出口療法戦略としてのクラドリビン錠剤 (CLADREXIT)
出口療法戦略としてのクラドリビン錠剤:老化した安定したRMS患者の継続的な治療と単純な治療の中止に代わる
The objective of the study is to evaluate the effectiveness of CladT, in terms of disease stability and safety, as the last treatment option in ageing MS patients vs treatment continuation and discontinuation This observational study will use database from local cohorts (from France, Belgium, Switzerland). Patients included must meet the inclusion criteria: RRMS diagnosis for more than 10 years without secondary progression, no evidence of disease activity (no relapse, no new MRI lesion, no EDSS progression) for more than 5 years under a DMT, age≥ 45-year-old.
Analyses will be using dynamic propensity score to match patients who stopped treatment with patients who had the same probability of continuing / stopping current treatments but took CladT as exit therapy. Patients with a minimum of 24 months follow up will be included.
The investigators will ensure that CladT provide disease stability compared to treatment continuation / discontinuation in ageing MS patients by measuring:
- the percentage of patients free of relapse, and time to first relapse, defined as the appearance, recurrence, or aggravation of neurological symptoms for a period of at least 24 hours without fever.
- the percentage of patients free of EDSS progression confirmed for at least 6 months and until the end of patient follow up.
- the percentage of patients free of MRI activity, defined as new or enlarged T2 lesions compared with the previous brain MRI scan or gadolinium enhancing T1 lesions.
調査の概要
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
-
Strasbourg、フランス、67000
- Service de neurologie - Hôpitaux Universitaires de Strasbourg
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
This is a multicentric retrospective and controlled cohort with non-inferiority analysis. Patients will be matched 1:1 using propensity score on gender, age, MS duration, time before last relapse, EDSS score, DMTs.
The study will use retrospectively collected data within the date frame from 06/30/25 to 06/30/26.
Approximately 150 patients treated with cladribine will be identified and included in this study in 7 centers: Strasbourg, Lille, Montpellier, Nimes, Liège, Pelt, Lugano.
説明
Inclusion Criteria:
- Patient ≥45-year-old with RRMS
- Disease duration ≥10 years
- No evidence of disease activity ≥5 years under DMT
- EDSS score between 0 and 6.0 included
Exclusion Criteria:
- Progressive form of MS
- Patients without DMT
- EDSS score ≥6.5
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 観測モデル:COHORT
- 時間の展望:RETROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
クラドリビングループ
|
To evaluate the clinical activity during the 2 years of follow-up in patients switching to cladribine and continuing current DMT |
|
継続的な治療グループ
|
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 |
|---|---|---|
|
To evaluate the clinical activity during the 2 years of follow-up in patients switching to cladribine and continuing current DMT
時間枠:2 years
|
Proportion of patients with relapses* and time to event during the 2 years of follow-up in patients switching to cladribine and continuing current DMT |
2 years
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
To evaluate the clinical activity during the 2 years of follow-up in patients switching to cladribine and stopping current DMT
時間枠:2 years
|
Proportion of patients with relapse and time to event during the 2 years of follow-up in patients switching to cladribine and stopping current DMT |
2 years
|
|
To evaluate the clinical activity during the 3 years of follow-up in patients switching to cladribine and continuing current DMT
時間枠:2 years
|
Proportion of patients with relapse and time to event during the 2 years of follow-up in patients switching to cladribine and continuing current DMT |
2 years
|
|
To evaluate the radiological activity during the follow-up in patients switching to cladribine, continuing current DMT and stopping DMT
時間枠:2 years
|
Proportion of patients with new T2 lesions on brain MRI at 1 and 2 years in patients switching to cladribine, continuing current DMT and stopping DMT |
2 years
|
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To evaluate the disability during the follow-up in patients switching to cladribine, continuing current DMT and stopping DMT
時間枠:2 years
|
Proportion of patients with EDSS worsening** after 2 years in patients switching to cladribine, continuing current DMT and stopping DMT |
2 years
|
|
To evaluate the risk of serious adverse events in patients switching to cladribine and continuing current DMT
時間枠:2 years
|
Proportion of patients with any serious adverse events after 2 years in patients switching to cladribine and continuing current DMT |
2 years
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
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
- 9628
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?
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