Multiple SclerosisBABYZUMAB-2NCT05209815
Safety of Exposure to Natalizumab During Pregnancy
An observational study of Multiple Sclerosis, run by University Hospital, Bordeaux at 27 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 68 participants
- Where
- 27 sitesin 2 countries
- Study dates
- 20 Jun 2022to 22 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patient aged over 18 years old, affected by RRMS according to McDonald's 2017 criteria identified in the BABYZUMAB-1 study
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
27 sites in 2 countries.
27 sites in 2 countries
France26 sites
CHRU de Besançon - service de neurologie
Besançon
CHU de Bordeaux - service de neurologie
Bordeaux
HCL - service de neurologie
Bron
CH Sud Francilien - service de neurologie
Corbeil-Essonnes
AP-HP - Hôpital de Créteil - service de neurologie
Créteil
CHU de Dijon-Bourgogne
Dijon
CHU de Grenoble-Alpes
La Tronche
CHRU de Lille - service de neurologie
Lille
CHU de Limoges - service de neurologie
Limoges
AP-HM - service de neurologie
Marseille
CHU de Montpellier - service de neurologie
Montpellier
CHRU de Nancy - service de neurologie
Nancy
CHU de Nantes - service de neurologie
Nantes
CHU de Nice - service de neurologie
Nice
CHU de Nîmes - service de neurologie
Nîmes
AP-HP - Hôpital La Pitié Salpétrière - service de neurologie
Paris
AP-HP - Hôpital Saint-Antoine - service de neurologie
Paris
Fondation Rothschild - service de neurologie
Paris
CHU de Poitiers - service de neurologie
Poitiers
CHU de Rennes - service de neurologie
Rennes
CHU de Rouen - service de neurologie
Rouen
CH de Saint-Denis - service de neurologie
Saint-Denis
CHU d'Amiens - service de neurologie
Salouël
CHRU de Strasbourg - service de neurologie
Strasbourg
CHU de Toulouse - service de neurologie
Toulouse
CHU de Tours - service de neurologie
Tours
Martinique1 site
CHU de Fort de France - service de neurologie
Fort-de-France
About this study
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).
Read more
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
- Being tested
- Questionnaire
- Keywords
- Natalizumab, Safety, pregnancy
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
Questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | continuation of NTZ throughout pregnancy and postpartum Receives: Behavioral: Questionnaire | |
| Group 2 | exposure during the first trimester Receives: Behavioral: Questionnaire | |
| Group 3 | exposure during the first and the second trimester Receives: Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who presented serious adverse events (SAE) during their pregnancy
Measured: At baseline (Day 0)
Secondary outcomes (8)
Proportion of patients who presented pregnancy complications
Measured: At baseline (day 0)
Proportion of patients who presented delivery complications
Measured: At baseline (day 0)
Proportion of patients who presented postpartum AEs of interest
Measured: At baseline (day 0)
Proportion of viable children at birth
Measured: At baseline (day 0)
Average weight at birth
Measured: At baseline (day 0)
apgar score at birth
Measured: At baseline (day 0)
Number of child AEs of interest (haematological, infectious, malformations) at birth
Measured: At baseline (day 0)
Number of child AEs of interest (haematological, infectious, malformations) two years after birth
Measured: At baseline (day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start20 Jun 2022
- Primary completion22 Dec 2023
- Study completion22 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Biogen
- Responsible party
- Sponsor
- Investigators
- Aurélie RUET, Prof, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05209815
- Sponsor's protocol ID
- CHUBX 2020/65
- Acronym
- BABYZUMAB-2
- Status last verified
- Jan 2024
- First submitted
- 13 Jan 2022
- Last updated
- 16 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Exposure to Natalizumab During Pregnancy
- ClinicalTrials.gov ID
- NCT05209815
- Acronym / sponsor ID
- BABYZUMAB-2 / CHUBX 2020/65
- Conditions
- Multiple Sclerosis
- Keywords
- Natalizumab, Safety, pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Biogen
- Study start
- 20 Jun 2022 (actual)
- Primary completion
- 22 Dec 2023 (actual)
- Study completion
- 22 Dec 2023 (actual)
- First posted
- 27 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Behavioral: Questionnairecontinuation of NTZ throughout pregnancy and postpartum |
| Group 2 | – | Behavioral: Questionnaireexposure during the first trimester |
| Group 3 | – | Behavioral: Questionnaireexposure during the first and the second trimester |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient aged over 18 years old, affected by RRMS according to McDonald's 2017 criteria identified in the BABYZUMAB-1 study
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireQuestionnaire | Behavioural | Group 1, Group 2, Group 3 |
Primary outcome
Proportion of patients who presented serious adverse events (SAE) during their pregnancy
Time frame: At baseline (Day 0)
8 secondary outcomes
Proportion of patients who presented pregnancy complications
Time frame: At baseline (day 0)
Proportion of patients who presented delivery complications
Time frame: At baseline (day 0)
Proportion of patients who presented postpartum AEs of interest
Time frame: At baseline (day 0)
Proportion of viable children at birth
Time frame: At baseline (day 0)
Average weight at birth
Time frame: At baseline (day 0)
apgar score at birth
Time frame: At baseline (day 0)
Number of child AEs of interest (haematological, infectious, malformations) at birth
Time frame: At baseline (day 0)
Number of child AEs of interest (haematological, infectious, malformations) two years after birth
Time frame: At baseline (day 0)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aurélie RUET, Prof principal investigator
University Hospital, Bordeaux
27 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by University Hospital, Bordeaux at 27 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in France, Martinique. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who presented serious adverse events (SAE) during their pregnancy (time frame: At baseline (Day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2024.