Actively Recruiting
Kesimpta Pregnancy and Infant Safety Study Using Real World Data
Led by Novartis Pharmaceuticals · Updated on 2024-08-01
1500
Participants Needed
1
Research Sites
187 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Kesimpta Pregnancy and Infant Safety Study Using Real World Data
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnancy with a recorded start and end of pregnancy outcome (live birth, spontaneous abortion, elective termination, stillbirth, or ectopic pregnancy) during the inclusion period
- Age 18-49 years at index date
- Diagnosis of Multiple Sclerosis before the index date
- Availability of information on exposure to MS disease modifying drugs and maternal baseline characteristics for at least 12 months before the index date
- For analyses of major congenital malformations: pregnancy ending in at least one live birth
- For analyses of spontaneous abortion, elective termination, stillbirth, preeclampsia, eclampsia: pregnancy ending in at least one live birth, spontaneous abortion, elective termination, stillbirth, or ectopic pregnancy
- For analyses of preterm birth, small for gestational age: pregnancy ending in at least one live birth
- For exploratory analyses of major congenital malformations: pregnancy ending in at least one live birth, spontaneous abortion, stillbirth, or elective termination
- For analyses of neonatal infection: live newborn
- For analyses of serious infant infections: newborn alive at 29 days after birth
You will not qualify if you...
- Pregnancy exposed to MS disease modifying drugs known to cause birth defects
- Pregnancy exposed to non-MS drugs known to have moderate to high birth defect risk
- For analyses of major congenital malformations: pregnancies with chromosomal abnormalities or genetic syndromes
- For analyses of preterm birth, preeclampsia, eclampsia, and small for gestational age: pregnancies with multiples (twins or more)
- For Kesimpta and MS disease modifying drug-exposed groups: pregnancies not exposed during the specific risk period for each outcome
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Novartis Investigative Site
Basel, Switzerland
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
CONTACT
N
Novartis Pharmaceuticals
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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