Montpellier PROspective Cohort in Relapsing Remitting Multiple Sclerosis Using Imaging and Serologic
PROMISE
1 other identifier
interventional
400
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable multiple-sclerosis
Started Sep 2023
Longer than P75 for not_applicable multiple-sclerosis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 15, 2023
CompletedFirst Posted
Study publicly available on registry
July 27, 2023
CompletedStudy Start
First participant enrolled
September 11, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2030
September 16, 2025
September 1, 2025
6.7 years
June 15, 2023
September 9, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total brain atrophy
Total brain atrophy measured with T1 MRI scans
3 years after Day 1
Secondary Outcomes (30)
Quantitative analysis: analysis of FLAIR hypersignals number
3 years after Day 1
Quantitative analysis: analysis of FLAIR hypersignals volume
3 years after Day 1
Qualitative analysis: analysis of central vein lesions
3 years after Day 1
Qualitative analysis: analysis of peripheral rim lesion
3 years after Day 1
Quantitative analysis: measurement of mean diffusivity
3 years after Day 1
- +25 more secondary outcomes
Study Arms (3)
Relapsing-remitting Multiple sclerosis benefiting from a moderately effective treatment
EXPERIMENTALModerately effective treatment includes interferon beta, glatiramer acetate, Teriflunomide, dimethyl Fumarate and monomethyl fumarate n= 175 patients
Relapsing-remitting Multiple sclerosis benefiting from a highly effective treatment
EXPERIMENTALHighly effective treatment includes Natalizumab, Ocrelizumab, Rituximab, Ofatumumab, Fingolimod and Cladribine n= 175 patients
Untreated relapsing-remitting Multiple sclerosis
EXPERIMENTALPatients untreated for relapsing-remitting Multiple sclerosis n= 50 patients
Interventions
Magnetic Resonance Imaging
Blood withdrawal
Neuropsychological tests
Eligibility Criteria
You may qualify if:
- Patients over 18 and under 60 years of age
- Patients with Relapsing-remitting MS without relapse for at least 6 months
You may not qualify if:
- Evidence of disease progression (clinical or radiological)
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Neurology Department, Hopital Gui de Chauliac
Montpellier, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 15, 2023
First Posted
July 27, 2023
Study Start
September 11, 2023
Primary Completion (Estimated)
June 1, 2030
Study Completion (Estimated)
June 1, 2030
Last Updated
September 16, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share