Rheumatoid Arthritis -Exposure During Pregnancy Clinical Trial
Official title:
Kevzara® (Sarilumab) Pregnancy Exposure Registry: An OTIS Pregnancy Surveillance Study
| Verified date | June 2024 |
| Source | Sanofi |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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 | Active, not recruiting |
| Enrollment | 113 |
| Est. completion date | October 18, 2024 |
| Est. primary completion date | October 18, 2024 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | N/A and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Canada | CANADA | Canada | |
| United States | United States | New York | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Sanofi | Regeneron Pharmaceuticals |
United States, Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | Up to 1 year of age of the infant | |
| Secondary | 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). | Date of conception to 20 weeks gestation | |
| Secondary | 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. | After 20 weeks of gestation but prior to delivery | |
| Secondary | Pregnancy Outcomes: Premature delivery | Premature delivery is defined as live birth prior to 37 weeks' gestation as counted from LMP (Last Menstrual period). | Live birth prior to 37 weeks gestation | |
| Secondary | 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. | Up to 1 year of age of the infant | |
| Secondary | 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. | At birth | |
| Secondary | 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. | Up to 1 year of age of the infant | |
| Secondary | Infant Outcomes: Serious or opportunistic infections | Proportion of infants who experienced serious or opportunistic infections up to 1 year of age. | Up to 1 year of age of the infant | |
| Secondary | 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. | Up to 1 year of age of the infant | |
| Secondary | Infant Outcomes: Malignancies | Proportion of infants who reported malignancies reported in an infant after birth and up to 1 year of age. | Up to 1 year of age of the infant - |