Brain Imaging and Immune Changes During Remibrutinib Treatment in Multiple Sclerosis.
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40-70
SponsorWashington University School of Medicine
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Remibrutinib
- Ocrelizumab (US)
Treatment groups
15 Participants
are divided into 2 treatment groupsSponsors and collaborators
Washington University School of Medicine
Lead sponsor
Novartis
Collaborator
Source ClinicalTrials.gov