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An Observational Study on Sarilumab-exposed Pregnancies

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ClinicalTrials.gov Identifier: NCT03378219
Recruitment Status : Recruiting
First Posted : December 19, 2017
Last Update Posted : October 14, 2021
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi

Tracking Information
First Submitted Date December 15, 2017
First Posted Date December 19, 2017
Last Update Posted Date October 14, 2021
Actual Study Start Date May 18, 2018
Estimated Primary Completion Date August 2027   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 15, 2017)
Rate of major structural birth defect [ Time Frame: Up to 1 year of age of the infant ]
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: December 15, 2017)
  • Pregnancy Outcomes: Spontaneous abortion [ Time Frame: Date of conception to 20 weeks gestation ]
    Spontaneous abortion is defined as non-deliberate embryonic or fetal death that occurs < 20.0 weeks' gestation post-LMP (Last Menstrual period).
  • Pregnancy Outcomes: Stillbirth [ Time Frame: After 20 weeks of gestation but prior to delivery ]
    Stillbirth is defined as a non-deliberate fetal death that occurs at or after 20 weeks of gestation but prior to delivery.
  • Pregnancy Outcomes: Premature delivery [ Time Frame: Live birth prior to 37 weeks gestation ]
    Premature delivery is defined as live birth prior to 37 weeks' gestation as counted from LMP (Last Menstrual period).
  • Infant Outcomes: pattern of minor structural birth defects [ Time Frame: Up to 1 year of age of the infant ]
    A specific pattern of 3 or more structural defects in live born infants with dysmorphological physical examination.
  • Infant Outcomes: Small for gestational age [ Time Frame: At birth ]
    Proportion of infants less than or equal to the 10th percentile for sex and gestational age on weight, length, or head circumference.
  • Infant Outcomes: Postnatal growth deficiency [ Time Frame: Up to 1 year of age of the infant ]
    Proportion of infants less than or equal to the 10th percentile for sex and age on weight, length, or head circumference at 1 year postnatal evaluation.
  • Infant Outcomes: Serious or opportunistic infections [ Time Frame: Up to 1 year of age of the infant ]
    Proportion of infants who experienced serious or opportunistic infections up to 1 year of age.
  • Infant Outcomes: Hospitalizations [ Time Frame: Up to 1 year of age of the infant ]
    Proportion of infants who experienced hospitalizations in the first year of life excluding those that are linked to premature delivery or birth defects included as endpoints.
  • Infant Outcomes: Malignancies [ Time Frame: Up to 1 year of age of the infant - ]
    Proportion of infants who reported malignancies reported in an infant after birth and up to 1 year of age.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title An Observational Study on Sarilumab-exposed Pregnancies
Official Title Kevzara® (Sarilumab) Pregnancy Exposure Registry: An OTIS Pregnancy Surveillance Study
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.

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 that infant.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Rheumatoid Arthritis -Exposure During Pregnancy
Intervention Drug: Sarilumab SAR153191 (REGN88)
Pharmaceutical form:injection Route of administration: subcutaneous
Other Name: Kevzara
Study Groups/Cohorts
  • 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
    Intervention: 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 15, 2017)
300
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 2027
Estimated Primary Completion Date August 2027   (Final data collection date for primary outcome measure)
Eligibility 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.

Sex/Gender
Sexes Eligible for Study: Female
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts
Contact: Trial Transparency email recommended (Toll free number for US & Canada) 800-633-1610 ext 1 then # Contact-US@sanofi.com
Listed Location Countries Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03378219
Other Study ID Numbers OBS15155
U1111-1200-1947 ( Other Identifier: UTN )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Sanofi
Study Sponsor Sanofi
Collaborators Regeneron Pharmaceuticals
Investigators
Study Director: Clinical Sciences & Operations Sanofi
PRS Account Sanofi
Verification Date October 2021