NCT03378219Completed
An Observational Study on Sarilumab-exposed Pregnancies
Kevzara® (Sarilumab) Pregnancy Exposure Registry: An OTIS Pregnancy Surveillance Study
Source: ClinicalTrials.gov · Last updated 17 Jan 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 113 (actual)
- First submitted
- 15 Dec 2017
- Start date
- 18 May 2018
- Primary completion date
- 6 Dec 2024
- Lead sponsor
- Sanofi
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT03378219
What you commit to
- Study type: Observational
- Participants enrolled: 113
- From 18 May 2018 to the primary completion date, 6 Dec 2024
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Enrolled in this cohort study with a previous pregnancy. Cohort 1: Sarilumab-Exposed Cohort
- 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.
- 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.
Other illness
- Cohort 2: Disease-matched Comparison Cohort
- Diagnosed for any serious chronic disease that is thought to adversely impact pregnancy.
Other
- First contact the Registry after prenatal diagnosis of any major structural defect or after pregnancy outcome is known (retrospective data).
- Exposed to Kevzara (sarilumab) for an indication other than a currently approved indication.
- Cohort 3: Non-diseased Comparison Cohort
- 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.
Who the study is looking for
- 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
Sex: Female · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CANADA Coordinator of this site? Confirm its status | Canada | Canada | Unknown status |
| United States Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.