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

2026년 6월 9일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

448

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인

건강한 자원 봉사자를 받아들입니다

아니

설명

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).

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 다른
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
장치: 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
간섭 없음: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Treatment choice
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Treatment decision concordance with expert recommendation
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Nantes University Hospital

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 6월 30일

기본 완료 (추정된)

2027년 10월 31일

연구 완료 (추정된)

2028년 7월 31일

연구 등록 날짜

최초 제출

2026년 6월 2일

QC 기준을 충족하는 최초 제출

2026년 6월 9일

처음 게시됨 (실제)

2026년 6월 15일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 15일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 9일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • RC22_0577
  • 2026-A00510-51 (기타 식별자: Nantes Hospital)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

Relapsing - Remitting Multiple Sclerosis에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

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CROs in Canada

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다