Clinical trial NCT03378219: An Observational Study on Sarilumab-exposed Pregnancies
Official title: Kevzara® (Sarilumab) Pregnancy Exposure Registry: An OTIS Pregnancy Surveillance Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis -Exposure During Pregnancy
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2017-12-19
Enrollment: 113
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of major structural birth defect
timeFrame: Up to 1 year of age of the infant
Secondary outcomes:
measure: Pregnancy Outcomes: Spontaneous abortion
timeFrame: Date of conception to 20 weeks gestation
measure: Pregnancy Outcomes: Stillbirth
timeFrame: After 20 weeks of gestation but prior to delivery
measure: Pregnancy Outcomes: Premature delivery
timeFrame: Live birth prior to 37 weeks gestation
measure: Infant Outcomes: pattern of minor structural birth defects
timeFrame: Up to 1 year of age of the infant
measure: Infant Outcomes: Small for gestational age
timeFrame: At birth
measure: Infant Outcomes: Postnatal growth deficiency
timeFrame: Up to 1 year of age of the infant
measure: Infant Outcomes: Serious or opportunistic infections
timeFrame: Up to 1 year of age of the infant
measure: Infant Outcomes: Hospitalizations
timeFrame: Up to 1 year of age of the infant
measure: Infant Outcomes: Malignancies
timeFrame: Up to 1 year of age of the infant -
Other outcomes:
Locations:
city: New York
country: United States
facility: United States
state: New York
city: Canada
country: Canada
facility: CANADA
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: