Multiple Sclerosis, Relapsing-RemittingClinnova-MSNCT07280871
Clinnova-MS: A Prospective Cohort Study of Patients With Multiple Sclerosis: A Trans-regional Digital Health Effort Unlocking the Potential of Artificial Intelligence and Data Science in Health Care
An observational study of Multiple Sclerosis, Relapsing-Remitting and Multiple Sclerosis, Chronic Progressive, run by Luxembourg Institute of Health at 1 site in Luxembourg.
Trial summary
The Clinnova-Multiple Sclerosis (MS) study is part of the Clinnova program (NCT06526364; NCT06235684 and NCT05733702), which seeks to advance precision medicine and the digitalization of healthcare through high-quality, interoperable health data. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Chronic Progressive, Clinically Isolated Syndrome
- What is being tested?
- Cohort
- How many people
- 100 participants
- Where
- 1 siteLuxembourg
- Study dates
- Dec 2026to Jun 2040
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with MS as follows: Diagnosed with MS according to the revised McDonald criteria 2017 or revised McDonald criteria 2024, all clinical forms inclusive (CIS, RRMS, SPMS, PPMS) AND early disease stages (< 3 years), OR presenting at hospital for evaluation of a change in therapy (flare) OR transitioning phase to progressive disease as evaluated based on EDSS.
Who may be able to join
- Signed informed consent form
- ≥ 18 years of age
- Willing and able to comply with the protocol for the duration of the study including data and samples collection as well as study visits and examinations.
- Diagnosed with MS according to the revised McDonald criteria 2017 or revised McDonald criteria 2024, all clinical forms inclusive (CIS, RRMS, SPMS, PPMS) AND early disease stages (< 3 years), OR presenting at hospital for evaluation of a change in therapy (flare) OR transitioning phase to progressive disease as evaluated based on EDSS.
Who cannot join
- Diagnosis uncertain (no fulfilment of inclusion criteria)
- Any condition that could potentially hamper the compliance with the study protocol, including study procedures and study visits such as mental disability that makes it difficult or impossible to answer questionnaires.
- Not fluent in any of the following languages: French, English or German.
- Known pregnancy before the inclusion into the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Luxembourg1 site
Centre Hospitalier de Luxembourg
Luxembourg, L-1210
Myriam CESCUTTI, Dr. MD, 352 44 11 - 6627, cescutti.myriam@chl.lu
About this study
The Clinnova-Multiple Sclerosis (MS) study is part of the Clinnova program (NCT06526364; NCT06235684 and NCT05733702), which seeks to advance precision medicine and the digitalization of healthcare through high-quality, interoperable health data.
This program focuses on people with multiple sclerosis (MS) and aims to identify objective surrogate markers derived from clinical, epidemiological, imaging, and omics data that can predict disease activity, such as progression or relapses.
Read more
By combining data science and artificial intelligence, the project seeks to improve patient stratification, support personalized therapeutic decisions, and provide insights into the mechanisms underlying treatment response and disease progression.
Although many therapies are available for MS, it remains challenging to determine the most appropriate strategy for each patient and to prevent long-term disability. Current treatments mainly target relapses and inflammation, with limited effects on chronic progression. Clinnova-MS will collect and analyze real-world and research data to better understand variability in disease activity and treatment outcomes, enabling more precise, evidence-based care within the standard of care. This study represents the first step toward the broader Clinnova objective: developing sustainable, personalized, and preventive healthcare for people living with MS.
Read the detailed description
Multiple sclerosis (MS) treatments have advanced substantially, yet selecting the most effective therapy and preventing long-term progression remain challenging because of the disease's heterogeneity and variable treatment responses. Current drugs mainly target relapses and inflammation, while only partially protecting against neurodegeneration. Identifying predictive and prognostic biomarkers and improving monitoring are key to more personalized, evidence-based MS care.
Clinnova-MS, part of the Clinnova program, is a prospective, observational cohort designed to explore objective markers of disease activity (progression or relapses) and treatment outcomes using clinical, imaging, molecular, digital, and patient-reported data. Artificial intelligence and data science will be applied to integrate information from sources such as MRI, deep molecular phenotyping, exposome data, Patient Reported Outcome Measures (PROMs)/Patient-Reported Experience Measures (PREMs), and connected devices.
Up to 800 participants with early MS, transitioning to progressive disease, or undergoing treatment change will be enrolled in France, Switzerland, Germany, and Luxembourg (about 100 at Centre Hospitalier du Luxembourg (CHL)). Participants will provide clinical data, biological samples (blood mandatory; other specimens optional), imaging (as per standard care), and digital health information. They will be followed for up to five years, with visits at baseline, 6 months (optional), 12 months, annual follow-up, and unscheduled visits if new symptoms or relapses occur.
