Understanding inflammation in relapsing remitting Multiple Sclerosis
Investigation of Smoldering Inflammation in Multiple Sclerosis
Washington University School of Medicine · NCT06591429
This study looks at the type of inflammation in people with relapsing remitting Multiple Sclerosis to see why some inflammation sticks around even after treatment and how this might help improve future therapies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Washington University School of Medicine (other) |
| Drugs / interventions | ocrelizumab, natalizumab, radiation |
| Locations | 1 site (St Louis, Missouri) |
| Trial ID | NCT06591429 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the nature of inflammation in patients with relapsing remitting Multiple Sclerosis (MS) using advanced imaging techniques and cerebrospinal fluid analysis. It seeks to compare abnormal neural inflammation with cellular and molecular inflammation, particularly focusing on why some inflammation persists even after treatment with high-efficacy disease-modifying therapies (DMTs). By identifying components of inflammation that do not resolve with current therapies, the study hopes to inform future treatment strategies targeting these persistent inflammatory processes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a diagnosis of active relapsing remitting Multiple Sclerosis who are treatment naïve except for relapse-related treatments.
Not a fit: Patients with stable MS who do not have active disease or those who have previously received high-efficacy DMTs may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new therapies that address the underlying causes of disability in MS patients.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in understanding inflammation in MS, but the specific focus on smoldering inflammation is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female, any race * Age ≥ 18 years * Capable of providing written informed consent for volunteering to undergo research procedures * Diagnosis of MS as established by the referring physician and confirmed by the Sponsor-Investigator. Only patients with active disease, defined as at least 1 enhancing lesion present in the preceding 6 months, will be enrolled * Treatment naïve except for relapse-related treatments such as corticosteroids or plasmapheresis, * Planned initiation, at the discretion of the referring physician, of a high efficacy DMT. High efficacy DMT will be defined to include ocrelizumab, natalizumab, or any MS treatment in the opinion of the Sponsor-Investigator to have similar efficacy as the named treatments * Clinical labs, including at least a CBC and BMP, without significant abnormality as determined by the Sponsor-Investigator or designee, within the 3 months prior to enrollment Exclusion Criteria: * Presence of a low binding polymorphism for TSPO * Hypersensitivity to \[11C\]-CS1P1, \[11C\]-DPA-713, \[18F\]-FDG, or any of their excipients * Contraindications to PET, CT 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 * eGFR less than 60 (for gadolinium) * Severe claustrophobia * Women who are currently pregnant or breast-feeding * Currently undergoing radiation therapy * Insulin dependent diabetes * Contraindication to lumbar puncture (LP), including use of antiplatelet therapy (other than aspirin 81mg), therapeutic anticoagulation, or space occupying intracranial mass. History of a coagulopathy is also exclusionary * Any condition that, in the opinion of the Sponsor-Investigator or designee could increase risk to the participant, limit the participant's ability to tolerate the research procedures or interfere with collection of the data (e.g., renal or liver failure, 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 5 rem
Where this trial is running
St Louis, Missouri
- Barnes Jewish Center for Clinical Imaging Research — St Louis, Missouri, United States (RECRUITING)
Study contacts
- Study coordinator: Matthew Brier, MD, PhD
- Email: brierm@wustl.edu
- Phone: 314-362-7666
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Multiple Sclerosis, Imaging, Inflammation