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NCT Number: NCT07280871

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

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.

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Key information

Conditions

Multiple Sclerosis, Relapsing-Remitting Autoimmune Diseases Autoimmune Diseases of the Nervous System Chronic Disease Clinically Isolated Syndrome Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Disease Attributes Immune System Diseases Multiple Sclerosis Multiple Sclerosis, Chronic Progressive Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Primary Progressive Multiple Sclerosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Cohort

Other

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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:

    • "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)

Other outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jasmin Schulz, PhD

CONTACT

[email protected]

352 26970-265

Sponsors and collaborators

Lead sponsor

Luxembourg Institute of Health

Other Gov

Collaborators

  • Centre Hospitalier du Luxembourg
  • Luxembourg National Research Fund

Registry information

Acronym: Clinnova-MS

Important dates

Study start
2026
Primary completion
2032
Study completion
2040
First posted
Dec 12, 2025
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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