An Observational Study on Sarilumab-exposed Pregnancies

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2022
• Main ID: NCT03378219
• Date of registration: 15/12/2017
• Prospective Registration: Yes
• Primary sponsor: Sanofi
• Public title: An Observational Study on Sarilumab-exposed Pregnancies
• Scientific title: Kevzara® (Sarilumab) Pregnancy Exposure Registry: An OTIS Pregnancy Surveillance Study
• Date of first enrolment: May 18, 2018
• Target sample size: 113
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT03378219
• Study type: Observational

Countries of recruitment

Canada, United States

Contacts

• Name: Clinical Sciences & Operations
• Affiliation: Sanofi

Key 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.



Age minimum: N/A
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis -Exposure During Pregnancy

Intervention(s)

Drug: Sarilumab SAR153191 (REGN88)

Primary Outcome(s)

Rate of major structural birth defect [Time Frame: Up to 1 year of age of the infant]

Secondary Outcome(s)

Infant Outcomes: Postnatal growth deficiency [Time Frame: Up to 1 year of age of the infant]

Infant Outcomes: Serious or opportunistic infections [Time Frame: Up to 1 year of age of the infant]

Infant Outcomes: Hospitalizations [Time Frame: Up to 1 year of age of the infant]

Pregnancy Outcomes: Premature delivery [Time Frame: Live birth prior to 37 weeks gestation]

Infant Outcomes: Malignancies [Time Frame: Up to 1 year of age of the infant -]

Pregnancy Outcomes: Stillbirth [Time Frame: After 20 weeks of gestation but prior to delivery]

Infant Outcomes: pattern of minor structural birth defects [Time Frame: Up to 1 year of age of the infant]

Infant Outcomes: Small for gestational age [Time Frame: At birth]

Pregnancy Outcomes: Spontaneous abortion [Time Frame: Date of conception to 20 weeks gestation]

Secondary ID(s)

U1111-1200-1947

OBS15155

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Regeneron Pharmaceuticals