Preventive Use of COrticosteroids During the Post-Partum in Relapsing MS Patients (COPP-MS) (COPP-MS)
9 novembre 2020 mis à jour par: Rennes University Hospital
Preventive Use of COrticosteroids During the Post-Partum in Relapsing MS
Multiple Sclerosis (MS) is most prevalent among women of childbearing age. The post-partum (PP) period is a critical phase in MS patients, during which a recrudescence of disease activity is expected. Different strategies have been assessed in the prevention of post-partum relapse. High dose methylprednisolone was evaluated in a case control study with historical controls but the positive results have not been confirmed.
In this study, the main objective will be to compare the risk of relapse in the 6 months PP period between patients treated systematically by high dose methylprednisolone after delivery compared to patients who didn't receive a systematic treatment.
The second objective will be focused on the comparison of the disease activity and disability progression in patients who have resumed early a Disease Modifying Drug (DMD) after delivery vs patients who haven't.
Aperçu de l'étude
Statut
Complété
Les conditions
Description détaillée
Even if two small case control studies underlined the positive effect of high dose methylprednisolone on the relapse risk in the PP period in MS, these data have to be confirmed by a larger study.
The impact of such a strategy remains also uncertain concerning the risk of long term disability.
In this project, the investigators will also analyze the influence of the delay of DMD reintroduction after delivery on the relapse risk but also on the risk of disability.
The results will have an important role in the therapeutic management of the post-partum period in MS patients.
Type d'étude
Observationnel
Inscription (Réel)
350
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Lyon, France
- CHU Lyon
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Nice, France, 06000
- Hôpital Pasteur 2 - CHU Nice
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Rennes, France, 35033
- CHU Rennes
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Strasbourg, France, 67098
- CHU Strasbourg
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Nantes
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Saint Herblain, Nantes, France, 44800
- Hôpital Laënnec
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
15 ans à 49 ans (Enfant, Adulte)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Femelle
Méthode d'échantillonnage
Échantillon de probabilité
Population étudiée
relapsing MS patients with at least one full pregnancy with live birth between 01/2007 and 01/2017 after the beginning of the MS diagnosis
La description
Inclusion Criteria:
- Relapsing MS patients according to MacDonald criteria 2010
- Age between 15 and 49 years old at the pregnancy
- Age between 18 and 51 years old when filling the questionnaire of the study
- At least one full pregnancy with live birth after the beginning of the MS diagnosis
- At least one neurological visit during the 12 months period after the delivery
- At least one neurological visit per year in the 12 months preceding the pregnancy
- Pregnancy must occur between 01/2007 and 01/2017 In case of several pregnancies per woman, only the first one occurring in the period will be analyzed
- Having received information on the protocol and not having expressed opposition to participating in the study.
Exclusion Criteria:
- Patients who have received Immunoglobulines or plasma exchanges after the delivery in prevention of a relapse
- Patients presenting a SPMS or PPMS form at the beginning of pregnancy
- Protected persons referred to in Articles L. 1121-6 to L. 1121-9 of the code of public health (eg minors, persons deprived of liberty, ..) except nursing mothers postpartum.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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Patients with corticosteroids
Patients who have systematically been treated by high-dose corticosteroids after the delivery
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Patients without corticosteroids
Patients who haven't been systematically treated by high-dose corticosteroids after the delivery.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Difference of the proportion of patients with >= 1 relapse between the two groups
Délai: 6 months
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proportion of patients with >= 1 relapse during the six-month period after delivery between the patients who have systematically been treated by high-dose corticosteroids after the delivery; and patients who haven't been systematically treated by high-dose corticosteroids.
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6 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Difference of the proportion of patients with >= 1 relapse
Délai: 6 months
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proportion of patients with >= 1 relapse during the six-month period after delivery between patients who have resumed a DMD early after the delivery (during the first two months) compared to a delayed reintroduction, or an absence of reintroduction
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6 months
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Difference of the annualized relapse rate
Délai: 6 months
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Number of the annualized relapse rate after the delivery between corticosteroids or not and between early DMD vs delayed DMD
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6 months
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Difference of the annualized relapse rate
Délai: 1 year
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Number of the annualized relapse rate after the delivery between corticosteroids or not and between early DMD vs delayed DMD
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1 year
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Difference of the annualized relapse rate
Délai: two years
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Number of the annualized relapse rate after the delivery between corticosteroids or not and between early DMD vs delayed DMD
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two years
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Difference of the time to first relapse
Délai: Date of delivery
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Time to first relapse after delivery between corticosteroids or not and between early DMD vs delayed DMD
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Date of delivery
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Difference of the disability progression
Délai: 6 months
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Score of Expanded Disability Status Scale (EDSS) (from 0=no disability, to 10= Death / No sub scales) between corticosteroids or not and between early DMD vs delayed DMD
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6 months
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Difference of the disability progression
Délai: 1 year
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Score of Expanded Disability Status Scale (EDSS) (from 0=no disability, to 10= Death / No sub scales) between corticosteroids or not and between early DMD vs delayed DMD
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1 year
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Difference of the disability progression
Délai: 2 years
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Score of Expanded Disability Status Scale (EDSS) (from 0=no disability, to 10= Death / No sub scales) between corticosteroids or not and between early DMD vs delayed DMD
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2 years
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Difference of percentage of with Gadolinium enhancing lesions
Délai: 6 months
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Difference of percentage of with Gadolinium enhancing lesions during the 6-month period after the delivery between corticosteroids or not and between early DMD vs delayed DMD
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6 months
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Difference of the number of Gadolinium enhancing lesions
Délai: 6 months
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compare the number of Gadolinium enhancing lesions during the 6-month period after the delivery between corticosteroids or not and between early DMD vs delayed DMD
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6 months
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Laure MICHEL, Dr, CHU Rennes
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
20 juin 2019
Achèvement primaire (Réel)
18 mai 2020
Achèvement de l'étude (Réel)
18 mai 2020
Dates d'inscription aux études
Première soumission
12 avril 2019
Première soumission répondant aux critères de contrôle qualité
12 avril 2019
Première publication (Réel)
17 avril 2019
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
10 novembre 2020
Dernière mise à jour soumise répondant aux critères de contrôle qualité
9 novembre 2020
Dernière vérification
1 novembre 2020
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 35RC18_9844_COPP-MS
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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