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

2026年6月9日 更新者：Nantes University Hospital

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

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.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

448

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 法国
      • Angers、法国、49933
      • Antibes、法国、06606
      • Bordeaux、法国、33076
      • Brest、法国、29609
      • Caen、法国、14000
        • Caen Hospital
        • 接触：
      • Clermont-Ferrand、法国
      • Colmar、法国
      • Créteil、法国、94000
        • Hopital Henri Mondor
        • 接触：
      • Dijon、法国、21079
      • Grenoble、法国、38700
        • Grenoble Alpes Hospital
        • 接触：
      • La Roche-sur-Yon、法国、85925
      • Lille、法国、59037
      • Lyon、法国、69500
        • Hospices Civils de Lyon
        • 接触：
        • 首席研究员：
          • Sandra Mrs VUKUSIC, Professor
      • Marseille、法国、13385
        • Marseille Hospital / La Timone
        • 接触：
      • Metz、法国、57530
      • Montpellier、法国、34295
        • Montpellier Hospital
        • 接触：
      • Nancy、法国、54035
        • NANCY HOSPITAL
        • 接触：
        • 首席研究员：
          • Guillaume M MATHEY, PHD
      • Nice、法国、06000
        • Nice Hospital
        • 接触：
          • Christine Mrs LEBRUN-FRENAY, Professor
          • 电话号码：04 92 03 85 27
          • 邮箱：lebrun.c@chu-nice.fr
        • 首席研究员：
          • Christine Mrs LEBRUN-FRENAY, Professor
      • Nîmes、法国、30029
      • Paris、法国、75019
        • Hopital Fondation ROTSCHILD
      • Poissy、法国、78303
      • Poitiers、法国、86021
        • Poitiers Hospital
        • 接触：
        • 首席研究员：
          • Amélie Mrs DOS SANTOS, PHD
      • Rennes、法国、35000
        • Rennes Hospital
        • 接触：
        • 首席研究员：
          • Laure Michel, Professor
      • Rouen、法国、76000
        • Rouen Hospital
        • 接触：
        • 首席研究员：
          • Bertrand BOURRE, Professor
      • Saint-Brieuc、法国、22027
        • Saint-Brieuc Hospital
        • 接触：
        • 首席研究员：
          • François M LALLEMENT, PHD
      • St-Malo、法国
        • Groupement Hospitalier Rance Emeraude Saint Malo
        • 接触：
      • Strasbourg、法国、67200
        • Strasbourg hospital
        • 接触：
        • 首席研究员：
          • Jerome M DE SEZE, Professor
      • Toulouse、法国、31059
        • Toulouse Hospital
        • 接触：
        • 首席研究员：
          • Jonathan M CIRON, PHD
      • Tours、法国、37044
      • Vannes、法国、56017
        • Groupement Hospitalier Brocéliande Atlantique Vannes
        • 接触：
      • Épinal、法国、88000

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

不

描述

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 recommendations of the Clinical Trials Coordination Group

Exclusion Criteria:

  • 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).

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：其他
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Consultation with clinical decision support system CDSS
Participants will undergo a consultation supported by a CDSS when initiation or modification of MS treatment is being considered.
设备：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
无干预：Usual care (consultation without CDSS)
Participants 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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Treatment choice
大体时间：once at Month 1
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

次要结果测量

结果测量
措施说明
大体时间
Treatment decision concordance with expert recommendation
大体时间：Month 1
Assessment of concordance defined as agreement (Yes/no) between the treatment decision made by the neurologist at the end of the consultation (Month 1, with or without CDSS use) and the treatment decision recommended by an independent expert panel of experts.
Month 1
Patient Adherence: Concordance Between Prescribed and Actual Treatment
大体时间：Month 10, last visit
Assessment of concordance (yes/no) between the treatment decision made by the neurologist at the end of the consultation (Month 1, with or without CDSS use) and the treatment actually taken by the patient at Month 10.
Month 10, last visit
Treatment Decision Concordance with Dynamic Score Recommendation
大体时间：Month 1
Assessment of concordance defined as agreement (yes/no) between the treatment decision made by the neurologist at the end of the consultation (M1, with or without CDSS use) and recommendations derived from a dynamic scoring system designed to guide early switching from first-line to second-line disease-modifying therapy in patients with relapsing-remitting MS.For this outcome measure, results will be reported as the proportion of participants whose treatment decision is concordant with the recommendation generated by the dynamic score (Yes/No).The dynamic score is based on predefined clinical and radiological criteria and identifies patients who may benefit from early treatment escalation to reduce the risk of relapse.The recommendation generated by the score (maintain first-line therapy or escalate to second-line therapy) will be compared to the neurologist's treatment decision.Concordance will be considered achieved if the neurologist's treatment decision matches the recommendations
Month 1
Evolution of treatment decision
大体时间：Month 1

Assessment of concordance defined as agreement (yes/no) between the treatment decision initially considered by the neurologist at inclusion (Month 0) and the treatment decision made at the end of the consultation (Month 1, with or without CDSS use).

