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NOT YET RECRUITING
NCT07647952
NA

PRIMUS : Real World Usage for Real World Evidence of CDSS Use in Multiple Sclerosis

Sponsor: Nantes University Hospital

View on ClinicalTrials.gov

Summary

This study evaluates a Clinical Decision Support System (CDSS), named PRIMUS, designed to support therapeutic decision-making in MS. The CDSS is based on a validated reference database integrating retrospective data from randomized controlled trials and the French national MS cohort (Observatoire Français de la Sclérose en Plaques, OFSEP). This reference database consists of synthetic data derived from these sources. PRIMUS enables visualization of disease activity at 1 and 2 years under different therapeutic scenarios, based on clinical and MRI characteristics of patients similar to the patient of interest. The CDSS PRIMUS aims to support informed and individualized treatment decisions. Because MRI is a critical marker of disease activity previously acquired MRI scans will be reanalyzed using automated segmentation and validated by a radiologist to standardize lesion assessment across centers. The results will be displayed to the neurologist and, if appropriate shown to the patient using a dedicated viewer, and can be discussed during the consultation. A cluster-randomized controlled trial, with hospitals as the unit, will be conducted to evaluate the impact of the CDSS on treatment decision-making in patients with relapsing-remitting MS. The primary objective is to assess whether the use of the CDSS influences therapeutic choices during clinical consultations. The study hypothesis is that use of the CDSS will increase the proportion of high-efficacy treatments initiated or selected, compared with usual care without CDSS support. In parallel, an optional sub-study using a mixed-methods approach will explore clinicians' and patients' perceptions of, and interactions with, the CDSS.

Official title: PRIMUS a Multi-centre, Controlled, Cluster-randomised, Open Study of Multiple Impacts of CDSS Use in Multiple Sclerosis : Real World Usage for Real World Evidence

Key Details

Gender

All

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

448

Start Date

2026-06-30

Completion Date

2028-07-31

Last Updated

2026-06-15

Healthy Volunteers

No

Interventions

DEVICE

Clinical decision support system

The Clinical Decision Support System (CDSS) PRIMUS is a software (as medical device) designed to support therapeutic decisions in multiple sclerosis (MS) and assist clinicians during consultations in which initiation or modification of MS treatment is considered. The system uses retrospective clinical and MRI data from a reference database to generate visualizations of disease evolution over a 2-year period under different therapeutic scenarios, based on patient-specific characteristics entered by the clinician. PRIMUS does not make treatment recommendations and does not replace clinical judgment. All treatment decisions remain at the discretion of the clinician

Locations (31)

Angers Hospital

Angers, France

Antibes Hospital

Antibes, France

Bordeaux Hospital

Bordeaux, France

CHU Brest

Brest, France

Caen Hospital

Caen, France

Clermont-Ferrand Hospital

Clermont-Ferrand, France

CHU Colmar

Colmar, France

Hôpital Henri Mondor

Créteil, France

Dijon Hospital

Dijon, France

Hôpital Emile Durkheim Epinal

Épinal, France

Grenoble Alpes Hospital

Grenoble, France

CHD Vendee

La Roche-sur-Yon, France

Lille Hospital

Lille, France

Hospices civils de Lyon

Lyon, France

Marseille Hospital / La Timone

Marseille, France

CHR Metz-Thionville / Mercy Hospital

Metz, France

Montpellier Hospital

Montpellier, France

Nancy Hospital

Nancy, France

Nice Hospital

Nice, France

Nimes Hospital

Nîmes, France

Hopital Fondation ROTSCHILD

Paris, France

CHIC Poissy

Poissy, France

Poitiers Hospital

Poitiers, France

Rennes Hospital

Rennes, France

Rouen Hospital

Rouen, France

Saint-Brieuc Hospital

Saint-Brieuc, France

Groupement Hospitalier Rance Emeraude Saint Malo

St-Malo, France

Strasbourg Hospital

Strasbourg, France

Toulouse Hospital

Toulouse, France

tours Hospital

Tours, France

Groupement Hospitalier Brocéliande Atlantique Vannes

Vannes, France