnant, exposed to Kevzara (sarilumab) for approved indication
  • Cohort 2: Disease-matched Comparison Cohort
  • Currently pregnant, diagnosed with Kevzara (sarilumab) approved indication
  • Cohort 3: Non-diseased Comparison Cohort
  • Currently pregnant, not diagnosed with a Kevzara (sarilumab) indication and unexposed to Kevzara

Exclusion criteria

First contact the Registry after prenatal diagnosis of any major structural defect or after pregnancy outcome is known (retrospective data).

Enrolled in this cohort study with a previous pregnancy. Cohort 1: Sarilumab-Exposed Cohort

  • Exposed to Kevzara (sarilumab) for an indication other than a currently approved indication.
  • Exposure to another biologic during pregnancy or within 10 weeks prior to the first day of LMP.
  • Exposed to methotrexate, cyclophosphamide, chlorambucil, or mycophenolate mofetil in pregnancy (ie, at any time after the LMP), or leflunomide within two years prior to pregnancy unless a blood level for leflunomide below 0.02 mcg/mL has been documented prior to LMP before the pregnancy.
  • Cohort 2: Disease-matched Comparison Cohort
  • Exposure to any Kevzara (sarilumab) during pregnancy or within 10 weeks prior to the first day of the LMP.
  • Exposed to methotrexate, cyclophosphamide, chlorambucil, or mycophenolate mofetil in pregnancy (ie, at any time after the LMP), or leflunomide within two years prior to pregnancy unless a blood level for leflunomide below 0.02 mcg/mL has been documented prior to LMP before the pregnancy.
  • Cohort 3: Non-diseased Comparison Cohort
  • Diagnosed for any serious chronic disease that is thought to adversely impact pregnancy.
  • Exposed to a known human teratogen during pregnancy as confirmed by the OTIS Research Center

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Treatment and study plan

Sarilumab SAR153191 (REGN88)

Drug

Pharmaceutical form:injection Route of administration: subcutaneous

Other names: Kevzara

Primary outcomes

  1. 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

  1. 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).

  2. 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.

  3. 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).

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Collaborators

  • Regeneron Pharmaceuticals

Registry information

Official study title

Kevzara® (Sarilumab) Pregnancy Exposure Registry: An OTIS Pregnancy Surveillance Study

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Dec 19, 2017
Registry last updated
Jan 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.