Montpellier PROspective Cohort in Relapsing Remitting Multiple Sclerosis Using Imaging and Serologic

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 59
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Neurology Department, Hopital Gui de Chauliac
RECRUITING
Montpellier
Contact Information
Primary
Xavier AYRIGNAC, Medical Doctor
x-ayrignac@chu-montpellier.fr
0467337202
Time Frame
Start Date: 2023-09-11
Estimated Completion Date: 2030-06
Participants
Target number of participants: 400
Treatments
Experimental: Relapsing-remitting Multiple sclerosis benefiting from a moderately effective treatment
Moderately effective treatment includes interferon beta, glatiramer acetate, Teriflunomide, dimethyl Fumarate and monomethyl fumarate n= 175 patients
Experimental: Relapsing-remitting Multiple sclerosis benefiting from a highly effective treatment
Highly effective treatment includes Natalizumab, Ocrelizumab, Rituximab, Ofatumumab, Fingolimod and Cladribine n= 175 patients
Experimental: Untreated relapsing-remitting Multiple sclerosis
Patients untreated for relapsing-remitting Multiple sclerosis n= 50 patients
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Montpellier

This content was sourced from clinicaltrials.gov