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An Observational Study on Sarilumab-exposed Pregnancies

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages N/A and Over
Gender Female
More Inclusion & Exclusion Criteria

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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT03378219
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Sanofi
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Clinical Sciences & Operations
Principal Investigator Affiliation Sanofi
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Recruiting
Countries Canada, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Rheumatoid Arthritis -Exposure During Pregnancy
Additional Details

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.

Arms & Interventions

Arms

: 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

: 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

Drug: - Sarilumab SAR153191 (REGN88)

Pharmaceutical form:injection Route of administration: subcutaneous

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

United States, New York, New York

Status

Recruiting

Address

United States

New York, New York, 00000

International Sites

CANADA, Canada, Canada

Status

Recruiting

Address

CANADA

Canada, ,

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