An Observational Study on Sarilumab-exposed Pregnancies

STATUS

Recruiting
End date

Aug 12, 2027
participants needed

300
sponsor

Sanofi

Updated on 19 February 2024

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Summary

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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.

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 that infant.

Details

Condition	Rheumatoid Arthritis -Exposure During Pregnancy
Age	100years or below
Treatment	Sarilumab SAR153191 (REGN88)
Clinical Study Identifier	NCT03378219
Sponsor	Sanofi
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
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

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Step 2 Get screened

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Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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An Observational Study on Sarilumab-exposed Pregnancies