Multiple SclerosisRECLAIMNCT06280755
Clinical Impact Through AI-assisted MS Care - A Retrospective Multi-center Observational Study.
An observational study of Multiple Sclerosis and NMO Spectrum Disorder, run by icometrix at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, NMO Spectrum Disorder, Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease
- How many people
- 7,000 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 Mar 2024to Apr 2027
- 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
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
Germany2 sites, 2 recruiting
- Recruiting
ERC Charité - Universitätsmedizin Berlin
Berlin, State of Berlin, 131256
Tanja Schmitz-Hübsch, PD Dr.
- Recruiting
Katholisches Klinikum Bochum - St. Joseph-Hospital
Bochum, Bochum, 44791
Carsten Lukas, Prof. Dr. med.
Czechia1 site, 1 recruiting
- Recruiting
General University Hospital Prague
Prague, Praha 2, 128 00
Dana Horakova, Doc. MUDr., PhD
About this study
Official title: Clinical Impact Through AI-assisted MS Care - A Retrospective Multi-center Observational Study
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.
Read the detailed description
There is a clear need for a data-driven and personalized treatment optimisation tool for people with Multiple Sclerosis (MS), in order to enable/support physicians to deploy appropriate therapeutic measures that will help to better slow down disease progression and eventually, progressive disability worsening. While early diagnosis and prognostic modelling is important to make data-driven recommendations for treatment optimisation, being able to disentangle and monitor the disability accumulation due to 'relapse associated worsening' or due to 'progression independent of relapse activity' will be key to optimizing treatment for the best possible long-term outcomes. The latter strongly depends on the availability of biomarkers that can detect and differentiate between these different forms of disease worsening.
With the RECLAIM study, we focus on gathering a centralized and harmonized dataset, enabling the secondary use of data to support prognosis for people with MS, as well as treatment optimisation in a real-world setting. As such, RECLAIM aims to develop MRI-based tools to better monitor disease progression in people with MS, as well as AI-based models that will support prognosis of individual disease course and treatment response, comprising: (i) a biomarker-based MS progression model, (ii) an MRI-focused generative model to predict brain characteristic evolution, and (iii) an interventional model for treatment optimisation. 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
- Multiple Sclerosis, NMO Spectrum Disorder, Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease, Radiologically Isolated Syndrome, Clinically Isolated Syndrome
- Keywords
- Multiple Sclerosis, Prognosis, Progression, AI models, disease worsening
- Medical subject headings
- Multiple Sclerosis, Neuromyelitis Optica, Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients from each institution who have contributed data to the database.
Measured: 4 years
The number of patients from each institution whose data was mapped to the common data model of the harmonised database.
Measured: 4 years
The number of patients from the control arms of clinical trials who have contributed data to the database.
Measured: 4 years
The data completeness of each variable in the harmonised database.
Measured: 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
Measured: 4 years
The validity of the data through an assessment of the amount of erroneous or impossible data entries for each variable.
Measured: 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).
Measured: 4 years
The temporal uniformity of the harmonised dataset over time as assessed by the average time between subsequent assessments of each variable.
Measured: 4 years
The presence of contextual information on standard data gathering and analysis processes of each institution
Measured: 4 years
The presence of a unique and pseudonymised patient ID for all data of each patient, allowing to link such data of each patient.
Measured: 4 years
The temporal uniformity of MRI data over time as assessed by the comparability of MRI scans and the average time between subsequent MRI assessments for each patient.
Measured: 4 years
The percentage of MRI data sets which are compliant with the MAGNIMS-CMSC-NAIMS acquisition guidelines.
Measured: 4 years
The percentage of MRI data sets for which the automated quality control process of icobrain ms did not indicate any quality issues upon analysis.
Measured: 4 years
The percentage of patients with a complete disease modifying treatment history available, from the date of diagnosis to the current day.
Measured: 4 years
The percentage of patients with a complete disease history available, from the date of diagnosis to the current day.
Measured: 4 years
The validity and temporal uniformity for disability assessment as clinically determined by EDSS, Functional systems score, T25FWT, 9HPT and SDMT.
