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French Registry for Monitoring Pregnancies for Multiple Sclerosis (RESPONSE)

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ClinicalTrials.gov Identifier: NCT03900221
Recruitment Status : Not yet recruiting
First Posted : April 2, 2019
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief 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…)


Condition or disease Intervention/treatment
Sclerosis, Multiple Neuromyelitis Optica Spectrum Disorder Myelin Oligodendrocyte Glycoprotein (MOG)-Antibody Related Disorders Pregnancy Abnormal Other: No intervention

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
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
Estimated Study Start Date : April 29, 2019
Estimated Primary Completion Date : August 2032
Estimated Study Completion Date : August 1, 2032


Group/Cohort Intervention/treatment
Pregnant women with multiple sclerosis or related neurological
Children born to women with multiple sclerosis or related neurological syndromes.
Other: No intervention
No intervention




Primary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women with multiple sclerosis or related neurological syndromes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03900221


Contacts
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Contact: Sandra VUKUSIC, Prof. 4 72 68 13 13 ext +33 sandra.vukusic@chu-lyon.fr
Contact: Romain MARIGNIER, MD 4 72 68 13 13 ext +33 romain.marignier@chu-lyon.fr

Locations
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France
Chu D'Amiens Not yet recruiting
Amiens, France, 80054
Contact: Abdullatif AL KHEDR         
Principal Investigator: Abdullatif AL KHEDR         
Hopital Jean Minjoz Not yet recruiting
Besançon, France, 25030
Contact: Eric BERGER         
Principal Investigator: Eric BERGER         
Hopital Pellegrin Not yet recruiting
Bordeaux, France, 33076
Contact: Bruno BROCHET         
Principal Investigator: Bruno BROCHET         
Hôpital Neurologique Pierre Wertheimer Not yet recruiting
Bron, France, 69677
Contact: Sandra VUKUSIC    4 72 68 13 13 ext +33    sandra.vukusic@chu-lyon.fr   
Principal Investigator: Sandra VUKUSIC         
Hopital Cote de Nacre Not yet recruiting
Caen, France, 14033
Contact: Gilles DEFER         
Principal Investigator: Gilles DEFER         
Hopital Gabriel Montpied Not yet recruiting
Clermont-Ferrand, France, 63003
Contact: Pierre CLAVELOU         
Principal Investigator: Pierre CLAVELOU         
Centre Hospitalier Sud Francilien Not yet recruiting
Corbeil-Essonnes, France, 91100
Contact: Ivania PATRY         
Principal Investigator: Ivania PATRY         
Hopital Henri Mondor Not yet recruiting
Créteil, France, 94010
Contact: Alain CREANGE         
Principal Investigator: Alain CREANGE         
Hopital Du Bocage Not yet recruiting
Dijon, France, 21079
Contact: Thibault MOREAU         
Principal Investigator: Thibault MOREAU         
Chu de Grenoble Not yet recruiting
Grenoble, France, 38043
Contact: Olivier CASEZ         
Principal Investigator: Olivier CASEZ         
Centre Hospitalier de Versailles Hôpital Andre Mignot Not yet recruiting
Le Chesnay, France, 78157
Contact: Chantal NIEFLE         
Principal Investigator: Chantal NIEFLE         
Chru de Lille Not yet recruiting
Lille, France, 59037
Contact: Patrick VERMERSCH         
Principal Investigator: Patrick VERMERSCH         
Hopital Dupuytren Not yet recruiting
Limoges, France, 87042
Contact: Laurent MAGY         
Principal Investigator: Laurent MAGY         
Hopital Timone Adultes Not yet recruiting
Marseille, France, 13385
Contact: Jean PELLETIER         
Principal Investigator: Jean PELLETIER         
