Montpellier PROspective Cohort in Relapsing Remitting Multiple Scleros
Montpellier PROspective Cohort in Relapsing Remitting Multiple Sclerosis Using Imaging and Serologic
What it found
No result yet.
What was tested
Treatment tested
- Magnetic Resonance Imaging
- Blood withdrawal
- Neuropsychological tests
What it measured
Main measures
Total brain atrophy
3 years after Day 1
MRI lesionsBrain volume loss
Other measures (30)
Quantitative analysis: analysis of FLAIR hypersignals number
3 years after Day 1
MRI lesionsQuantitative analysis: analysis of FLAIR hypersignals volume
3 years after Day 1
Qualitative analysis: analysis of central vein lesions
3 years after Day 1
MRI lesionsQualitative analysis: analysis of peripheral rim lesion
3 years after Day 1
MRI lesionsSmouldering inflammationQuantitative analysis: measurement of mean diffusivity
3 years after Day 1
MRI lesionsQuantitative analysis: measurement of anisotropy fraction
3 years after Day 1
MRI lesionsQuantitative analysis: measurement of cerebral blood flow (CBF)
3 years after Day 1
Changes in serum light chain neurofilament values
3 years after Day 1
Blood or spinal fluid markersClinical assessment scale: relapses
3 years after Day 1
RelapsesClinical assessment scale: Expanded Disability Status Scale (EDSS)
3 years after Day 1
Disability progression
Who could take part
Relapsing MS · 18 to 59
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
Contact details on the registryAbout this trial
In the sponsor's words
Several prospective monocentric cohorts of between 250 and 1000 patients have been set up in order to characterize more precisely the evolution of the disease. Nevertheless, due to an initial recruitment carried out in the years 2000-2010, they do not constitute a faithful representation of the patients followed in clinical routine, in particular in terms of distribution of treatments. Indeed, the introduction, about 10 years ago, of high efficacy treatments (HET) has changed the management of the disease and a significant proportion of patients not controlled by medium efficacy treatments (MET) of the disease are now stable on HET. Nevertheless, if their short-term efficacy has been clearly demonstrated, it remains important to be able to confirm the superiority of HET over MET with the help of prospective cohorts (thus ensuring a retention of patients > 90% over the long term) analyzing all clinical and imaging biomarkers, imaging and biological data. The measurement of cerebral atrophy and its progression is probably one of the most interesting and most easily used biomarkers that can be used clinically to assess this silent progression in these groups of patients. The progression of brain atrophy is also dependent on many other non-modifiable but also modifiable factors outside of MS that need to be better evaluated and eventually managed. Nevertheless, the existence of various neurological comorbidities (sleep disorders, headaches) on this atrophy has not been specifically analyzed to date. The functional assessments used in routine follow-up are most often performed in a care facility and have many limitations: lack of reproducibility, inter/intra operator variability, poor correlation with functional and quality of life scales, etc. It is therefore extremely important to be able to identify new clinical biomarkers of disease progression of the disease by evaluating the physical capacities of the patients as precisely as possible. This study is a single-center, prospective cohort study of a population of 400 patients with relapsing remitting MS (RRMS). The main objective of this study is to compare, on morphological imaging criteria (T1 volumetry), the progression of brain atrophy (biomarker of disease progression) at 3 years in RRMS patients according to treatment line (MET vs HET).
Papers
Loading reviews and guidelines…
History
Started
Sept 2023
Main results due
Jun 2030
Finished
Jun 2030