Each of these scores will be assessed individually for the amount of erroneous or impossible data entries, as well as for the average time between subsequent assessments of each variable.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start1 Mar 2024
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 7,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- icometrix
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Charite University, Berlin, Germany, Ruhr University of Bochum, Technische Universität Dresden, University Hospital, Lille, Casa di Cura IGEA, General University Hospital, Prague, Hoffmann-La Roche, Bristol-Myers Squibb, Imcyse SA, AB Science, Nocturne UG, Aalto University
- Responsible party
- Sponsor
- Investigators
- Friedemann Paul, PhD, MD, Principal investigator, Max Delbrück Center - Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06280755
- Sponsor's protocol ID
- ICO-S-002
- Acronym
- RECLAIM
- Status last verified
- Dec 2025
- First submitted
- 23 Jan 2024
- Last updated
- 12 Dec 2025
- 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 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Impact Through AI-assisted MS Care - A Retrospective Multi-center Observational Study
- ClinicalTrials.gov ID
- NCT06280755
- Acronym / sponsor ID
- RECLAIM / ICO-S-002
- Conditions
- Multiple Sclerosis, NMO Spectrum Disorder, Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease, Radiologically Isolated Syndrome, Clinically Isolated Syndrome
- Keywords
- Multiple Sclerosis, Prognosis, Progression, AI models, disease worsening
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 7,000 participants (estimated)
- Lead sponsor
- icometrixIndustry (pharma, biotech, devices)
- Collaborators
- Charite University, Berlin, Germany, Ruhr University of Bochum, Technische Universität Dresden, University Hospital, Lille, Casa di Cura IGEA, General University Hospital, Prague, Hoffmann-La Roche, Bristol-Myers Squibb, Imcyse SA, AB Science, Nocturne UG, Aalto University
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 28 Feb 2024 (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 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.
Detailed description
There is a clear need for a data-driven and personalized treatment optimisation tool for people with Multiple Sclerosis (MS), in order to enable/support physicians to deploy appropriate therapeutic measures that will help to better slow down disease progression and eventually, progressive disability worsening. While early diagnosis and prognostic modelling is important to make data-driven recommendations for treatment optimisation, being able to disentangle and monitor the disability accumulation due to 'relapse associated worsening' or due to 'progression independent of relapse activity' will be key to optimizing treatment for the best possible long-term outcomes. The latter strongly depends on the availability of biomarkers that can detect and differentiate between these different forms of disease worsening.
With the RECLAIM study, we focus on gathering a centralized and harmonized dataset, enabling the secondary use of data to support prognosis for people with MS, as well as treatment optimisation in a real-world setting. As such, RECLAIM aims to develop MRI-based tools to better monitor disease progression in people with MS, as well as AI-based models that will support prognosis of individual disease course and treatment response, comprising: (i) a biomarker-based MS progression model, (ii) an MRI-focused generative model to predict brain characteristic evolution, and (iii) an interventional model for treatment optimisation. 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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The number of patients from each institution who have contributed data to the database.
Time frame: 4 years
The number of patients from each institution whose data was mapped to the common data model of the harmonised database.
Time frame: 4 years
The number of patients from the control arms of clinical trials who have contributed data to the database.
Time frame: 4 years
The data completeness of each variable in the harmonised database.
Time frame: 4 years
12 secondary outcomes
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
Time frame: 4 years
The validity of the data through an assessment of the amount of erroneous or impossible data entries for each variable.
Time frame: 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).
Time frame: 4 years
The temporal uniformity of the harmonised dataset over time as assessed by the average time between subsequent assessments of each variable.
Time frame: 4 years
The presence of contextual information on standard data gathering and analysis processes of each institution
Time frame: 4 years
The presence of a unique and pseudonymised patient ID for all data of each patient, allowing to link such data of each patient.
Time frame: 4 years
The temporal uniformity of MRI data over time as assessed by the comparability of MRI scans and the average time between subsequent MRI assessments for each patient.
Time frame: 4 years
The percentage of MRI data sets which are compliant with the MAGNIMS-CMSC-NAIMS acquisition guidelines.
Time frame: 4 years
The percentage of MRI data sets for which the automated quality control process of icobrain ms did not indicate any quality issues upon analysis.
Time frame: 4 years
The percentage of patients with a complete disease modifying treatment history available, from the date of diagnosis to the current day.
Time frame: 4 years
The percentage of patients with a complete disease history available, from the date of diagnosis to the current day.
Time frame: 4 years
The validity and temporal uniformity for disability assessment as clinically determined by EDSS, Functional systems score, T25FWT, 9HPT and SDMT.
Time frame: 4 years
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 12 Dec 2025.
- Website of the EU-funded CLAIMS project of which this study is a part.Link 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.
Friedemann Paul, PhD, MD principal investigator
Max Delbrück Center - Charite University, Berlin, Germany
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis and NMO Spectrum Disorder, run by icometrix at 3 sites in 2 countries.
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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, Czechia. 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 Diana M Sima, PhD (+32 16 369 000, diana.sima@icometrix.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of patients from each institution who have contributed data to the database. (time frame: 4 years). The study lists 4 primary outcomes in all. 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 12 Dec 2025.