Sclerosis, MultipleRESPONSENCT03900221
French Registry for Monitoring Pregnancies for Multiple Sclerosis
An observational study of Sclerosis, Multiple and Neuromyelitis Optica Spectrum Disorder, run by Hospices Civils de Lyon at 48 sites in 2 countries.
Trial summary
The influence of pregnancy on the course of multiple sclerosis (MS) has long been a controversial topic. After the publication of the first large prospective study of pregnancy and MS in 1998, counselling of women with MS has radically changed and many patients have been able to fulfill their desire of motherhood. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sclerosis, Multiple, Neuromyelitis Optica Spectrum Disorder, Myelin Oligodendrocyte Glycoprotein (MOG)-Antibody Related Disorders
- How many people
- 1,500 participants
- Where
- 48 sitesin 2 countries
- Study dates
- 12 Aug 2019to 12 Aug 2036
- How long will I take part?
- 7 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Pregnant women with multiple sclerosis or related neurological syndromes
Who may be able to join
- All groups of patients eligible to participate to the Observatoire Français de la Sclérose en Plaque (OFSEP), including :
- Definite Multiple sclerosis (MS) according to McDonald criteria
- Whatever the clinical course (single attack MS, relapsing-remitting MS, secondary progressive MS, primary progressive MS)
- Radiologically Isolated Syndromes (RIS) (will be validated by the RIS expert group)
- Clinically Isolated Syndromes (CIS)
- Neuromyelitis optica (NMO) and NMO spectrum disorders (will be validated by the "Neuro-optico-myélite aiguë de Devic et des syndromes neurologiques apparentés" (NOMADMUS) expert group)
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- No age limit (patients under the age of 18 might be included, provided informed consent is obtained from the parents)
- Ongoing pregnancy: there will be no limit in the gestational age at inclusion. Women can be included at any time before delivery, but the gestational age at inclusion will be recorded and introduced in the analyses whenever pertinent. However, neurologists and patients will be encouraged to start the study as soon as pregnancy is diagnosed.
- Able to give informed consent
- Able to read and/or understand French
Who cannot join
- None
Trial locations and contacts
48 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
48 sites in 2 countries
France47 sites, 47 recruiting
- Recruiting
Chu D'Amiens
Amiens, 80054
Abdullatif AL KHEDR
Abdullatif AL KHEDR
- Recruiting
Centre Hospitalier Annecy Genevois
Annecy, 74000
Nathalie MOREL
Nathalie MOREL
- Recruiting
Centre Hospitalier d'Avignon
Avignon, 84000
Patricia TOURNAIRE
Patricia TOURNAIRE
- Recruiting
Hopital Jean Minjoz
Besançon, 25030
Eric BERGER
Eric BERGER
- Recruiting
Hopital Pellegrin
Bordeaux, 33076
Aurélie RUET
Aurélie RUET
- Recruiting
Hôpital de Brive
Brive-la-Gaillarde, 19100
Alexis MONTCUQUET
Alexis MONTCUQUET
- Recruiting
Hôpital Neurologique Pierre Wertheimer
Bron, 69677
Sandra VUKUSIC, 4 72 68 13 13 ext. +33, sandra.vukusic@chu-lyon.fr
Sandra VUKUSIC
- Recruiting
Hopital Cote de Nacre
Caen, 14033
Pierre BRANGER
Pierre BRANGER
- Recruiting
Centre hospitalier Métropole Savoie
Chambéry, 73000
Clara GROSSET-JANIN
Clara GROSSET-JANIN
- Recruiting
Hopital Gabriel Montpied
Clermont-Ferrand, 63003
Pierre CLAVELOU
Pierre CLAVELOU
- Recruiting
Hopital Henri Mondor
Créteil, 94010
Alain CREANGE
Alain CREANGE
- Recruiting
Hopital Du Bocage
Dijon, 21079
Thibault MOREAU
Thibault MOREAU
- Recruiting
Ch Epinal
Épinal, 88000
Evelyne PLANQUE
Evelyne PLANQUE
- Recruiting
Hôpital Raymond Poincaré
Garches, 92380
Ayman TOURBAH
Ayman TOURBAH
- Recruiting
Centre hospitalier Joséphine Baker Gonesse
Gonesse, 95500
Eric MANCHON
Eric MANCHON
- Recruiting
Chu de Grenoble
