PRIMUS : Real World Usage for Real World Evidence of CDSS Use in Multiple Sclerosis
PRIMUS
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
2 other identifiers
interventional
448
1 country
31
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2026
Typical duration for not_applicable
31 active sites
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 2, 2026
CompletedFirst Posted
Study publicly available on registry
June 15, 2026
CompletedStudy Start
First participant enrolled
June 30, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2027
Study Completion
Last participant's last visit for all outcomes
July 31, 2028
June 15, 2026
June 1, 2026
1.3 years
June 2, 2026
June 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Treatment choice
Treatment decision at the end of the consultation with or without CDSS use. Patients will be classified into groups: high-efficacy disease-modifying therapies (anti-CD20 therapies, natalizumab, cladribine, S1P receptor modulators), moderate-efficacy therapies (interferon beta, dimethyl fumarate, teriflunomide), or no treatment. Results will be expressed as the percentage of patients in each category/ The distribution of treatment strategies will be expressed as the percentage of patients in each category.
once at Month 1
Secondary Outcomes (13)
Treatment decision concordance with expert recommendation
Month 1
Patient Adherence: Concordance Between Prescribed and Actual Treatment
Month 10, last visit
Treatment Decision Concordance with Dynamic Score Recommendation
Month 1
Evolution of treatment decision
Month 1
Cost-utility analysis of CDSS use
Month 0 to Month 10
- +8 more secondary outcomes
Study Arms (2)
Consultation with clinical decision support system CDSS
EXPERIMENTALParticipants will undergo a consultation supported by a CDSS when initiation or modification of MS treatment is being considered.
Usual care (consultation without CDSS)
NO INTERVENTIONParticipants will receive standard clinical care without the use of a Clinical Decision Support System (CDSS). Treatment decisions will be made according to routine clinical practice.
Interventions
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
Eligibility Criteria
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
- 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 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.
- Pregnant or breastfeeding women, or those planning pregnancy during the study.
- Patients under legal protection (guardianship, curatorship, or other protective measures).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
Angers Hospital
Angers, 49933, France
Antibes Hospital
Antibes, 06606, France
Bordeaux Hospital
Bordeaux, 33076, France
CHU Brest
Brest, 29609, France
Caen Hospital
Caen, 14000, France
Clermont-Ferrand Hospital
Clermont-Ferrand, France
CHU Colmar
Colmar, France
Hôpital Henri Mondor
Créteil, 94000, France
Dijon Hospital
Dijon, 21079, France
Hôpital Emile Durkheim Epinal
Épinal, 88000, France
Grenoble Alpes Hospital
Grenoble, 38700, France
CHD Vendee
La Roche-sur-Yon, 85925, France
Lille Hospital
Lille, 59037, France
Hospices civils de Lyon
Lyon, 69500, France
Marseille Hospital / La Timone
Marseille, 13385, France
CHR Metz-Thionville / Mercy Hospital
Metz, 57530, France
Montpellier Hospital
Montpellier, 34295, France
Nancy Hospital
Nancy, 54035, France
Nice Hospital
Nice, 06000, France
Nimes Hospital
Nîmes, 30029, France
Hopital Fondation ROTSCHILD
Paris, 75019, France
CHIC Poissy
Poissy, 78303, France
Poitiers Hospital
Poitiers, 86021, France
Rennes Hospital
Rennes, 35000, France
Rouen Hospital
Rouen, 76000, France
Saint-Brieuc Hospital
Saint-Brieuc, 22027, France
Groupement Hospitalier Rance Emeraude Saint Malo
St-Malo, France
Strasbourg Hospital
Strasbourg, 67200, France
Toulouse Hospital
Toulouse, 31059, France
tours Hospital
Tours, 37044, France
Groupement Hospitalier Brocéliande Atlantique Vannes
Vannes, 56017, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2026
First Posted
June 15, 2026
Study Start (Estimated)
June 30, 2026
Primary Completion (Estimated)
October 31, 2027
Study Completion (Estimated)
July 31, 2028
Last Updated
June 15, 2026
Record last verified: 2026-06