Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will utilize a prospective, observational, exposure cohort design to examine pregnancy and infant outcomes in women and infants who are exposed to siponimod during pregnancy to treat MS.
The prevalence of each outcome in women exposed to siponimod and their infants will be compared to those observed in two unexposed comparator groups: a disease-matched comparison group of women who have not used siponimod during pregnancy but have been diagnosed with MS (disease-matched unexposed comparison group), and a comparison group of healthy women who do not have diagnosis of MS, have not had exposure to a known human teratogen, and have not taken siponimod in pregnancy (healthy comparison group). Pregnant women exposed to siponimod who do not meet the prospective cohort criteria will also be followed as part of an exposure series. All participants will be recruited via voluntary participant registration following informed consent by the pregnant woman for her participation. Participants may withdraw from the study at any time.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Siponimod-Exposed | Pregnant women with MS exposed to siponimod during pregnancy |
| |
| Disease-Matched Comparison | Pregnant women with MS not exposed to siponimod during pregnancy | ||
| Healthy Comparison | Pregnant women who are neither diagnosed with MS nor with any other autoimmune disease, and not exposed to siponimod or any known teratogenic agent during pregnancy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Siponimod | Other | Prospective observational cohort study. There is no treatment allocation. Patients administered siponimod, that have started before inclusion of the patient into the study will be enrolled. |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of major structural defects | A major structural defect is defined as a defect that has either cosmetic or functional significance to the child (e.g., a cleft lip). | Up to 10,5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of spontaneous abortion/miscarriage | Spontaneous abortion/miscarriage is defined as non-deliberate fetal death which occurs prior to less than 20.0 weeks post-LMP. | Up to 10,5 years |
| Number of stillbirth |
Not provided
Inclusion Criteria:
Participants must meet all the criteria listed under the respective cohorts to enroll in that particular cohort of the registry:
Cohort 1: Siponimod-Exposed Cohort
Cohort 2: Disease-Matched Comparison Cohort (Comparison Group 1)
Cohort 3: Healthy Comparison Cohort (Comparison Group 2):
Exclusion Criteria:
Women meeting any of the following criteria will be excluded from the cohort study:
Cohort 1: Siponimod-Exposed Cohort
Women who have enrolled in the siponimod cohort study with a previous pregnancy
Women who have used siponimod for an indication other than a currently approved indication
Women with exposure to any of the following medications within 5 half-lives prior to conception:
Retrospective enrollment after the outcome of pregnancy is known (i.e. the pregnancy has ended prior to enrollment)
Results of a diagnostic test are positive for a major structural defect prior to enrollment. However, women who have had any normal or abnormal prenatal screening or diagnostic test prior to enrollment are eligible as long as the test result does not indicate a major structural defect.
Cohort 2: Disease-Matched Comparison Cohort (Comparison Group 1):
Exposure to siponimod any time from the 4th day post the first day of LMP prior to conception up to and including end of pregnancy
Women with exposure to any of the following medications within 5 half-lives of conception:
Women who have enrolled in the siponimod cohort or OMB157G2403 Kesimpta cohort with a previous pregnancy
Retrospective enrollment after the outcome of pregnancy is known (i.e. the pregnancy has ended prior to enrollment)
Results of a diagnostic test are positive for a major structural defect prior to enrollment. However, women who have had any normal or abnormal prenatal screening or diagnostic test prior to enrollment are eligible as long as the test result does not indicate a major structural defect.
Cohort 3: Healthy Comparison Cohort (Comparison Group 2):
The study population includes pregnant women.
Not provided
Not provided
The study population includes pregnant women who reside in the US or Canada.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novartis Pharmaceuticals | Contact | 1-888-669-6682 | novartis.email@novartis.com | |
| Diana Johnson | Contact | 1-877-311-8972 | mothertobaby@health.ucsd.edu |
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Recruiting | La Jolla | California | 92093-0934 | United States |
Not provided
| Label | URL |
|---|---|
| MotherToBaby Pregnancy Studies are observational studies coordinated at the University of California San Diego. Our studies are currently enrolling pregnant women in a study examining the use of medications to treat multiple sclerosis during pregnancy. | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C578989 | siponimod |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
stillbirth is defined as non-deliberate fetal death anytime in gestation at or after 20 weeks post-LMP.
| Up to 10,5 years |
| Number of elective termination | elective termination/abortion is defined as deliberate termination of pregnancy at any time in gestation. Reasons for elective abortions are captured and are classified as due to medical reasons or social reasons. | Up to 10,5 years |
| Number of premature delivery | premature delivery is defined as live birth prior to 37.0 weeks gestation as counted from LMP (or calculated from first-trimester ultrasound-derived due date if last menstrual period uncertain or more than 1 week discrepant). Elective caesarian deliveries or inductions prior to 37.0 completed weeks will be considered separately. | Up to 10,5 years |
| Number of preeclampsia / eclampsia | preeclampsia or eclampsia reported by maternal interview with confirmation in medical record or report by medical record only is captured. Preeclampsia is defined as a new onset of hypertension and proteinuria during pregnancy or postpartum. Eclampsia is the new onset of seizures or coma in a pregnant woman with preeclampsia. These seizures are not related to an existing brain condition. | Up to 1 10,5 years |
| Pattern of 3 or more minor structural defects | A minor structural defect is defined as a defect which has neither cosmetic nor functional significance to the child (e.g., complete 2,3 syndactyly of the toes). Minor structural defects will be identified only through the study dysmorphology examination for live born infants using the study-specific checklist. | Up to 10,5 years |
| Small for gestational age | small for gestational age is defined as birth size (weight, length or head circumference) less than or equal to the 10th centile for sex and gestational age using standard pediatric CDC growth curves for full term or preterm infants (CDC, 2000; Olsen et al., 2010). | Up to 10,5 years |
| Postnatal growth small for age at approximately one year of age | postnatal growth deficiency is defined as postnatal size (weight, length or head circumference) less than or equal to the 10th centile for sex and age using National Center for Health Statistics (NCHS) pediatric growth curves, and adjusted postnatal age for premature infants if the postnatal measurement is obtained at less than one year of age (CDC, 2000). | Up to 10,5 years |
| Developmental performance at approximately one year of age | Screening of Developmental Milestones: one or more domains scored as abnormal on the Ages and Stages Questionnaire completed by the mother when the infant is approximately one year of age will define achievement of developmental milestones. | Up to 10,5 years |
| Serious or opportunistic infections in the first year of life | serious or opportunistic infections are defined as any one or more diagnoses of tuberculosis, x-ray proven pneumonia, neonatal sepsis, meningitis, bacteremia, invasive fungal infection, pneumocysitis, septic arthritis, osteomyelitis, abcess (deep tissue), and infections requiring hospitalization identified in live born infants up to one year of age. | Up to 10,5 years |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |