Status:
COMPLETED
An Observational Study on Sarilumab-exposed Pregnancies
Lead Sponsor:
Sanofi
Collaborating Sponsors:
Regeneron Pharmaceuticals
Conditions:
Rheumatoid Arthritis -Exposure During Pregnancy
Eligibility:
FEMALE
Brief Summary
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 pregnan...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
May 18 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 6 2024
Estimated Enrollment :
113 Patients enrolled
Trial Details
Trial ID
NCT03378219
Start Date
May 18 2018
End Date
December 6 2024
Last Update
January 17 2025
Active Locations (2)
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1
United States
New York, New York, United States, 00000
2
CANADA
Canada, Canada