- Conditions
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Chronic Progressive, Clinically Isolated Syndrome, Primary Progressive Multiple Sclerosis
- Being tested
- Cohort
- Keywords
- AI, Machine Learning, MS, phenotyping, personalised medicine
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Chronic Progressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CohortOther
Participants will provide data and samples for analysis. In the first year after inclusion, demographics, lifestyle, labs, and physical exams will be collected at baseline, 6, and 12 months. Patient-Reported Outcomes (PROs) and challenges will be gathered between visits via the dreaMS app. Biological samples (blood required; saliva, urine, stool, CSF, hair optional), tissue from endoscopic biopsy, and imaging (if done as standard care) will be taken at baseline, 6, and 12 months. One unscheduled visit may occur for flares or treatment changes. From month 12 to 4 years later, yearly medical data, PROs every 6 months, and continuous smartwatch data will be collected.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm Study | Patients with MS Receives: Other: Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of Clinical, Imaging, and Omics Signatures for MS Subtype Stratification
Identify clinical, epidemiological, imaging and omics characteristics associated with changes of status for different subtypes of MS patients allowing the stratification of these patients according to similar patterns and disease courses.The primary endpoint will be the change of status of the patients' disease between the baseline and at Year 1. The status of the disease will be determined by using the No Evidence of Disease Activity (NEDA MS- 3).
Measured: 1 year
Secondary outcomes (1)
Building Resources and Digital Tools to Advance Research and Healthcare in Multiple Sclerosis
- To identify clinical, imaging, epidemiological, omics and digital characteristics associated with MS disease activity triggering a treatment change.
- To establish a sample and data bank to enable biomedical research.
- To develop digital applications for improved interactions between patients and medical doctors, hence support improving healthcare.
The secondary endpoints will be:
- "Treatment change" (yes/no), a binary variable, defining if the current treatment has been changed at a time point/visit. The goal is to identify surrogate biomarkers for the clinician's decision to apply a treatment change. Treatment change is defined as either:
- Change of drug dosage
- Change of medication within the same treatment class
- Change of treatment class
- Change in participant reported outcomes and their evolution since baseline (improvement/worsening)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study startDec 2026 (estimated)
- Primary completionJun 2032 (estimated)
- Study completionJun 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Luxembourg Institute of Health
- Sponsor type
- Other government
- Collaborators
- Centre Hospitalier du Luxembourg, Luxembourg National Research Fund
- Responsible party
- Sponsor
- Investigators
- Krüger Rejko, Prof. Dr. MD, Principal investigator, LIH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07280871
- Sponsor's protocol ID
- LUX-CLIN-03
- Acronym
- Clinnova-MS
- Status last verified
- Dec 2025
- First submitted
- 1 Dec 2025
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinnova-MS: A Prospective Cohort Study of Patients With Multiple Sclerosis: A Trans-regional Digital Health Effort Unlocking the Potential of Artificial Intelligence and Data Science in Health Care
- ClinicalTrials.gov ID
- NCT07280871
- Acronym / sponsor ID
- Clinnova-MS / LUX-CLIN-03
- Conditions
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Chronic Progressive, Clinically Isolated Syndrome, Primary Progressive Multiple Sclerosis
- Keywords
- AI, Machine Learning, MS, phenotyping, personalised medicine
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Luxembourg Institute of HealthOther government
- Collaborators
- Centre Hospitalier du Luxembourg, Luxembourg National Research Fund
- Study start
- Dec 2026 (estimated)
- Primary completion
- Jun 2032 (estimated)
- Study completion
- Jun 2040 (estimated)
- First posted
- 12 Dec 2025 (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.
The Clinnova-Multiple Sclerosis (MS) study is part of the Clinnova program (NCT06526364; NCT06235684 and NCT05733702), which seeks to advance precision medicine and the digitalization of healthcare through high-quality, interoperable health data.
This program focuses on people with multiple sclerosis (MS) and aims to identify objective surrogate markers derived from clinical, epidemiological, imaging, and omics data that can predict disease activity, such as progression or relapses.
By combining data science and artificial intelligence, the project seeks to improve patient stratification, support personalized therapeutic decisions, and provide insights into the mechanisms underlying treatment response and disease progression.
Although many therapies are available for MS, it remains challenging to determine the most appropriate strategy for each patient and to prevent long-term disability. Current treatments mainly target relapses and inflammation, with limited effects on chronic progression. Clinnova-MS will collect and analyze real-world and research data to better understand variability in disease activity and treatment outcomes, enabling more precise, evidence-based care within the standard of care. This study represents the first step toward the broader Clinnova objective: developing sustainable, personalized, and preventive healthcare for people living with MS.
