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The RECLAIM study is part of the EU-funded research project “Clinical impact through AI-assisted MS Care” (CLAIMS) and constitutes one of the two clinical studies within the CLAIMS project. The study aims to gather previously collected data from people with Multiple Sclerosis (MS) to create a large database that incorporates both real-world clinical information of people with MS, as well as data from clinical trials in which people with MS participated. This combined dataset will serve as the foundation for developing Artificial Intelligence (AI)-driven models to support the prognosis of an individual’s disease progression and treatment response. Furthermore, the data will be instrumental in advancing our understanding of how MS progresses, and it will allow us to develop new and better tools to monitor this disease progression.


Currently, there are 6 clinical centers participating in the RECLAIM study, with several new clinical centers having shown interest in joining the study. The current 6 centers are : Charité Universitätsmedizin Berlin/Technische Universität Dresden/Ruhr Universität Bochum/CHU Lille/Casa di Cura Igea/General University Hospital in Prague.

If you would like to contribute to the RECLAIM study, the best option would be to make your treating physician aware of this study. If your physician is interested, they can reach out to us via info@claims.ms to see whether their institution or hospital can join the study.

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There is a clear need for a data-driven and personalized treatment optimization tool for people with Multiple Sclerosis (MS), in order to support physicians to choose 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 optimization, 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 database on people with MS, enabling the secondary use of this data to support the development of tools and models for an accurate prognosis for people with MS, as well as treatment optimisation in a real-world setting. As such, the RECLAIM study 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 MS progression as well as to develop the tools to monitor this progression.

The study will include patients from routine clinical care (via the academic partners in the project) with a confirmed diagnosis of MS (Thompson et al., 2018), Clinically Isolated Syndrome (CIS), Radiologically Isolated Syndrome (RIS), Neuromyelitis Optica Spectrum Disorder (NMOSD) (Wingerchuck et al., 2015), or Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (MOGAD) (Banwell et al., 2023). The database will be expanded with additional data on pwMS, coming from Randomised Clinical Trials (RCT) conducted by the pharmaceutical companies affiliated with the CLAIMS consortium. 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.

The data collected may include disease history and status, clinical tests, treatment details, comorbidities, fluid biomarkers, demographics, patient-reported outcomes, Magnetic Resonsance Imaging (MRI), Optical Coherence Tomography (OCT), and Evoked Potentials (EP). Subclinical data (MRI, OCT, EP) will be analysed to extract quantitative information and thereafter all data will be mapped to a common data model based on the MS Data Alliance (MSDA) Core Dataset (Parciak et al., 2023).

Additional information about the RECLAIM study can be found via clinicaltrials.gov, or you can reach out to us via info@claims.ms.

References

– Banwell et al., 2023 – doi:10.1016/S1474-4422(22)00431-8
– Parciak et al., 2024 – doi:10.1177/13524585231216004)
– Thompson et al., 2018 – doi:10.1016/S1474-4422(17)30470-2
– Wingerchuck et al., 2015 – doi:10.1212/WNL.0000000000001729

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