Preventive Use of COrticosteroids During the Post-Partum in Relapsing MS Patients (COPP-MS) (COPP-MS)
2020年11月9日 更新者：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.
調査の概要
状態
完了
条件
詳細な説明
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.
研究の種類
観察的
入学 (実際)
350
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Lyon、フランス
- CHU LYON
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Nice、フランス、06000
- Hôpital Pasteur 2 - CHU Nice
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Rennes、フランス、35033
- CHU Rennes
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Strasbourg、フランス、67098
- CHU Strasbourg
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Nantes
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Saint Herblain、Nantes、フランス、44800
- Hôpital Laënnec
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
15年～49年 (子、大人)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
女性
サンプリング方法
確率サンプル
調査対象母集団
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
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
|---|
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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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Difference of the proportion of patients with >= 1 relapse between the two groups
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Difference of the proportion of patients with >= 1 relapse
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Laure MICHEL, Dr、CHU Rennes
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2019年6月20日
一次修了 (実際)
2020年5月18日
研究の完了 (実際)
2020年5月18日
試験登録日
最初に提出
2019年4月12日
QC基準を満たした最初の提出物
2019年4月12日
最初の投稿 (実際)
2019年4月17日
学習記録の更新
投稿された最後の更新 (実際)
2020年11月10日
QC基準を満たした最後の更新が送信されました
2020年11月9日
最終確認日
2020年11月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 35RC18_9844_COPP-MS
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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