Status:
COMPLETED
Safety of Exposure to Natalizumab During Pregnancy
Lead Sponsor:
University Hospital, Bordeaux
Collaborating Sponsors:
Biogen
Conditions:
Multiple Sclerosis
Eligibility:
FEMALE
18+ years
Brief Summary
Multiple sclerosis (MS) preferentially affects young adults with a female predominance. MS is not associated with an increased risk of complications or abnormal pregnancy outcomes. Nevertheless, disea...
Eligibility Criteria
Inclusion
- Age greater than 18 years at the index date (date of pregnancy onset) of data collection,
- RRMS according to McDonald's 2017 criteria (Thompson et al., 2018)
- Affiliated person or beneficiary of a social security scheme.
- followed up at one of the participating centers (OFSEP centers)
- NTZ exposure during pregnancy according to 3 pre-defined sub-groups: continuation of NTZ throughout pregnancy and postpartum (Group 1), exposure during the first trimester (Group 2) exposure during the first and the second trimester (Group 3).
- Participants capable of expressing non objection
- French-speaking, without comprehension disorders
Exclusion
- Patient concerned by articles L 1121-5 to L 1121-8 (persons deprived of their liberty by a judicial or administrative decision, minors, persons of legal age who are the object of a legal protection measure or unable to express their consent)
Key Trial Info
Start Date :
June 20 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 22 2023
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT05209815
Start Date
June 20 2022
End Date
December 22 2023
Last Update
January 16 2024
Active Locations (27)
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1
CHRU de Besançon - service de neurologie
Besançon, France
2
CHU de Bordeaux - service de neurologie
Bordeaux, France
3
HCL - service de neurologie
Bron, France
4
CH Sud Francilien - service de neurologie
Corbeil-Essonnes, France