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
