Clinical Impact Through AI-assisted MS Care - A Retrospective Multi-center Observational Study.

NCT06280755 | Recruiting

• 1 other identifier: ICO-S-002
• Study Type: observational
• Target: 7,000
• Locations: 2 countries
• Sites: 3

Brief Summary

The RECLAIM study aims to gather a centralized and harmonized dataset, enabling the secondary use of data for building AI-based models that will support diagnosis and prognosis of individual Multiple Sclerosis patient's disease course and treatment response in a real-world setting. Additionally, the data will be used to generate further insights on Multiple Sclerosis progression as well as to develop the tools to monitor this progression.

Conditions

Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease; Multiple Sclerosis; NMO Spectrum Disorder; Radiologically Isolated Syndrome; Clinically Isolated Syndrome

Keywords

Multiple Sclerosis; Prognosis; Progression; AI models; disease worsening

Outcome Measures

Primary Outcomes (4)

• The number of patients from each institution who have contributed data to the database.

  4 years

• The number of patients from each institution whose data was mapped to the common data model of the harmonised database.

  4 years

• The number of patients from the control arms of clinical trials who have contributed data to the database.

  4 years

• The data completeness of each variable in the harmonised database.

  4 years

Secondary Outcomes (12)

• The representativeness of the harmonised dataset for the MS patient population as evaluated by age range, gender balance, the distribution of country of residence, the distribution of race/ethnicity and the distribution of educational level

  4 years

• The validity of the data through an assessment of the amount of erroneous or impossible data entries for each variable.

  4 years

• The temporal uniformity of each institution's data over time as assessed by the number of changes to variables over time (addition of new variables or variables no longer being captured, alterations to how variables are captured).

  4 years

• The temporal uniformity of the harmonised dataset over time as assessed by the average time between subsequent assessments of each variable.

  4 years

• The presence of contextual information on standard data gathering and analysis processes of each institution

  4 years

Study Arms (2)

Data from real-world clinical practice

Retrospective, real-world clinical data obtained via the 6 participating clinical centers in the study.

Data from the control arms of relevant clinical trials

Data from the control arms of relevant clinical trials obtained via the 4 participating pharmaceutical partners in the study.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study will include patients with a confirmed diagnosis of MS (Thompson et al., 2018), CIS, RIS, NMOSD (Wingerchuck et al., 2015), or MOGAD (Banwell et al., 2023). No other specifications are included. We envision a database that captures the diversity and heterogeneity of the population, in order to address factors influencing disease worsening that have not been investigated yet or have only been investigated to a very limited extent in previous studies.

You may qualify if:

• Patients must have a confirmed diagnosis of MS, NMOSD, MOGAD, CIS or RIS.
• Patient (or patient's legal representative) has previously signed and dated an informed consent form (ICF) for the secondary use of their data, or assent form. Alternatively, the secondary use of the patient's data is allowed following Institutional Review Board (IRB)/Ethical Committee (EC) approval in accordance with national and local subject privacy regulations.

You may not qualify if:

• Patients under 18 years of age will be excluded.
• Other unspecified reasons that, in the opinion of the Investigator or Joint Steering Committee, make the patient unsuitable for participation in the study.

Sponsors & Collaborators

• icometrix: lead
• Charite University, Berlin, Germany: collaborator
• Ruhr University of Bochum: collaborator
• Technische Universität Dresden: collaborator
• University Hospital, Lille: collaborator
• Casa di Cura IGEA: collaborator
• General University Hospital, Prague: collaborator
• Hoffmann-La Roche: collaborator
• Bristol-Myers Squibb: collaborator
• Imcyse SA: collaborator
• AB Science: collaborator
• Nocturne UG: collaborator
• Aalto University: collaborator

Study Sites (3)

General University Hospital Prague

Prague, Praha 2, 128 00, Czechia

RECRUITING

Katholisches Klinikum Bochum - St. Joseph-Hospital

Bochum, Bochum, 44791, Germany

RECRUITING

ERC Charité - Universitätsmedizin Berlin

Berlin, State of Berlin, 131256, Germany

RECRUITING

Related Links

• Website of the EU-funded CLAIMS project of which this study is a part.

MeSH Terms

Conditions

Multiple Sclerosis; Neuromyelitis Optica; Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease; Disease Progression

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Myelitis, Transverse; Optic Neuritis; Optic Nerve Diseases; Cranial Nerve Diseases; Eye Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Friedemann Paul, PhD, MD

  Max Delbrück Center - Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Diana M Sima, PhD

CONTACT

+32 16 369 000; diana.sima@icometrix.com

Vincenzo Anania

CONTACT

+32 16 369 000; vincenzo.anania@icometrix.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2024
• First Posted: February 28, 2024
• Study Start: March 1, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1); DE (2)