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An Observational Study on Sarilumab-exposed Pregnancies

CompletedN/A

Sponsor: Sanofi

Conditions: Rheumatoid Arthritis -Exposure During Pregnancy

Interventions: Sarilumab SAR153191 (REGN88)

Countries: United States, Canada

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.

Eligibility overview

Sex: FEMALE

Healthy volunteers: Yes

Study type: OBSERVATIONAL

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.

Locations (2)

New York, New York, United States
Canada, Canada