Safety of Exposure to Natalizumab During Pregnancy

NCT ID: NCT05209815

Last Updated: 2024-01-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 68 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-06-20
• Study Completion Date: 2023-12-22

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, disease-modifying therapies can have a teratogenic effect. Discussions about discontinuation should be made with a view to or upon discovery of pregnancy, taking into account the risk of untreated relapses and the risk of toxicity to the fetus.

Natalizumab (NTZ) is a humanized anti-alpha4-integrin monoclonal antibody used as a treatment for highly active relapsing-remitting MS (RRMS). When it is stopped, there is frequent reactivation of the disease with possible relapses and a rebound effect could occur. At present, depending on the center, attitudes of neurologist may vary and 3 main scenarios can be observed: Pregnancy and postpartum under NTZ (group1), Pregnancy partially under NTZ (with or without immunomodulator (IM) supplementation, group 2), or NTZ stopped before pregnancy (with or without IM supplementation, group3).

The first part of the BABYZUMAB study, a retrospective study of Natalizumab exposure during pregnancy, analysed the comparison the clinical activity of the disease (annualized relapse rate) according to these 3 scenarios of NTZ treatment The investigators analyzed the annual relapse rate (ARR) during a two-year period (9 months before and 15 months after the beginning of the pregnancy) in 117 patients identified in the OFSEP database. The investigators showed that the risk of relapses was four times higher in Group 2 versus Group 1 (p=0,014) and six times higher in Group 3 versus Group 1 (p=0,001).

In the literature, there are few studies of newborns from NTZ-exposed pregnancies. No specific pattern of birth defects has been found, but mild to moderate transient thrombocytopenia and anemia have been reported in infants born to NTZ-exposed mothers in the third trimester of pregnancy.

Conditions

Multiple Sclerosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group 1

continuation of NTZ throughout pregnancy and postpartum

Questionnaire

Intervention Type: BEHAVIORAL

Questionnaire

Group 2

exposure during the first trimester

Questionnaire

Intervention Type: BEHAVIORAL

Questionnaire

Group 3

exposure during the first and the second trimester

Questionnaire

Intervention Type: BEHAVIORAL

Questionnaire

Interventions

Questionnaire

Questionnaire

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Biogen

INDUSTRY

Sponsor Role: collaborator

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aurélie RUET, Prof

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Locations

CHRU de Besançon - service de neurologie

Besançon, , France

CHU de Bordeaux - service de neurologie

Bordeaux, , France

HCL - service de neurologie

Bron, , France

CH Sud Francilien - service de neurologie

Corbeil-Essonnes, , France

AP-HP - Hôpital de Créteil - service de neurologie

Créteil, , France

CHU de Dijon-Bourgogne

Dijon, , France

CHU de Grenoble-Alpes

La Tronche, , France

CHRU de Lille - service de neurologie

Lille, , France

CHU de Limoges - service de neurologie

Limoges, , France

AP-HM - service de neurologie

Marseille, , France

CHU de Montpellier - service de neurologie

Montpellier, , France

CHRU de Nancy - service de neurologie

Nancy, , France

CHU de Nantes - service de neurologie

Nantes, , France

CHU de Nice - service de neurologie

Nice, , France

CHU de Nîmes - service de neurologie

Nîmes, , France

AP-HP - Hôpital La Pitié Salpétrière - service de neurologie

Paris, , France

AP-HP - Hôpital Saint-Antoine - service de neurologie

Paris, , France

Fondation Rothschild - service de neurologie

Paris, , France

CHU de Poitiers - service de neurologie

Poitiers, , France

CHU de Rennes - service de neurologie

Rennes, , France

CHU de Rouen - service de neurologie

Rouen, , France

CH de Saint-Denis - service de neurologie

Saint-Denis, , France

CHU d'Amiens - service de neurologie

Salouël, , France

CHRU de Strasbourg - service de neurologie

Strasbourg, , France

CHU de Toulouse - service de neurologie

Toulouse, , France

CHU de Tours - service de neurologie

Tours, , France

CHU de Fort de France - service de neurologie

Fort-de-France, , Martinique

Countries

France; Martinique

Other Identifiers

CHUBX 2020/65

Identifier Type: -

Identifier Source: org_study_id