An Observational Study on Sarilumab-exposed Pregnancies

Brief description of study

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.

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.

Clinical Study Identifier: NCT03378219

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.

Last updated on 13 Jan 2022

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