PRIMUS : Real World Usage for Real World Evidence of CDSS Use in Multiple Sclerosis (NCT07647952) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
PRIMUS : Real World Usage for Real World Evidence of CDSS Use in Multiple Sclerosis
France448 participantsStarted 2026-06-30
Plain-language 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.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 recomm…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.