Grenoble, 38043
Olivier CASEZ
Olivier CASEZ
- Recruiting
Centre Hospitalier de Versailles Hôpital Andre Mignot
Le Chesnay, 78157
Chantal NIEFLE
Chantal NIEFLE
- Recruiting
Hôpital St Vincent De Paul
Lille, 59020
Arnaud KWIATKOWSKI
Arnaud KWIATKOWSKI
- Recruiting
Chru de Lille
Lille, 59037
Hélène ZEPHIR
Hélène ZEPHIR
- Recruiting
Hopital Dupuytren
Limoges, 87042
Laurent MAGY
Laurent MAGY
- Recruiting
Cabinet médical Dr Philippe NEUSCHWANDER
Lyon, 69006
Philippe NEUSCHWANDER
Philippe NEUSCHWANDER
- Recruiting
Centre Hospitalier Saint Joseph Saint Luc
Lyon, 69007
Amandine BENOIT
Amandine BENOIT
- Recruiting
Cabinet médical Dr C. CORNUT-CHAUVINC
Lyon, 69008
Catherine CORNUT- CHAUVINC
Catherine CORNUT- CHAUVINC
- Recruiting
Hopital Timone Adultes
Marseille, 13385
Jean PELLETIER
Jean PELLETIER
- Recruiting
Hopital Gui de Chauliac
Montpellier, 34295
Pierre LABAUGE
Pierre LABAUGE
- Recruiting
Cabinet médical Dr L. GUILLOTON
Mornant, 69440
Laurent GUILLOTON
Laurent GUILLOTON
- Recruiting
Hôpital Central
Nancy, 54035
Guillaume MATHEY
Guillaume MATHEY
- Recruiting
Hopital Pasteur
Nice, 06001
Christine LEBRUN-FRENAY
Christine LEBRUN-FRENAY
- Recruiting
Hopital Caremeau
Nîmes, 30029
Eric THOUVENOT
Eric THOUVENOT
- Recruiting
Hôpital Paris Saint Joseph
Paris, 75014
Hélène BRASME
Hélène BRASME
- Recruiting
Fondation Rotschild
Paris, 75019
Caroline BENSA-KOSCHER
Caroline BENSA-KOSCHER
- Recruiting
Hôpital national des Quinze-Vingt.
Paris, 75571
Dalia DIMITRI BOULOS
Dalia DIMITRI BOULOS
- Recruiting
Hopital Pitie Salpetriere
Paris, 75651
Elisabeth MAILLART
Elisabeth MAILLART
- Recruiting
Chi Poissy Saint Germain En Laye
Poissy, 78303
Olivier HEINZLEF
Olivier HEINZLEF
- Recruiting
Chr La Miletrie
Poitiers, 86021
Amélie DOS SANTO
Jean-Philippe NEAU
- Recruiting
Hopital Rene Dubos
Pontoise, 95300
Corinne DUPEL-POTTIER
Corinne DUPEL-POTTIER
- Recruiting
Hopital Pontchaillou
Rennes, 35033
Laure MICHEL
Laure MICHEL
- Recruiting
Hôpital Charles-Nicolle
Rouen, 76000
Bertrand BOURRE
Bertrand BOURRE
- Recruiting
Centre Hospitalier de Saint-Denis
Saint-Denis, 93200
Thomas DEBROUCKER
Thomas DEBROUCKER
- Recruiting
Hopital G. Et R. Laennec
Saint-Herblain, 44800
David LAPLAUD
David LAPLAUD
- Recruiting
Centre Hospitalier Mémorial
Saint-Lô, 50009
Lydie DUBUC-LEPETIT
Lydie DUBUC-LEPETIT
- Recruiting
Hopital Nord
Saint-Priest-en-Jarez, 42277
Jean-Philippe CAMDESSANCHE
Jean-Philippe CAMDESSANCHE
- Recruiting
Hopital Hautepierre
Strasbourg, 67098
Jérôme DE SEZE
Jérôme DE SEZE
- Recruiting
Hôpital Foch
Suresnes, 92151
Maya TCHIKVILADZE
Maya TCHIKVILADZE
- Recruiting
Hopital Purpan
Toulouse, 31059
Jonathan CIRON
Jonathan CIRON
- Recruiting
Chru de Tours Hopital Bretonneau
Tours, 37044
Ines DOGHRI
Ines DOGHRI
- Recruiting
Médipôle Lyon Villeurbanne
Villeurbanne, 69100
Pékès CODJA
Pékès CODJA
Martinique1 site, 1 recruiting
- Recruiting
Hopital P. Zobda-Quitman
Fort-de-France, 97200
Thomas DAVID
Thomas DAVID
About this study
Official title: French Registry for Monitoring Pregnancies and Children of Women With Multiple Sclerosis Within The Observatoire Français de la Sclérose en Plaque (OFSEP) Cohort
The influence of pregnancy on the course of multiple sclerosis (MS) has long been a controversial topic. After the publication of the first large prospective study of pregnancy and MS in 1998, counselling of women with MS has radically changed and many patients have been able to fulfill their desire of motherhood. However, there are still some challenges for the neurologist, who has to face old unanswered questions or new issues, regarding the use of disease modifying drugs (DMDs) in this period of life, effects on the short and long term outcome of the mother (in terms of relapses and disability) and the child, role of breast-feeding and locoregional analgesia.
