Rheumatoid Arthritis -Exposure During PregnancyNCT03378219
An Observational Study on Sarilumab-exposed Pregnancies
An observational study of Rheumatoid Arthritis -Exposure During Pregnancy, run by Sanofi at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis -Exposure During Pregnancy
- What is being tested?
- Sarilumab SAR153191 (REGN88)
- Type of treatment
- Injection or infusion
- How many people
- 113 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 18 May 2018to 6 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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 locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Kevzara® (Sarilumab) Pregnancy Exposure Registry: An OTIS Pregnancy Surveillance Study
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.
Read the 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.
- Being tested
- Sarilumab SAR153191 (REGN88)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sarilumab SAR153191 (REGN88)Drug
Also called Kevzara
Pharmaceutical form:injection Route of administration: subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 1 year of age of the infant
Secondary outcomes (9)
Pregnancy Outcomes: Spontaneous abortion
Spontaneous abortion is defined as non-deliberate embryonic or fetal death that occurs < 20.0 weeks' gestation post-LMP (Last Menstrual period).
Measured: Date of conception to 20 weeks gestation
Pregnancy Outcomes: Stillbirth
Stillbirth is defined as a non-deliberate fetal death that occurs at or after 20 weeks of gestation but prior to delivery.
Measured: After 20 weeks of gestation but prior to delivery
Pregnancy Outcomes: Premature delivery
Premature delivery is defined as live birth prior to 37 weeks' gestation as counted from LMP (Last Menstrual period).
Measured: Live birth prior to 37 weeks gestation
Infant Outcomes: pattern of minor structural birth defects
A specific pattern of 3 or more structural defects in live born infants with dysmorphological physical examination.
Measured: Up to 1 year of age of the infant
Infant Outcomes: Small for gestational age
Proportion of infants less than or equal to the 10th percentile for sex and gestational age on weight, length, or head circumference.
Measured: At birth
Infant Outcomes: Postnatal growth deficiency
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.
Measured: Up to 1 year of age of the infant
Infant Outcomes: Serious or opportunistic infections
Proportion of infants who experienced serious or opportunistic infections up to 1 year of age.
Measured: Up to 1 year of age of the infant
Infant Outcomes: Hospitalizations
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.
Measured: Up to 1 year of age of the infant
Infant Outcomes: Malignancies
Proportion of infants who reported malignancies reported in an infant after birth and up to 1 year of age.
Measured: Up to 1 year of age of the infant -
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2017
- Study start18 May 2018
- Primary completion6 Dec 2024
- Study completion6 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis -Exposure During PregnancyStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03378219
- Sponsor's protocol ID
- OBS15155
- Other IDs
- U1111-1200-1947
- Status last verified
- Jan 2025
- First submitted
- 15 Dec 2017
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kevzara® (Sarilumab) Pregnancy Exposure Registry: An OTIS Pregnancy Surveillance Study
- ClinicalTrials.gov ID
- NCT03378219
- Acronym / sponsor ID
- OBS15155
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- 18 May 2018 (actual)
- Primary completion
- 6 Dec 2024 (actual)
- Study completion
- 6 Dec 2024 (actual)
- First posted
- 19 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Drug: Sarilumab SAR153191 (REGN88)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 |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sarilumab SAR153191 (REGN88)Also: KevzaraPharmaceutical form:injection Route of administration: subcutaneous | Drug | Cohort 1 |
Primary outcome
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.
9 secondary outcomes
Pregnancy Outcomes: Spontaneous abortion
Time frame: Date of conception to 20 weeks gestation
Pregnancy Outcomes: Stillbirth
Time frame: After 20 weeks of gestation but prior to delivery
Pregnancy Outcomes: Premature delivery
Time frame: Live birth prior to 37 weeks gestation
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
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
Infant Outcomes: Malignancies
Time frame: Up to 1 year of age of the infant -
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis -Exposure During Pregnancy, run by Sanofi at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of major structural birth defect (time frame: Up to 1 year of age of the infant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2025; AzTrials last refreshed its copy on 31 Oct 2026.