This study is currently not recruiting participants.

An Observational Study on Sarilumab-exposed Pregnancies

Research Study on Sarilumab Exposure During Pregnancy

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.

This study investigates pregnancies exposed to sarilumab, focusing on understanding the condition in women who are pregnant. The purpose is to observe any major structural birth defects in these pregnancies compared to those without exposure to sarilumab.

The study evaluates the safety and effects of sarilumab exposure during pregnancy. It looks at various outcomes for the mother and infant, such as birth defects and other adverse effects, in a general manner.

  • Who can participate: Pregnant women currently exposed to sarilumab or with conditions approved for its use can participate. Comparison groups include those without such conditions or exposure.
  • Study details: This study does not involve any treatment, and no placebo is used.
Updated on 25 Mar 2025. Study ID: NCT03378219