To set up a national prospective pregnancy registry for patients with MS, nested within the Observatoire Français de la Sclérose en Plaque (OFSEP) cohort, owing to a better knowledge of interactions between MS and pregnancy-related issues (pregnancy itself, locoregional analgesia, breastfeeding, impact of using or stopping DMDs on women/children…)
Read the detailed description
METHODOLOGY Prospective, observational, multicentric and national epidemiological study, within the scope of the OFSEP, including all groups of patients eligible to participate in the Observatoire Français de la Sclérose en Plaque (OFSEP) (definite MS, radiologically isolated syndromes, clinically isolated syndromes, neuromyelitis optica (NMO) and NMO spectrum disorders), with no age limit and an ongoing pregnancy. Women will be followed during pregnancy and in the year after and their children until 6 years of age.
STATISTICAL ANALYSIS To be determined for each specific question. EXPECTED RESULTS Interactions between pregnancy and MS course have been well characterized before the therapeutic era. Neurologists and patients are lacking information to weigh benefits and risks of DMDs used immediately before or during pregnancy, including short and long-term risks to the mother and to the child, but also after delivery. This study should help provide better answers to those questions as well as to still controversial questions about locoregional analgesia and breastfeeding. By following these patients within the Observatoire Français de la Sclérose en Plaque (OFSEP) cohort, the investigator will also have access to a comprehensive description of MS before pregnancy but also in the long term.
- Conditions
- Sclerosis, Multiple, Neuromyelitis Optica Spectrum Disorder, Myelin Oligodendrocyte Glycoprotein (MOG)-Antibody Related Disorders, Pregnancy Abnormal
- Being tested
- No intervention
- Keywords
- Multiple sclerosis, pregnancy, disease modifying drugs, breastfeeding, loco-regional analgesia
- Medical subject headings
- Multiple Sclerosis, Neuromyelitis Optica, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women with multiple sclerosis or related neurological | Children born to women with multiple sclerosis or related neurological syndromes. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 during pregnancy period
Description of the current neurological practice of French neurologists regarding disease modifying drugs and desire of pregnancy and evaluation of its short term impact on the risk of relapses.
Measured: up to 2 years
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 during post-partum period
Description of the current neurological practice of French neurologists regarding disease modifying drugs and desire of pregnancy and evaluation of its short term impact on the risk of relapses.
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study start12 Aug 2019
- Primary completion12 Aug 2036 (estimated)
- Study completion12 Aug 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sclerosis, MultipleStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- 1,500 participants (estimated)
- Target duration
- 7 Years
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sandra VUKUSIC, Prof., Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03900221
- Sponsor's protocol ID
- 69HCL18_0631
- Other IDs
- 2018-A02552-53
- Acronym
- RESPONSE
- Status last verified
- Dec 2025
- First submitted
- 8 Mar 2019
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- French Registry for Monitoring Pregnancies and Children of Women With Multiple Sclerosis Within The Observatoire Français de la Sclérose en Plaque (OFSEP) Cohort
- ClinicalTrials.gov ID
- NCT03900221
- Acronym / sponsor ID
- RESPONSE / 69HCL18_0631
- Conditions
- Sclerosis, Multiple, Neuromyelitis Optica Spectrum Disorder, Myelin Oligodendrocyte Glycoprotein (MOG)-Antibody Related Disorders, Pregnancy Abnormal
- Keywords
- Multiple sclerosis, pregnancy, disease modifying drugs, breastfeeding, loco-regional analgesia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 12 Aug 2019 (actual)
- Primary completion
- 12 Aug 2036 (estimated)
- Study completion
- 12 Aug 2036 (estimated)
- First posted
- 2 Apr 2019 (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.