This outcome evaluates whether the initial treatment strategy is maintained or modified between Month 0 and Month 1, including potential influence of CDSS use during the consultation
Month 1
Cost-utility analysis of CDSS use
大体时间：Month 0 to Month 10

A cost-utility analysis will be conducted from a societal perspective over a 10-month period : at baseline (Month 0), Month 1, and Month 10 to evaluate the impact of CDSS use.

Health-related quality of life will be assessed using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L). The EQ-5D-5L descriptive system includes five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each with five response levels.

Utility index values range from values below 0 (health states worse than death) to 1 (perfect health), with higher scores indicating better health status.

Costs related to multiple sclerosis care will be collected over the study period (M0-M10) using patient diaries. Quality-adjusted life years (QALYs) will be estimated from EQ-5D-5L utility values and combined with cost data to perform the cost-utility analysis.
Month 0 to Month 10
Patient-Reported Outcomes: Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) Score
大体时间：Month 0 and Month 10

Health-related quality of life will be assessed using validated patient-reported outcome (PRO) instrument : the Multiple Sclerosis-specific quality of life questionnaire (MusiQoL) at baseline (Month 0) and Month 10.

The MusiQoL provides a disease-specific assessment of quality of life in multiple sclerosis. The MusiQoL global index score ranges from 0 to 100.

Higher scores indicate better health-related quality of life.
Month 0 and Month 10
Patient-Reported Outcomes: Health-Related Quality of life : 12-Item Short Form Health Survey (SF-12) Score
大体时间：Month 0 and Month 10

General health-related quality of life will be assessed using the 12-Item Short Form Health Survey (SF-12) at baseline (Month 0) and Month 10. It evaluates general health-related quality of life.

The SF-12 generates Physical Component Summary (PCS) and Mental Component Summary (MCS) scores. Scores generally range from 0 to 100.

Higher scores indicate better health-related quality of life.
Month 0 and Month 10
Clinician-Reported Usability of the Clinical Decision Support System (CDSS)
大体时间：Month 1

In the CDSS arm only, patient experience will be assessed using a dedicated 10-item questionnaire administered after a consultation supported by the Clinical Decision Support System (CDSS) at Month 1.

Each item is rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). The total score ranges from 10 to 50, with higher scores indicating a better patient experience with the CDSS-supported consultation.
Month 1
Patient experience with CDSS use Patient Experience with Clinical Decision Support System (CDSS) Use
大体时间：Month 1

In the CDSS arm only, patient experience will be assessed using a dedicated 10-item questionnaire administered after a consultation supported by the Clinical Decision Support System (CDSS) at Month 1.

Each item is rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). The total score ranges from 10 to 50, with higher scores indicating a better patient experience with the CDSS-supported consultation.
Month 1
Neurologist Experience with MRI Viewer Use During Consultation
大体时间：Month 1

Neurologists' experience with MRI viewer use during consultation will be assessed in both study arms (with or without CDSS use).

Experience will be assessed using a dedicated 10-item questionnaire rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). The total score ranges from 10 to 50, with higher scores indicating greater satisfaction and perceived usability of MRI visualization. All participating neurologists will complete the questionnaire.
Month 1
Patient Experience with MRI Viewer Use During Consultation
大体时间：Month 1

Patient experience regarding MRI visualization using the viewer during neurological consultation will be assessed in both study arms.

Experience will be assessed using a dedicated 10-item questionnaire rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). The total score ranges from 10 to 50, with higher scores indicating greater satisfaction and improved understanding of MRI information. All included patients will complete the questionnaire.
Month 1
Consultation duration
大体时间：Month 1
Impact of the (CDSS) on the duration of the neurological consultation. Consultation duration will be defined as the time (in minutes) elapsed between the start and end of the consultation (in minutes) at Month 1, conducted either with or without CDSS support
Month 1
Device reliability
大体时间：Month 1

Reliability of the Clinical Decision Support System (CDSS) will be assessed by recording the number of device-related issues occurring during the study period. These issues include system failures, software bugs, interface malfunctions, security issues, interpretation errors, performance degradation, and connectivity problems.

All CDSS-related malfunctions or operational issues will be recorded
Month 1

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Nantes University Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年6月30日

初级完成 (估计的)

2027年10月31日

研究完成 (估计的)

2028年7月31日

研究注册日期

首次提交

2026年6月2日

首先提交符合 QC 标准的

2026年6月9日

首次发布 (实际的)

2026年6月15日

研究记录更新

最后更新发布 (实际的)

2026年6月15日

上次提交的符合 QC 标准的更新

2026年6月9日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • RC22_0577
  • 2026-A00510-51 (其他标识符：Nantes Hospital)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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