Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| EUPAS106133 | Other Identifier | ENCePP |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study is an observational retrospective cohort study using longitudinal secondary data. Pregnant women with MS are assessed for exposure to Kesimpta and other MS disease modifying drugs (MSDMD) and followed up for adverse pregnancy and infant outcomes.
Outcomes among Kesimpta exposed pregnancies are compared primarily to MSDMD-exposed pregnancies and secondarily to MSDMD-unexposed pregnancies.
The main research question is to determine whether the exposure during pregnancy to Kesimpta increases the risk of adverse pregnancy and infant outcomes in women with MS.
The risk period is defined as the 1st trimester of pregnancy for analyses of Major congenital malformations and the entire duration of pregnancy for all other outcomes.
The data for this study is retrieved from data sources from Denmark, Sweden, and the US, based on an assessment of feasibility.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kesimpta-exposed | exposure to Kesimpta during the risk period |
| |
| MSDMD-exposed | exposure to at least one Multiple sclerosis disease modifying drug (MSDMD) (other than Kesimpta) during the risk period |
| |
| MSDMD-unexposed | no exposure to Kesimpta or any other Multiple sclerosis disease modifying drug (MSDMD) during the risk period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multiple sclerosis disease modifying drug | Other | There is no treatment allocation. Women with multiple sclerosis with a recorded pregnancy outcome during the inclusion period will be recruited. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of major congenital malformations (MCM) among live births | The primary outcome of interest concerns MCMs occurring in pregnancies ending in at least one live birth. MCMs are defined as defects that have either cosmetic or functional significance to the child (e.g., a cleft lip) | First year of life, up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with spontaneous abortions | Also termed miscarriage, is defined as the unintended loss of an intrauterine pregnancy less than 20 weeks of gestation (<20 weeks). | Up to 9 months |
| Number of participants with elective termination of pregnancy |
Not provided
Inclusion Criteria:
The following overall criteria for study inclusion are applied:
In addition, the following outcome and objective specific inclusion criteria are applied:
Exclusion Criteria:
The following overall criteria for exclusion are applied:
The following outcome specific exclusion criteria are applied:
Not provided
Not provided
The overall study population consists of women with MS with a recorded pregnancy outcome during the inclusion period. Pregnancies exposed to MSDMDs with a known teratogenic effect or non-MSDMDs with a known moderate to high teratogenic effect are excluded.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novartis Pharmaceuticals | Contact | +41613241111 | novartis.email@novartis.com | |
| Novartis Pharmaceuticals | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Recruiting | Basel | Switzerland |
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
Not provided
Not provided
Not provided
Defined as the intentional termination of pregnancy at any time in gestation for any reason. When possible, reasons for elective termination are captured and classified as elective termination of pregnancy for fetal anomaly or for other reasons. |
| Up to 9 months |
| Number of participants with stillbirths | Defined as the unintended fetal death occurring at or after 20 weeks of gestation. | Up to 9 months |
| Number of participants with preterm births | Defined as live births less than 37 weeks of gestation (<37 weeks). Elective caesarean deliveries or inductions prior to 37 completed weeks will be described separately. | Up to 9 months |
| Number of participants with preeclampsia | Preeclampsia is defined as the new-onset of hypertension with a systolic blood pressure greater than or equal to 140 mmHg and/or diastolic blood pressure greater than or equal to 90 mmHg at or after 20 weeks of gestation with proteinuria and/or endorgan dysfunction (renal dysfunction, liver dysfunction, central nervous system disturbances, pulmonary edema, and thrombocytopenia). | Up to 9 months |
| Number of participants with eclampsia | Eclampsia is defined as the new onset of generalized tonic-clonic seizures in a woman with preeclampsia | Up to 9 months |
| Number of participants small for gestational age (SGA) | Defined as a birth weight lower than the 10th percentile for gestational age and sex using the national standards in each study country in a live birth | Up to 9 months |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |