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
Trial ID: NCT07280871
Status: NOT_YET_RECRUITING
Study type: OBSERVATIONAL
Start date: 2026-06
Completion date: 2040-06
Sponsor: Luxembourg Institute of Health
Collaborators: Centre Hospitalier du Luxembourg; Luxembourg National Research Fund
Conditions: Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis, Chronic Progressive; Clinically Isolated Syndrome; Primary Progressive Multiple Sclerosis
Interventions: Cohort
Locations: Centre Hospitalier de Luxembourg
Countries: Luxembourg
Enrollment: 100
Age range: 18 Years - None
Sex: ALL

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.

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.

Eligibility criteria:
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

Outcomes:
Identification of Clinical, Imaging, and Omics Signatures for MS Subtype Stratification