Multiple Sclerosis (MS) - Relapsing-remitting
Conditions
Keywords
Multiple Sclerosis, Relapsing Multiple Sclerosis and Neuroinflammation
Brief summary
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.
Detailed description
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.
Interventions
DRUGRemibrutinib
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.
DRUGOcrelizumab (US)
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.
Sponsors
Washington University School of Medicine
Novartis
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Microglial Activity Measured by [11C]-DPA-713 PET | 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. |
Countries
United States
Contacts
CONTACTNicole Shelley
CONTACTKelley M Jackson, BS
PRINCIPAL_INVESTIGATORMatthew R Brier, MD, PhD
Washington University School of Medicine
Outcome results
None listed