Detailed description
Multiple sclerosis (MS) treatments have advanced substantially, yet selecting the most effective therapy and preventing long-term progression remain challenging because of the disease's heterogeneity and variable treatment responses. Current drugs mainly target relapses and inflammation, while only partially protecting against neurodegeneration. Identifying predictive and prognostic biomarkers and improving monitoring are key to more personalized, evidence-based MS care.
Clinnova-MS, part of the Clinnova program, is a prospective, observational cohort designed to explore objective markers of disease activity (progression or relapses) and treatment outcomes using clinical, imaging, molecular, digital, and patient-reported data. Artificial intelligence and data science will be applied to integrate information from sources such as MRI, deep molecular phenotyping, exposome data, Patient Reported Outcome Measures (PROMs)/Patient-Reported Experience Measures (PREMs), and connected devices.
Up to 800 participants with early MS, transitioning to progressive disease, or undergoing treatment change will be enrolled in France, Switzerland, Germany, and Luxembourg (about 100 at Centre Hospitalier du Luxembourg (CHL)). Participants will provide clinical data, biological samples (blood mandatory; other specimens optional), imaging (as per standard care), and digital health information. They will be followed for up to five years, with visits at baseline, 6 months (optional), 12 months, annual follow-up, and unscheduled visits if new symptoms or relapses occur.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm Study | – | Other: CohortPatients with MS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with MS as follows: Diagnosed with MS according to the revised McDonald criteria 2017 or revised McDonald criteria 2024, all clinical forms inclusive (CIS, RRMS, SPMS, PPMS) AND early disease stages (< 3 years), OR presenting at hospital for evaluation of a change in therapy (flare) OR transitioning phase to progressive disease as evaluated based on EDSS.
Key inclusion criteria (4 listed)
- Signed informed consent form
- ≥ 18 years of age
- Willing and able to comply with the protocol for the duration of the study including data and samples collection as well as study visits and examinations.
- Diagnosed with MS according to the revised McDonald criteria 2017 or revised McDonald criteria 2024, all clinical forms inclusive (CIS, RRMS, SPMS, PPMS) AND early disease stages (< 3 years), OR presenting at hospital for evaluation of a change in therapy (flare) OR transitioning phase to progressive disease as evaluated based on EDSS.
Key exclusion criteria (4 listed)
- Diagnosis uncertain (no fulfilment of inclusion criteria)
- Any condition that could potentially hamper the compliance with the study protocol, including study procedures and study visits such as mental disability that makes it difficult or impossible to answer questionnaires.
- Not fluent in any of the following languages: French, English or German.
- Known pregnancy before the inclusion into the study
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 |
|---|---|---|
| CohortParticipants will provide data and samples for analysis. In the first year after inclusion, demographics, lifestyle, labs, and physical exams will be collected at baseline, 6, and 12 months. Patient-Reported Outcomes (PROs) and challenges will be gathered between visits via the dreaMS app. Biological samples (blood required; saliva, urine, stool, CSF, hair optional), tissue from endoscopic biopsy, and imaging (if done as standard care) will be taken at baseline, 6, and 12 months. One unscheduled visit may occur for flares or treatment changes. From month 12 to 4 years later, yearly medical data, PROs every 6 months, and continuous smartwatch data will be collected. | Other | Single Arm Study |
Primary outcome
Identification of Clinical, Imaging, and Omics Signatures for MS Subtype Stratification
Time frame: 1 year
Identify clinical, epidemiological, imaging and omics characteristics associated with changes of status for different subtypes of MS patients allowing the stratification of these patients according to similar patterns and disease courses.The primary endpoint will be the change of status of the patients' disease between the baseline and at Year 1. The status of the disease will be determined by using the No Evidence of Disease Activity (NEDA MS- 3).
1 secondary outcome
Building Resources and Digital Tools to Advance Research and Healthcare in Multiple Sclerosis
Time frame: 1 year
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 22 Sep 2026.
- Webpage to gather information on the Clinnova programme; Clinnova: a precision health initiative in the heart of EuropeLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Krüger Rejko, Prof. Dr. MD principal investigator
LIH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, Relapsing-Remitting and Multiple Sclerosis, Chronic Progressive, run by Luxembourg Institute of Health at 1 site in Luxembourg.
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 4 inclusion and 4 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 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Luxembourg. 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 Jasmin Schulz, PhD (352 26970-265, Jasmin.Schulz@lih.lu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of Clinical, Imaging, and Omics Signatures for MS Subtype Stratification (time frame: 1 year). 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 22 Sep 2026.