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

Starting soon · Not applicable

Conditions studied: Relapsing - Remitting Multiple Sclerosis

In brief

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.

Key facts

Study ID: NCT07647952
Run by: Nantes University Hospital
People needed: 448
Starts: 2026-06-30
Expected to finish: 2028-07-31
Last updated by the study team: 2026-06-15

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Men and women aged >18 and ≤50 years.
Patients with relapsing-remitting multiple sclerosis (RRMS) according to the McDonald 2024 criteria.
Patients for whom a change in therapeutic management is being considered due to:
intolerance to treatment or personal preference in the absence of inflammatory activity, whether patients are:
on a moderately effective disease-modifying therapy [Interferon beta; Glatiramer acetate; Teriflunomide; Dimethyl fumarate; Diroximel fumarate] for at least 12 months without interruption
on anti-S1P therapy [Fingolimod; Ponesimod] for at least 12 months without interruption or
recent inflammatory activity (relapse or at least one T1 Gd+ lesion or one new T2 lesion) reported or observed at inclusion, whether patients are:
treatment-naïve
on a moderately effective disease-modifying therapy for at least 6 months or on anti-S1P therapy for at least 6 months
untreated for at least one year
Patients with MRI follow-up including at least one 3D brain FLAIR sequence and a T1 Gd+ sequence in the case of a re-baseline brain MRI within the past 6 months.
Patients whose MRI scans are available for download on the day of consultation.
Patients affiliated with or beneficiaries of a social security system.
Patients able to provide written informed consent. For women of childbearing potential, use of an effective method of contraception throughout the study in accordance with the recommendations of the Clinical Trials Coordination Group

You may not qualify if…

Patients with a progressive form of multiple sclerosis (primary or secondary).
Patients with current or past history of other autoimmune diseases.
Patients with uncontrolled disease, other than active MS.
Patients exposed to Mitoxantrone, Alemtuzumab, or Cladribine within the 3 years prior to inclusion.
Patients exposed to Ocrelizumab or Rituximab within the 18 months prior to inclusion.
Patients exposed to Ofatumumab within the 12 months prior to inclusion.
Patients receiving high-efficacy disease-modifying therapy [Natalizumab; Ofatumumab; Alemtuzumab; Cladribine; Mitoxantrone; Ocrelizumab], or Rituximab, with the exception of S1P receptor modulators.
Patients receiving Mycophenolate mofetil, azathioprine, cyclophosphamide (Endoxan), or having undergone stem cell transplantation.
Patients participating in another clinical trial, whether therapeutic or not, that could interfere with the objectives of the study.
Patients who have participated in a therapeutic trial within the 24 months prior to inclusion.
Pregnant or breastfeeding women, or those planning pregnancy during the study.
Patients under legal protection (guardianship, curatorship, or other protective measures).

Where it is running

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

Full record on ClinicalTrials.gov

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