Hopital Gui de Chauliac Not yet recruiting
Montpellier, France, 34295
Contact: Pierre LABAUGE         
Principal Investigator: Pierre LABAUGE         
Hôpital Central
Nancy, France, 54035
Hopital Pasteur Not yet recruiting
Nice, France, 06001
Contact: Christine LEBRUN-FRENAY         
Principal Investigator: Christine LEBRUN-FRENAY         
Hopital Caremeau Not yet recruiting
Nîmes, France, 30029
Contact: Eric THOUVENOT         
Principal Investigator: Eric THOUVENOT         
Fondation Rotschild Not yet recruiting
Paris, France, 75019
Contact: Olivier GOUT         
Principal Investigator: Olivier GOUT         
Hopital Saint Antoine Not yet recruiting
Paris, France, 75570
Contact: Bruno STANKOFF         
Principal Investigator: Bruno STANKOFF         
Hopital Pitie Salpetriere Not yet recruiting
Paris, France, 75651
Contact: Catherine LUBETZKI         
Principal Investigator: Catherine LUBETZKI         
Chi Poissy Saint Germain En Laye Not yet recruiting
Poissy, France, 78303
Contact: Olivier HEINZLEF         
Principal Investigator: Olivier HEINZLEF         
Chr La Miletrie Not yet recruiting
Poitiers, France, 86021
Contact: Jean-Philippe NEAU         
Principal Investigator: Jean-Philippe NEAU         
Hopital Rene Dubos Not yet recruiting
Pontoise, France, 95300
Contact: Corinne DUPEL-POTTIER         
Principal Investigator: Corinne DUPEL-POTTIER         
Hopital de La Maison Blanche Not yet recruiting
Reims, France, 51092
Contact: Ayman TOURBAH         
Principal Investigator: Ayman TOURBAH         
Hopital Pontchaillou Not yet recruiting
Rennes, France, 35033
Contact: Gilles EDAN         
Principal Investigator: Gilles EDAN         
Hôpital Charles-Nicolle Not yet recruiting
Rouen, France, 76000
Contact: Bertrand BOURRE         
Principal Investigator: Bertrand BOURRE         
Centre Hospitalier de Saint-Denis Not yet recruiting
Saint-Denis, France, 93200
Contact: Thomas DEBROUCKER         
Principal Investigator: Thomas DEBROUCKER         
Hopital G. Et R. Laennec Not yet recruiting
Saint-Herblain, France, 44800
Contact: David LAPLAUD         
Principal Investigator: David LAPLAUD         
Hopital Nord Not yet recruiting
Saint-Priest-en-Jarez, France, 42277
Contact: Jean-Philippe CAMDESSANCHE         
Principal Investigator: Jean-Philippe CAMDESSANCHE         
Hopital Hautepierre Not yet recruiting
Strasbourg, France, 67098
Contact: Jérôme DE SEZE         
Principal Investigator: Jérôme DE SEZE         
Hopital Purpan Not yet recruiting
Toulouse, France, 31059
Contact: David BRASSAT         
Principal Investigator: David BRASSAT         
Chru de Tours Hopital Bretonneau Not yet recruiting
Tours, France, 37044
Contact: Anne-Marie GUENNOC         
Principal Investigator: Anne-Marie GUENNOC         
Martinique
Hopital P. Zobda-Quitman Not yet recruiting
Fort-de-France, Martinique, 97200
Contact: Philippe CABRE         
Principal Investigator: Philippe CABRE         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Sandra VUKUSIC, Prof. Hospices Civils de Lyon

Additional Information:
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03900221     History of Changes
Other Study ID Numbers: 69HCL18_0631
2018-A02552-53 ( Other Identifier: ID-RCB )
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hospices Civils de Lyon:
Multiple sclerosis
pregnancy
disease modifying drugs
breastfeeding
loco-regional analgesia

Additional relevant MeSH terms:
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Disease
Sclerosis
Multiple Sclerosis
Neuromyelitis Optica
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Myelitis, Transverse
Optic Neuritis
Optic Nerve Diseases
Cranial Nerve Diseases
Eye Diseases