The influence of pregnancy on the course of multiple sclerosis (MS) has long been a controversial topic. After the publication of the first large prospective study of pregnancy and MS in 1998, counselling of women with MS has radically changed and many patients have been able to fulfill their desire of motherhood. However, there are still some challenges for the neurologist, who has to face old unanswered questions or new issues, regarding the use of disease modifying drugs (DMDs) in this period of life, effects on the short and long term outcome of the mother (in terms of relapses and disability) and the child, role of breast-feeding and locoregional analgesia.
To set up a national prospective pregnancy registry for patients with MS, nested within the Observatoire Français de la Sclérose en Plaque (OFSEP) cohort, owing to a better knowledge of interactions between MS and pregnancy-related issues (pregnancy itself, locoregional analgesia, breastfeeding, impact of using or stopping DMDs on women/children…)
Detailed description
METHODOLOGY Prospective, observational, multicentric and national epidemiological study, within the scope of the OFSEP, including all groups of patients eligible to participate in the Observatoire Français de la Sclérose en Plaque (OFSEP) (definite MS, radiologically isolated syndromes, clinically isolated syndromes, neuromyelitis optica (NMO) and NMO spectrum disorders), with no age limit and an ongoing pregnancy. Women will be followed during pregnancy and in the year after and their children until 6 years of age.
STATISTICAL ANALYSIS To be determined for each specific question. EXPECTED RESULTS Interactions between pregnancy and MS course have been well characterized before the therapeutic era. Neurologists and patients are lacking information to weigh benefits and risks of DMDs used immediately before or during pregnancy, including short and long-term risks to the mother and to the child, but also after delivery. This study should help provide better answers to those questions as well as to still controversial questions about locoregional analgesia and breastfeeding. By following these patients within the Observatoire Français de la Sclérose en Plaque (OFSEP) cohort, the investigator will also have access to a comprehensive description of MS before pregnancy but also in the long term.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women with multiple sclerosis or related neurological | – | Other: No interventionChildren born to women with multiple sclerosis or related neurological syndromes. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant women with multiple sclerosis or related neurological syndromes
Key inclusion criteria (10 listed)
- All groups of patients eligible to participate to the Observatoire Français de la Sclérose en Plaque (OFSEP), including :
- Definite Multiple sclerosis (MS) according to McDonald criteria
- Whatever the clinical course (single attack MS, relapsing-remitting MS, secondary progressive MS, primary progressive MS)
- Radiologically Isolated Syndromes (RIS) (will be validated by the RIS expert group)
- Clinically Isolated Syndromes (CIS)
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| No interventionNo intervention | Other | Pregnant women with multiple sclerosis or related neurological |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 during pregnancy period
Time frame: up to 2 years
Description of the current neurological practice of French neurologists regarding disease modifying drugs and desire of pregnancy and evaluation of its short term impact on the risk of relapses.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 during post-partum period
Time frame: up to 2 years
Description of the current neurological practice of French neurologists regarding disease modifying drugs and desire of pregnancy and evaluation of its short term impact on the risk of relapses.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
- Related InfoLink provided by the sponsor.
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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.
Sandra VUKUSIC, Prof. principal investigator
Hospices Civils de Lyon
48 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sclerosis, Multiple and Neuromyelitis Optica Spectrum Disorder, run by Hospices Civils de Lyon at 48 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 10 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: looking for participants now, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sandra VUKUSIC, Prof. (4 72 68 13 13 ext. +33, sandra.vukusic@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 during pregnancy period (time frame: up to 2 years). The study lists 2 primary outcomes in all. 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 5 Jan 2026.