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.
• 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.