Preventive Use of COrticosteroids During the Post-Partum in Relapsing MS Patients (COPP-MS) (COPP-MS)
9. november 2020 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
350
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Lyon, Frankrig
- CHU Lyon
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Nice, Frankrig, 06000
- Hôpital Pasteur 2 - CHU Nice
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Rennes, Frankrig, 35033
- CHU Rennes
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Strasbourg, Frankrig, 67098
- CHU Strasbourg
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Nantes
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Saint Herblain, Nantes, Frankrig, 44800
- Hôpital Laënnec
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
15 år til 49 år (Barn, Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
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
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Difference of the proportion of patients with >= 1 relapse between the two groups
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Difference of the proportion of patients with >= 1 relapse
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Laure MICHEL, Dr, CHU Rennes
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
20. juni 2019
Primær færdiggørelse (Faktiske)
18. maj 2020
Studieafslutning (Faktiske)
18. maj 2020
Datoer for studieregistrering
Først indsendt
12. april 2019
Først indsendt, der opfyldte QC-kriterier
12. april 2019
Først opslået (Faktiske)
17. april 2019
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
10. november 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
9. november 2020
Sidst verificeret
1. november 2020
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 35RC18_9844_COPP-MS
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