An Observational Study on Sarilumab-exposed Pregnancies
Observational Study on Sarilumab Exposure During Pregnancy
Study Overview
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.
Study Details
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
You may be eligible for this study if you meet the following criteria:
- Conditions: Rheumatoid Arthritis -Exposure During Pregnancy
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Gender: Female
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.
This study investigates the effects of exposure to an investigational medication during pregnancy, specifically focusing on sarilumab. The purpose is to evaluate the risk of major structural birth defects and other adverse outcomes in pregnancies exposed to sarilumab compared to those that are not. Sarilumab is used for certain approved indications, and the study aims to understand the implications of its use during pregnancy.
Participants in this observational study will be monitored throughout their pregnancy and for one year after the birth of their child. The study will involve collecting data on birth outcomes and any potential birth defects or other health issues in the infants.
- Who can participate: Pregnant women exposed to sarilumab for an approved indication, those with a matching diagnosis but no exposure, and healthy pregnant women without diagnosis or exposure are eligible. Exclusions include prenatal diagnosis of major defects or exposure to other biologics or teratogens.
- Study details: Participants will be observed throughout their pregnancy and for one year after delivery. No experimental treatments or interventions will be administered, as the study is observational, focusing on pregnancy outcomes and infant health.
