French Registry for Monitoring Pregnancies for Multiple Sclerosis

Neuromyelitis Optica Spectrum Disorder Clinical Trial

— RESPONSE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03900221
• Other study ID #: 69HCL18_0631
• Secondary ID: 2018-A02552-53
• Status: Recruiting
• Start date: August 12, 2019
• Est. completion date: August 12, 2030

Study information

• Verified date: January 2024
• Source: Hospices Civils de Lyon
• Contact: Sandra VUKUSIC, Prof.
• Phone: 4 72 68 13 13
• Email: sandra.vukusic[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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…)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: August 12, 2030
• Est. primary completion date: August 12, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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)
• 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

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Multiple Sclerosis
• Myelin Oligodendrocyte Glycoprotein (MOG)-Antibody Related Disorders
• Neuromyelitis Optica
• Neuromyelitis Optica Spectrum Disorder
• Pregnancy Abnormal
• Sclerosis
• Sclerosis, Multiple

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
France	Chu D'Amiens	Amiens
France	Hopital Jean Minjoz	Besançon
France	Hopital Pellegrin	Bordeaux
France	Hôpital Neurologique Pierre Wertheimer	Bron
France	Hopital Cote de Nacre	Caen
France	Hopital Gabriel Montpied	Clermont-Ferrand
France	Centre Hospitalier Sud Francilien	Corbeil-Essonnes
France	Hopital Henri Mondor	Créteil
France	Hopital Du Bocage	Dijon
France	Chu de Grenoble	Grenoble
France	Centre Hospitalier de Versailles Hôpital Andre Mignot	Le Chesnay
France	Chru de Lille	Lille
France	Hopital Dupuytren	Limoges
France	Hopital Timone Adultes	Marseille
France	Hopital Gui de Chauliac	Montpellier
France	Hôpital Central	Nancy
France	Hopital Pasteur	Nice
France	Hopital Caremeau	Nîmes
France	Fondation Rotschild	Paris
France	Hopital Pitie Salpetriere	Paris
France	Hopital Saint Antoine	Paris
France	Chi Poissy Saint Germain En Laye	Poissy
France	Chr La Miletrie	Poitiers
France	Hopital Rene Dubos	Pontoise
France	Hopital de La Maison Blanche	Reims
France	Hopital Pontchaillou	Rennes
France	Hôpital Charles-Nicolle	Rouen
France	Centre Hospitalier de Saint-Denis	Saint-Denis
France	Hopital G. Et R. Laennec	Saint-Herblain
France	Hopital Nord	Saint-Priest-en-Jarez
France	Hopital Hautepierre	Strasbourg
France	Hopital Purpan	Toulouse
France	Chru de Tours Hopital Bretonneau	Tours
Martinique	Hopital P. Zobda-Quitman	Fort-de-France

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Countries where clinical trial is conducted

France,  Martinique, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 2 years
Primary	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.	up to 2 years

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