Cohort study on relapsing-remitting multiple sclerosis using imaging and blood tests
Montpellier PROspective Cohort in Relapsing Remitting Multiple Sclerosis Using Imaging and Serologic
This study is trying to see if stronger treatments for relapsing-remitting multiple sclerosis work better than medium-strength treatments by looking at patients' brain scans and blood tests over time.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years to 59 Years |
| Sex | All |
| Sponsor | University Hospital, Montpellier Academic / other |
| Drugs / interventions | Natalizumab, Ocrelizumab, Rituximab, Ofatumumab |
| Locations | 1 site (Montpellier) |
| Trial ID | NCT05962177 on ClinicalTrials.gov |
What this trial studies
This study aims to establish a prospective cohort of patients with relapsing-remitting multiple sclerosis (RRMS) to better understand the disease's evolution and the effectiveness of high efficacy treatments (HET) compared to medium efficacy treatments (MET). By recruiting patients aged 18 to 55 who have not experienced a relapse for at least six months, the study will utilize magnetic resonance imaging (MRI), blood tests, and neuropsychological assessments to gather comprehensive clinical and imaging data. The goal is to confirm the long-term superiority of HET over MET while ensuring a high retention rate of participants. This research will also explore the relationship between brain atrophy and various factors affecting disease progression.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 55 with relapsing-remitting MS who have been stable without a relapse for at least six months.
Not a fit: Patients with secondary or primary progressive MS, recent treatment changes, or contraindications to MRI may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the most effective treatment strategies for managing relapsing-remitting multiple sclerosis.
How similar studies have performed: Other studies have shown success in using similar cohort approaches to evaluate treatment efficacy in multiple sclerosis, making this study a continuation of established research methodologies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients over 18 and under 60 years of age * Patients with Relapsing-remitting MS without relapse for at least 6 months * EDSS\<6 at time of inclusion Exclusion Criteria: * Secondary progressive MS or Primary progressive MS at time of inclusion * Evidence of disease progression (clinical or radiological) * Change in treatment within 6 months prior to inclusion * Subject with a contraindication to MRI (claustrophobia, pacemaker, etc.) * Inability to follow the follow-up planned by the study * Pregnant or breastfeeding women * Patient not affiliated to the social security system or not benefiting from such a system * Adult protected by law or patient under guardianship or curatorship * Failure to obtain written informed consent after a reflection period
Where this trial is running
Montpellier
- Neurology Department, Hopital Gui de Chauliac — Montpellier, France (Recruiting)
Study contacts
- Study coordinator: Xavier AYRIGNAC, Medical Doctor
- Email: x-ayrignac@chu-montpellier.fr
- Phone: 0467337202
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.