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

Официальное название

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

Обзор

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.

Вмешательства

• Устройство 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

Первичные конечные точки

• Treatment choice [Срок оценки: once at Month 1]

Вторичные конечные точки (12)

• Treatment decision concordance with expert recommendation [Срок оценки: Month 1]
• Patient Adherence: Concordance Between Prescribed and Actual Treatment [Срок оценки: Month 10, last visit]
• Treatment Decision Concordance with Dynamic Score Recommendation [Срок оценки: Month 1]
• Evolution of treatment decision [Срок оценки: Month 1]
• Cost-utility analysis of CDSS use [Срок оценки: Month 0 to Month 10]
• Patient-Reported Outcomes: Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) Score [Срок оценки: Month 0 and Month 10]
• Patient-Reported Outcomes: Health-Related Quality of life : 12-Item Short Form Health Survey (SF-12) Score [Срок оценки: Month 0 and Month 10]
• Clinician-Reported Usability of the Clinical Decision Support System (CDSS) [Срок оценки: Month 1]
• Patient experience with CDSS use Patient Experience with Clinical Decision Support System (CDSS) Use [Срок оценки: Month 1]
• Neurologist Experience with MRI Viewer Use During Consultation [Срок оценки: Month 1]
• Patient Experience with MRI Viewer Use During Consultation [Срок оценки: Month 1]
• Consultation duration [Срок оценки: Month 1]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 31 центр

• Angers Hospital — Angers
• Antibes Hospital — Antibes
• Bordeaux Hospital — Bordeaux
• CHU Brest — Brest
• Caen Hospital — Caen
• Clermont-Ferrand Hospital — Clermont-Ferrand
• CHU Colmar — Colmar
• Hôpital Henri Mondor — Créteil
• … и ещё 23 центра

Идентификаторы

NCT: NCT07647952 · RC22_0577 · 2026-A00510-51

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