An observational study in Multiple Sclerosis (MS) - Relapsing-remitting, sponsored by Washington University School of Medicine. Recruiting at 1 site in United States. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-08-11.
Sponsored by Washington University School of Medicine · Observational
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.
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.
618 studies on the registry are indexed under Multiple Sclerosis, Relapsing-Remitting; 82 are open to participants now.
This study's planned enrollment of 15 is below the median of 120 across 157 observational studies indexed under Multiple Sclerosis, Relapsing-Remitting.
Browse Multiple Sclerosis, Relapsing-Remitting studies →Washington University School of Medicine is the lead sponsor of 1,803 studies on the registry; 271 are open to participants now.
Of its 329 completed or terminated interventional studies of FDA-regulated products, 216 (66%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants randomized to remibrutinib in the parent RESHAPE-MS study.
Drug: Remibrutinib
Participants randomized to ocrelizumab in the parent RESHAPE-MS study.
Drug: Ocrelizumab (US)
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.
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.
Change in Microglial Activity Measured by [11C]-DPA-713 PET
Change in regional \[11C\]-DPA-713 PET distribution volume ratio (DVR) from baseline to 6 months, comparing participants receiving remibrutinib with those receiving ocrelizumab.
Time frame: Baseline and 6 months after randomization
Start is estimated for Aug 2026; primary completion for Aug 2029, 36 months later.
Of 41 non-industry observational studies under Multiple Sclerosis, Relapsing-Remitting, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 56. This study's planned 36 months is below that.
Counting every sponsor, half of 67 studies reached it within 41 months; a quarter within 23 and three quarters within 55.
How these figures are worked out, and which studies are left out of them.
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Multiple Sclerosis, Relapsing-Remitting →
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