Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03900221
Other study ID # 69HCL18_0631
Secondary ID 2018-A02552-53
Status Recruiting
Phase
First received
Last updated
Start date August 12, 2019
Est. completion date August 12, 2036

Study information

Verified date June 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
Health authority
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, 2036
Est. primary completion date August 12, 2036
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Recruiting NCT04561557 - Safety and Efficacy of CT103A Cells for Relapsed/Refractory Antibody-associated Inflammatory Diseases of the Nervous System Early Phase 1
Completed NCT03002038 - Comparison of Clinical Effects of Azathioprine and Rituximab NMO-SD Patients Phase 2/Phase 3
Not yet recruiting NCT04064944 - Comparison of the Efficacy and Safety of Immunoadsorption and Plasma Exchange for Acute Attack of Refractory Neuromyelitis Optica Spectrum Disorders Phase 2
Recruiting NCT05414487 - Effects of Ofatumumab Treatment on Immune Cells and Meningeal Lymphatic Drainage in Patients With Demyelinating Diseases
Not yet recruiting NCT05551598 - Efficacy and Safety of Mitoxantrone Hydrochloride Liposome Injection in the Treatment of Neuromyelitis Optica Spectrum Disorder (NMOSD) Phase 2
Recruiting NCT05403138 - Safety and Efficacy of Daratumumab in Patients With Anti-Aquaporin 4 Antibody Positive Neuromyelitis Optica Spectrum Disorders Phase 2/Phase 3
Completed NCT01845584 - Phase II Clinical Trial of NPB-01 in Patients With Anti-aquaporin 4 Antibody Positive Neuromyelitis Optica Spectrum Disorder Not Provided Adequate Effect of Therapy to Steroids Plus Therapy. Phase 2
Completed NCT04660539 - A Study to Evaluate the Safety and Efficacy of Satralizumab in Participants With Neuromyelitis Optica Spectrum Disorder (NMOSD) Phase 3
Recruiting NCT05199688 - A Study To Evaluate Pharmacokinetics, Efficacy, Safety, Tolerability, And Pharmacodynamics Of Satralizumab In Pediatric Patients With Aquaporin-4 Antibody Positive Neuromyelitis Optica Spectrum Disorder (NMOSD) Phase 3
Recruiting NCT05504694 - Ofatumumab in AQP4-IgG Seropositive NMOSD Phase 1/Phase 2
Recruiting NCT05346354 - Efficacy and Safety Study of Ravulizumab IV in Pediatric Participants With NMOSD Phase 2/Phase 3
Completed NCT01777412 - Efficacy of Bevacizumab (Avastin) in Treatment of Acute NMO Exacerbations Phase 1
Recruiting NCT01623076 - The Longitudinal CONQUER Study of Rare Neuroimmunologic Disorders
Completed NCT01500681 - Maintenance Plasma Exchange for Neuromyelitis Optica
Not yet recruiting NCT06374264 - Acceptability and Safety of MR-C-014 in Persons With Neuromyelitis Optica Spectrum Disorder N/A
Not yet recruiting NCT05891379 - Inebilizumab in Acute Neuromyelitis Optica Spectrum Disorders
Recruiting NCT05909761 - Observational Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® During Pregnancy
Completed NCT02276963 - Ublituximab for Acute Neuromyelitis Optica (NMO) Relapses Phase 1
Terminated NCT04155424 - A Study of the Safety and Activity of Eculizumab in Pediatric Participants With Relapsing Neuromyelitis Optica Spectrum Disorder Phase 2/Phase 3
Completed NCT02003144 - An Open Label Extension Trial of Eculizumab in Relapsing NMO Patients Phase 3

External Links