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 (Clinnova-MS)

December 31, 2025 updated by: Luxembourg Institute of Health

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Luxembourg
      • Luxembourg, Luxembourg, L-1210
        • Centre Hospitalier de Luxembourg
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  1. Signed informed consent form
  2. ≥ 18 years of age
  3. 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.
  4. 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.

Exclusion Criteria:

  1. Diagnosis uncertain (no fulfilment of inclusion criteria)
  2. 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.
  3. Not fluent in any of the following languages: French, English or German.
  4. Known pregnancy before the inclusion into the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Single Arm Study
Patients with MS
Other: Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Building Resources and Digital Tools to Advance Research and Healthcare in Multiple Sclerosis
Time Frame: 1 year
  • 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:

  1. "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
  2. Change in participant reported outcomes and their evolution since baseline (improvement/worsening)
1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Unraveling Molecular, Cellular, and Clinical Determinants of MS Activity and Progression"
Time Frame: 5 years
  • Explore the therapies, biomarkers, health outcomes and their interaction with patient characteristics.
  • Derive and combine a set of biomarkers to better characterize the disease clinical phenotype and progression, the functional impairment of MS patients in different disease stages, and either associated with early MS or with transitioning phase to progressive MS, as an aid to assist clinicians in applying treatment change.
  • Identify on a granular level, novel metabolic and epigenetic (if available) drivers of the immune response in MS patients, and by doing so to understand the multiple molecular and cellular pathways underlying central nervous system pathology at the interface between inflammation and neural function.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Luxembourg Institute of Health

Collaborators

Centre Hospitalier du Luxembourg
Luxembourg National Research Fund

Investigators

  • Principal Investigator: Krüger Rejko, Prof. Dr. MD, LIH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2032

Study Completion (Estimated)

June 1, 2040

Study Registration Dates

First Submitted

December 1, 2025

First Submitted That Met QC Criteria

December 1, 2025

First Posted (Estimated)

December 12, 2025

Study Record Updates

Last Update Posted (Actual)

January 6, 2026

Last Update Submitted That Met QC Criteria

December 31, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LUX-CLIN-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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