No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
40 – 70
Sex
Any
Study type
Observational
Participants needed
15 (estimated)
Sponsor
Washington University School of Medicine · Other
Who this trial is looking for
This trial is looking for people with relapsing multiple sclerosis who have been on a treatment called ocrelizumab. Participants will undergo brain scans and provide blood and spinal fluid samples before starting remibrutinib and again six months later to see how it affects inflammation.
Are You a Good Fit for This Trial?
Must be takingOcrelizumab
You may be able to join if
I can give written consent for research procedures
I am between 40 and 70 years old
I have been diagnosed with relapsing multiple sclerosis
My EDSS score is between 0 and 6.5
I have been treated with ocrelizumab for at least 18 months
I had my last ocrelizumab dose 5 to 9 months before joining
I have been neurologically stable for 30 days before screening
My doctor thinks I can switch to remibrutinib
You may not be able to join if
I am allergic to certain imaging substances
I have conditions that make participation unsafe
I have recently participated in other studies with radioactive agents
I cannot lie still for a long time
I have advanced cancer
I have liver or kidney disease
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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…
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.
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Eligibility Criteria
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 (inc…
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 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:
* 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)
* Current or recent (within 12 months prior to screening) participation in research studies involving radioactive agents such that the total research-related radiation dose to the participant in any given year would exceed the limits set forth in the U.S. Code of Federal Regulations (CFR) Title 21 Section 361.1. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=361.1.
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