An Observational Study on Sarilumab-exposed Pregnancies

Sanofi

Status: Completed

Conditions: Rheumatoid Arthritis -Exposure During Pregnancy

Treatments: Drug: Sarilumab SAR153191 (REGN88)

Study type: Observational

Funder types: Industry

Identifiers

NCT03378219

OBS15155

U1111-1200-1947 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 113 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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.

Trial design

113 participants in 3 patient groups

Cohort 1

Description:

Sarilumab-Exposed Cohort: Pregnant women exposed to Kevzara (sarilumab) for the treatment of an approved Kevzara (sarilumab) indication, for any number of days, at any dose, and at any time from the first day of the last menstrual period (LMP) up to and including the end of pregnancy

Treatment:

Drug: Sarilumab SAR153191 (REGN88)

Cohort 2

Description:

Disease-matched Comparison Cohort: Pregnant women diagnosed with Kevzara (sarilumab) approved indication. Approximate frequency matched to the exposed group by disease indication, validated by medical records, who have not been exposed to Kevzara (sarilumab) any time in the current pregnancy, and have taken another biologic DMARD medication for their disease within 2 years before the current pregnancy and have an indication for such treatment at enrollment

Cohort 3

Description:

Non-diseased Comparison Cohort: Healthy pregnant women not diagnosed with a Kevzara (sarilumab) indication and unexposed to Kevzara (sarilumab) during the course of the pregnancy