Relapsing - Remitting Multiple SclerosisPRIMUSNCT07647952
PRIMUS : Real World Usage for Real World Evidence of CDSS Use in Multiple Sclerosis
A study testing Clinical decision support system in people with Relapsing - Remitting Multiple Sclerosis, run by Nantes University Hospital at 31 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Relapsing - Remitting Multiple Sclerosis
- What is being tested?
- Clinical decision support system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 448 participants
- Where
- 31 sitesFrance
- Study dates
- 30 Jun 2026to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- 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.
Show all 12Show fewer
- 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).
Trial locations and contacts
31 sites in 1 country. Contact the study team or a site near you to ask about taking part.
31 sites in 1 country
France31 sites
Angers Hospital
Angers, 49933
Clarisse SCHERER-GAGOU, 02 41 35 56 15, clscherer@chu-angers.fr
Antibes Hospital
Antibes, 06606
Renato COLOMARINO, 04 97 24 77 25 / 82 15, renato.colamarino@ch-antibes.fr
Bordeaux Hospital
Bordeaux, 33076
Aurélie RUET, Pr, 05 56 79 55 21, aurelie.ruet@chu-bordeaux.fr
CHU Brest
Brest, 29609
Aurore JOURDAIN, 02 98 34 73 00, aurore.jourdain@chu-brest.fr
Caen Hospital
Caen, 14000
Pierre M BRANGER, PHD, 02 31 06 46 17, branger-p@chu-caen.fr
Clermont-Ferrand Hospital
Clermont-Ferrand
Pierre CLAVELOU, Pr, 04 73 75 22 01, pclavelou@chu-clermontferrand.fr
CHU Colmar
Colmar
François SELLAL, 03 89 12 41 50, francois.sellal@ch-colmar.fr
Hôpital Henri Mondor
Créteil, 94000
Alain M CREANGE, Professor, 01 49 81 23 15, alain.creange@aphp.fr
Dijon Hospital
Dijon, 21079
Thibault MOREAU, Pr, 03 80 29 52 70, thibault.moreau@chu-dijon.fr
Hôpital Emile Durkheim Epinal
Épinal, 88000
Thomas M Ancel, PHD, thomas.ancel@ch-ed.fr
Grenoble Alpes Hospital
Grenoble, 38700
Olivier M CASEZ, PH, 04 76 76 58 71, OCasez@chu-grenoble.fr
CHD Vendee
La Roche-sur-Yon, 85925
Pascal M LEJEUNE, PHD, 02 51 44 62 58, pascal.lejeune@ght85.fr
Lille Hospital
Lille, 59037
Hélène ZEPHIR, Professor, 03 20 44 57 65, helene.zephir@chu-lille.fr
Hospices civils de Lyon
Lyon, 69500
Sandra Mrs VUKUSIC, Professor, 04 72 68 13 13, sandra.vukusic@chu-lyon.fr
Sandra Mrs VUKUSIC, Professor
Marseille Hospital / La Timone
Marseille, 13385
Jean PELLETIER, 04 91 38 59 41, jean.PELLETIER@ap-hm.fr
CHR Metz-Thionville / Mercy Hospital
Metz, 57530
Basile M WITTWER, 03 87 18 61 62, basile.wittwer@chr-metz-thionville.fr
Montpellier Hospital
Montpellier, 34295
Pierre LABAUGE, Pr, 04 67 33 94 69, labauge@yahoo.fr
Nancy Hospital
Nancy, 54035
Guillaume M MATHEY, PHD, nk, g.mathey@chru-nancy.fr
Guillaume M MATHEY, PHD
Nice Hospital
Nice, 06000
Christine Mrs LEBRUN-FRENAY, Professor, 04 92 03 85 27, lebrun.c@chu-nice.fr
Christine Mrs LEBRUN-FRENAY, Professor
Nimes Hospital
Nîmes, 30029
Eric THOUVENOT, Pr, 04 66 68 32 61, eric.thouvenot@chu-nimes.fr
Hopital Fondation ROTSCHILD
Paris, 75019
CHIC Poissy
Poissy, 78303
Olivier HEINZLEF, PH, 01 39 27 41 92, olivier.heinzlef@ght-yvelinesnord.fr
Poitiers Hospital
Poitiers, 86021
Amélie Mrs DOS SANTOS, 0253482852, amelie.dos-santos@chu-poitiers.fr
Amélie Mrs DOS SANTOS, PHD
Rennes Hospital
Rennes, 35000
Laure Mrs Michel, Professor, 02 99 28 42 94, laure.michel@chu-rennes.fr
Laure Michel, Professor
Rouen Hospital
Rouen, 76000
Bertrand M BOURRE, Professor, +332 32 88 09 68, bertrand.bourre@chu-rouen.fr
Bertrand BOURRE, Professor
Saint-Brieuc Hospital
Saint-Brieuc, 22027
François M LALLEMENT, PHD, 02 96 01 75 00, francois.lallement@armorsante.bzh
François M LALLEMENT, PHD
Groupement Hospitalier Rance Emeraude Saint Malo
St-Malo
Kevin AHRWEILLER, PH, +332 99 21 65 71, k.ahrweiller@ch-stmalo.fr
Strasbourg Hospital
Strasbourg, 67200
Jerome M DE SEZE, Professor, 03 88 12 85 43, jerome.de.seze@chru-strasbourg.fr
Jerome M DE SEZE, Professor
Toulouse Hospital
Toulouse, 31059
Jonathan M CIRON, PHD, 05 61 77 91 06, ciron.j@chu-toulouse.fr
Jonathan M CIRON, PHD
tours Hospital
Tours, 37044
Inès DOGHRI, 02 47 47 80 23, i.doghri@chu-tours.fr
Groupement Hospitalier Brocéliande Atlantique Vannes
Vannes, 56017
Jeanne MARTIN, 02 97 01 41 52, jeanne.martin@ghba.fr
About this study
Official title: 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.
Read more
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.
- Conditions
- Relapsing - Remitting Multiple Sclerosis
- Being tested
- Clinical decision support system
- Keywords
- multiple sclerosis, CDSS
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical decision support systemDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Consultation with clinical decision support system CDSS | Experimental | Participants will undergo a consultation supported by a CDSS when initiation or modification of MS treatment is being considered. Receives: Device: Clinical decision support system |
| Usual care (consultation without CDSS) | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: once at Month 1
Secondary outcomes (13)
Treatment decision concordance with expert recommendation
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.
Measured: Month 1
Patient Adherence: Concordance Between Prescribed and Actual Treatment
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.
Measured: Month 10, last visit
Treatment Decision Concordance with Dynamic Score Recommendation
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
Measured: Month 1
Evolution of treatment decision
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
Measured: Month 1
Cost-utility analysis of CDSS use
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.
Measured: Month 0 to Month 10
Patient-Reported Outcomes: Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) Score
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.
Measured: Month 0 and Month 10
Patient-Reported Outcomes: Health-Related Quality of life : 12-Item Short Form Health Survey (SF-12) Score
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.
Measured: Month 0 and Month 10
Clinician-Reported Usability of the Clinical Decision Support System (CDSS)
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.
Measured: Month 1
Patient experience with CDSS use Patient Experience with Clinical Decision Support System (CDSS) Use
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.
Measured: Month 1
Neurologist Experience with MRI Viewer Use During Consultation
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.
Measured: Month 1
Patient Experience with MRI Viewer Use During Consultation
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.
Measured: Month 1
Consultation duration
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
Measured: Month 1
Device reliability
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
Measured: Month 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start30 Jun 2026 (estimated)
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing - Remitting Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study uses a cluster-randomized design with hospital (where the patient receives MS care) as cluster. Each center will be randomly allocated in a 1:1 ratio to experimental group (using CDSS/ use of the CDSS during the consultation), control group (receive usual care).The study is conducted in an open-label manner, with both patients and treating physicians aware of CDSS use.
- Masking
- None (open label)
- Enrolment
- 448 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07647952
- Sponsor's protocol ID
- RC22_0577
- Other IDs
- 2026-A00510-51
- Acronym
- PRIMUS
- Status last verified
- Jun 2026
- First submitted
- 2 Jun 2026
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07647952
- Acronym / sponsor ID
- PRIMUS / RC22_0577
- Conditions
- Relapsing - Remitting Multiple Sclerosis
- Keywords
- multiple sclerosis, CDSS
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 448 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 30 Jun 2026 (estimated)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 15 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study uses a cluster-randomized design with hospital (where the patient receives MS care) as cluster. Each center will be randomly allocated in a 1:1 ratio to experimental group (using CDSS/ use of the CDSS during the consultation), control group (receive usual care).The study is conducted in an open-label manner, with both patients and treating physicians aware of CDSS use.
| Arm | Type | Receives |
|---|---|---|
| Consultation with clinical decision support system CDSS | Experimental | Device: Clinical decision support systemParticipants will undergo a consultation supported by a CDSS when initiation or modification of MS treatment is being considered. |
| Usual care (consultation without CDSS) | No intervention | –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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 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:
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical decision support systemThe 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 | Device | Consultation with clinical decision support system CDSS |
Primary outcome
Treatment choice
Time frame: 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.
13 secondary outcomes
Treatment decision concordance with expert recommendation
Time frame: Month 1
Patient Adherence: Concordance Between Prescribed and Actual Treatment
Time frame: Month 10, last visit
Treatment Decision Concordance with Dynamic Score Recommendation
Time frame: Month 1
Evolution of treatment decision
Time frame: Month 1
Cost-utility analysis of CDSS use
Time frame: Month 0 to Month 10
Patient-Reported Outcomes: Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) Score
Time frame: Month 0 and Month 10
Patient-Reported Outcomes: Health-Related Quality of life : 12-Item Short Form Health Survey (SF-12) Score
Time frame: Month 0 and Month 10
Clinician-Reported Usability of the Clinical Decision Support System (CDSS)
Time frame: Month 1
Patient experience with CDSS use Patient Experience with Clinical Decision Support System (CDSS) Use
Time frame: Month 1
Neurologist Experience with MRI Viewer Use During Consultation
Time frame: Month 1
Patient Experience with MRI Viewer Use During Consultation
Time frame: Month 1
Consultation duration
Time frame: Month 1
Device reliability
Time frame: Month 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Relapsing - Remitting Multiple Sclerosis
Active, not recruiting
Myrosinase Bioactivated Gglucoraphanin for the Treatment of Neurodegenerative Diseases (GRA-MYR-ND)
PARKINSON DISEASE (Disorder), Multiple Sclerosis (MS) - Relapsing-remitting
Recruiting
Wearable Focal Vibration Therapy on Upper Extremity Function of People With Multiple Sclerosis: A Pilot Study
Multiple Sclerosis (MS) - Relapsing-remitting, Upper Extremity Dysfunction
Not yet recruiting
Treatment of Memory Retrieval Impairments in MS With HDtDCS to the LIFG in a Placebo Controlled Trial
Multiple Sclerosis, Relapsing-remitting Multiple Sclerosis (RRMS)
Recruiting
Monthly Monitoring of Plasma NfL in Treated Relapsing-remitting Multiple Sclerosis to Detect Persistent Infraclinical Disease Activity
Multiple Sclerosis (MS) - Relapsing-remitting
Active, not recruitingPhase 4
Safety and Efficacy Study of Fingolimod in Taiwanese Adults (≥ 20years) With Relapsing Remitting Multiple Sclerosis
Multiple Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical decision support system in people with Relapsing - Remitting Multiple Sclerosis, run by Nantes University Hospital at 31 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David M LAPLAUD, Professor (02 40 16 52 85, david.laplaud@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment choice (time frame: once at Month 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.