An Observational Study on Sarilumab-exposed Pregnancies

Evaluating Birth Defects in Pregnancies Exposed to Investigational Medication

Not Recruiting
Female
Phase N/A
113 participants needed

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
  • 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.

Updated on 25 Mar 2025. Study ID: NCT03378219

This study investigates the risk of major birth defects in pregnancies exposed to an investigational medication. The focus is on understanding if there is a higher risk of structural anomalies in babies born to mothers who have been exposed to this medication compared to those who have not. The study also looks at the outcomes for babies whose mothers have similar health conditions but are not exposed to the medication.

Participants in the study will be monitored throughout their pregnancy and for one year after giving birth. The study includes different study arms: one for those exposed to the investigational medication, one for those with the same health conditions but not exposed, and another for healthy pregnancies without exposure.

  • Who can participate: Pregnant women exposed to an investigational medication for an approved condition, those with similar health conditions but not exposed, and healthy pregnant women are eligible. Key exclusions include prior diagnosis of major defects or exposure to certain medications.
  • Study details: Participants will be observed throughout pregnancy and for one year post-delivery to assess the investigational medication's effects on pregnancy and infant outcomes. A placebo is not used.
  • Study timelines: The study will last for the duration of the pregnancy and one year after delivery.