Brain Imaging and Immune Changes During Remibrutinib Treatment in Multiple Sclerosis. (REDIFINE MS)
5. August 2026 aktualisiert von: 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.
Studienübersicht
Status
Rekrutierung
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Beobachtungs
Einschreibung (Geschätzt)
15
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Nicole Shelley
- Telefonnummer: 314-362-7666
- E-Mail: nshelley@wustl.edu
Studieren Sie die Kontaktsicherung
- Name: Kelley M Jackson, BS
- Telefonnummer: 314-362-3613
- E-Mail: kelleyj@wustl.edu
Studienorte
-
-
Missouri
-
St Louis, Missouri, Vereinigte Staaten, 63110
- Rekrutierung
- Washington University School of Medicine in St. Louis
-
Hauptermittler:
- Matthew R Brier, MD, PhD
-
Kontakt:
- Nicole Shelley
- Telefonnummer: 314-362-7666
- E-Mail: nshelley@wustl.edu
-
Kontakt:
- Kelley M Jackson, BS
- Telefonnummer: 314-362-3613
- E-Mail: kelleyj@wustl.edu
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Probenahmeverfahren
Nicht-Wahrscheinlichkeitsprobe
Studienpopulation
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
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
|
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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in Microglial Activity Measured by [11C]-DPA-713 PET
Zeitfenster: 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.
|
Baseline and 6 months after randomization
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Mitarbeiter
Ermittler
- Hauptermittler: Matthew R Brier, MD, PhD, Washington University School of Medicine
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
15. August 2026
Primärer Abschluss (Geschätzt)
15. August 2029
Studienabschluss (Geschätzt)
29. August 2030
Studienanmeldedaten
Zuerst eingereicht
5. August 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
5. August 2026
Zuerst gepostet (Tatsächlich)
11. August 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
11. August 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
5. August 2026
Zuletzt verifiziert
1. August 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen des Nervensystems
- Pathologische Prozesse
- Autoimmunerkrankungen
- Erkrankungen des Immunsystems
- Entzündung
- Demyelinisierende Autoimmunerkrankungen, ZNS
- Autoimmunerkrankungen des Nervensystems
- Demyelinisierende Krankheiten
- Pathologische Zustände, Anzeichen und Symptome
- Neuroinflammatorische Erkrankungen
- Multiple Sklerose
- Multiple Sklerose, schubförmig remittierend
- Ocrelizumab
- Remibrutinib
Andere Studien-ID-Nummern
- REDIFINE MS
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Ja
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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