Recruiting NCT05962177

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

No phase Interventional Multiple Sclerosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Magnetic Resonance Imaging, Blood withdrawal, Neuropsychological tests.
Who it may be relevant to: Registry conditions: Multiple Sclerosis. Basic parameters: 18 years — 59 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: France
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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).

Detailed description

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).

3 groups of interest will be studied and included in the study:

* Group 1: RRMS with medium efficacy treatment (interferon beta, glatiramer acetate, Teriflunomide, dimethyl fumarate, monomethyl fumarate) of the disease (n=175 patients) * Group 2: RRMS with high efficacy treatment (Natalizumab, Ocrelizumab, Rituximab, Ofatumumab, Fingolimod, Cladribine: n=175 patients) * Group 3: Untreated RRMS (n=50 patients)

Interventions

Other Magnetic Resonance Imaging
Magnetic Resonance Imaging
Other Blood withdrawal
Blood withdrawal
Other Neuropsychological tests
Neuropsychological tests

Primary outcome measures

Total brain atrophy [Time frame: 3 years after Day 1]

Secondary outcome measures (12)

Quantitative analysis: analysis of FLAIR hypersignals number [Time frame: 3 years after Day 1]
Quantitative analysis: analysis of FLAIR hypersignals volume [Time frame: 3 years after Day 1]
Qualitative analysis: analysis of central vein lesions [Time frame: 3 years after Day 1]
Qualitative analysis: analysis of peripheral rim lesion [Time frame: 3 years after Day 1]
Quantitative analysis: measurement of mean diffusivity [Time frame: 3 years after Day 1]
Quantitative analysis: measurement of anisotropy fraction [Time frame: 3 years after Day 1]
Quantitative analysis: measurement of cerebral blood flow (CBF) [Time frame: 3 years after Day 1]
Changes in serum light chain neurofilament values [Time frame: 3 years after Day 1]
Clinical assessment scale: relapses [Time frame: 3 years after Day 1]
Clinical assessment scale: Expanded Disability Status Scale (EDSS) [Time frame: 3 years after Day 1]
Clinical assessment scale: Computerized Speed Cognitive Test (CSCT) [Time frame: 3 years after Day 1]
Clinical assessment scale: Six-Minute Walk Test (6MWT) [Time frame: 3 years after Day 1]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Non-randomized
Model: Single group
Masking: Open label
Primary purpose: Other

Study locations

France · 1 center

Neurology Department, Hopital Gui de Chauliac — Montpellier

Identifiers

NCT: NCT05962177 · RECHMPL20_0422

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