REMIBRUTINIB: EVALUATION OF FLUID AND INFLAMMATORY NEUROIMAGING ENDPOINTS IN MULTIPLE SCLEROSIS (REDEFINE-MS)
Washington University School of Medicine
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.
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 microgli…
Eligibility
- Age range
- 40–70 years
- Sex
- All
- 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, includ…
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.
Location
- Washington University School of Medicine in St. LouisSt Louis, Missouri