Brain Imaging and Immune Changes During Remibrutinib Treatment in Multiple Sclerosis. (REDIFINE MS)
2026年8月5日 更新者：Matthew Brier、Washington University School of Medicine
REMIBRUTINIB: EVALUATION OF FLUID AND INFLAMMATORY NEUROIMAGING ENDPOINTS IN MULTIPLE SCLEROSIS (REDEFINE-MS)
REDEFINE-MS is a research study for people with relapsing multiple sclerosis (MS) who are participating in the RESHAPE-MS trial.
The study aims to better understand how remibrutinib affects inflammation in the brain and spinal cord by using PET imaging, MRI scans, blood samples, and cerebrospinal fluid (CSF) samples collected before treatment and again six months later.
[REDEFINE_p...2026_clean | Word] The main question the study is trying to answer is whether remibrutinib changes immune activity and inflammation in people with MS, and whether these changes can be measured using imaging and biological markers that may help predict future disease progression and treatment response.
調査の概要
詳細な説明
Multiple sclerosis (MS) is associated with ongoing inflammation within the central nervous system that may contribute to disease progression even when relapses are controlled.
Remibrutinib, a Bruton tyrosine kinase (BTK) inhibitor, may affect immune cells involved in this process, but its effects on inflammation within the brain and spinal cord are not fully understood.
[REDEFINE_p...2026_clean | Word] This study will evaluate changes in neuroinflammation and immune activity in participants with relapsing MS by combining advanced imaging and biomarker assessments.
Measurements of microglial activity using positron emission tomography (PET), cerebrospinal fluid (CSF) analyses, blood-based biomarkers, and magnetic resonance imaging (MRI) will be used to assess changes associated with remibrutinib treatment.
[REDEFINE_p...2026_clean | Word] The study will examine whether changes in imaging and fluid biomarkers are associated with measures of disease severity and whether these biomarkers may help predict longer-term clinical outcomes.
Results may improve understanding of the biological effects of BTK inhibition in MS and help identify biomarkers that can be used to monitor treatment response and disease progression.
研究の種類
観察的
入学 (推定)
15
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。
研究連絡先
- 名前：Nicole Shelley
- 電話番号：314-362-7666
- メール：nshelley@wustl.edu
研究連絡先のバックアップ
- 名前：Kelley M Jackson, BS
- 電話番号：314-362-3613
- メール：kelleyj@wustl.edu
研究場所
-
-
Missouri
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St Louis、Missouri、アメリカ、63110
- 募集
- Washington University School of Medicine in St. Louis
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主任研究者：
- Matthew R Brier, MD, PhD
-
コンタクト：
- Nicole Shelley
- 電話番号：314-362-7666
- メール：nshelley@wustl.edu
-
コンタクト：
- Kelley M Jackson, BS
- 電話番号：314-362-3613
- メール：kelleyj@wustl.edu
-
-
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
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
サンプリング方法
非確率サンプル
調査対象母集団
The exclusion criteria of the parent study are adapted and inherited under this section (See parent study protocol section 5.2). In addition, the following exclusion criteria apply:
- Hypersensitivity to [11C]-DPA-713 or any of its excipients
- Contraindications to PET or MRI (e.g. certain incompatible electronic medical devices, inability to lie still for extended periods) that make it potentially unsafe for the individual to participate
- Presence of a low affinity binding TSPO polymorphism.
- Any condition that, in the opinion of the Principal Investigator or his designee, could increase the risk to the participant or limits their ability to participate (e.g., liver or kidney disease, advanced cancer)
- Current or recent (within 12 months prior to screening) participation in research studies involving radioactive agents such that the total research-related radiation dose to the participant in any given year would exceed the limits set forth in the U.S. Code of Federal Regulations (C
説明
Inclusion Criteria
- Capable of providing written informed consent for volunteering to undergo research procedures.
- Male or female, any race
- Age between 40 and 70 years of age, inclusive
- Diagnosis of RMS according to revised 2017 McDonald criteria at screening 15
- EDSS score of 0 to 6.5 (inclusive) at screening
- Treated with ocrelizumab according to routine clinical practice and at standard dose for at least 18 months. The last administration of ocrelizumab must have occurred within 5 to 9 months prior to randomization.
- Neurologically stable within 30 days prior to screening, including no MS relapse during this period.
- Suitable to be switched to remibrutinib based on physician judgement or patient preference.
Exclusion Criteria:
The exclusion criteria of the parent study are adapted and inherited under this section (See parent study protocol section 5.2). In addition, the following exclusion criteria apply:
- Hypersensitivity to [11C]-DPA-713 or any of its excipients
- Contraindications to PET or MRI (e.g. certain incompatible electronic medical devices, inability to lie still for extended periods) that make it potentially unsafe for the individual to participate
- Presence of a low affinity binding TSPO polymorphism.
- Any condition that, in the opinion of the Principal Investigator or his designee, could increase the risk to the participant or limits their ability to participate (e.g., liver or kidney disease, advanced cancer)
- Current or recent (within 12 months prior to screening) participation in research studies involving radioactive agents such that the total research-related radiation dose to the participant in any given year would exceed the limits set forth in the U.S. Code of Federal Regulations (CFR) Title 21 Section 361.1. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=361.1.
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 |
介入・治療 |
|---|---|
|
Cohort 1
Participants randomized to remibrutinib in the parent RESHAPE-MS study.
|
Participants with relapsing multiple sclerosis enrolled in the parent RESHAPE-MS study who are randomized to receive remibrutinib.
Participants undergo PET imaging, MRI, blood collection, and cerebrospinal fluid collection as part of REDEFINE-MS.
|
|
Cohort 2
Participants randomized to ocrelizumab in the parent RESHAPE-MS study.
|
Participants with relapsing multiple sclerosis enrolled in the parent RESHAPE-MS study who are randomized to continue ocrelizumab.
Participants undergo PET imaging, MRI, blood collection, and cerebrospinal fluid collection as part of REDEFINE-MS.
|
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 |
|---|---|---|
|
Change in Microglial Activity Measured by [11C]-DPA-713 PET
時間枠：Baseline and 6 months after randomization
|
Change in regional [11C]-DPA-713 PET distribution volume ratio (DVR) from baseline to 6 months, comparing participants receiving remibrutinib with those receiving ocrelizumab.
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Baseline and 6 months after randomization
|
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。
協力者
捜査官
- 主任研究者：Matthew R Brier, MD, PhD、Washington University School of Medicine
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 (推定)
2026年8月15日
一次修了 (推定)
2029年8月15日
研究の完了 (推定)
2030年8月29日
試験登録日
最初に提出
2026年8月5日
QC基準を満たした最初の提出物
2026年8月5日
最初の投稿 (実際)
2026年8月11日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月11日
QC基準を満たした最後の更新が送信されました
2026年8月5日
最終確認日
2026年8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
- REDIFINE MS
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
はい
米国FDA規制機器製品の研究
いいえ
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