An Observational Study on Sarilumab-exposed Pregnancies

NCT03378219 | Completed DMC FDA Drug

• 2 other identifiers: OBS15155U1111-1200-1947
• Study Type: observational
• Target: 113
• Locations: 2 countries
• Sites: 2

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 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.

Conditions

Rheumatoid Arthritis -Exposure During Pregnancy

Outcome Measures

Primary Outcomes (1)

• Rate of major structural birth defect

  A major structural birth defect is a defect that has either cosmetic or functional significance to the child (eg, a cleft lip) and is identified up to one year of age by the mother, the health care provider/medical record, or identified in the dysmorphological examination.

  Up to 1 year of age of the infant

Secondary Outcomes (9)

• Pregnancy Outcomes: Spontaneous abortion

  Date of conception to 20 weeks gestation

• Pregnancy Outcomes: Stillbirth

  After 20 weeks of gestation but prior to delivery

• Pregnancy Outcomes: Premature delivery

  Live birth prior to 37 weeks gestation

• Infant Outcomes: pattern of minor structural birth defects

  Up to 1 year of age of the infant

• Infant Outcomes: Small for gestational age

  At birth

Study Arms (3)

Cohort 1

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

Drug: Sarilumab SAR153191 (REGN88)

Cohort 2

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

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

Interventions

Sarilumab SAR153191 (REGN88) DRUG

Pharmaceutical form:injection Route of administration: subcutaneous

Also known as: Kevzara

Cohort 1

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (2)

United States

New York, New York, 00000, United States

Location

CANADA

Canada, Canada

Location

MeSH Terms

Interventions

sarilumab

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2017
• First Posted: December 19, 2017
• Study Start: May 18, 2018
• Primary Completion: December 6, 2024
• Study Completion: December 6, 2024
• Last Updated: January 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); CA (1)