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Clinical Assessment for Rheumatologic Disease - Research and Advancement in Safety and Efficacy
Sponsor: University of Bonn
Summary
The CARe RAiSE project represents a pioneering translational initiative aimed at advancing precision medicine in the treatment of autoimmune rheumatic diseases. The primary objective is the development and implementation of an innovative cell-based ex vivo assay that enables individualized prediction of therapeutic response to disease-modifying antirheumatic drugs (DMARDs). By identifying the most effective treatment option for each patient, this approach seeks to enhance therapeutic efficacy, reduce time to clinical response, and minimize healthcare costs. Despite the availability of numerous DMARDs, clinical decision-making remains largely empirical due to considerable interindividual variability in treatment response. This frequently results in a prolonged trial-and-error process, placing a significant burden on patients and the healthcare system. CARe RAiSE aims to overcome this limitation by providing a functional diagnostic tool that can predict a patient's immunological response to specific DMARDs prior to treatment initiation. The assay is based on peripheral blood mononuclear cells (PBMCs) obtained from individual patients, enabling a physiologically relevant assessment of immune responsiveness to targeted therapies. Combining high-content imaging with homogeneous well-based cytokine and inflammasome activity assays, the platform allows for a detailed single-cell analysis of inflammatory pathways. These data are used to generate predictive signatures of treatment response, thereby facilitating a mechanistically informed and personalized therapeutic strategy. Through this approach, CARe RAiSE introduces a scientifically grounded, efficient, and patient-specific method for DMARD selection, with the potential to substantially improve patient outcomes and reduce the socioeconomic impact of autoimmune rheumatic diseases.
Official title: CARe RAiSE Study - Clinical Assessment for Rheumatologic Disease - Research and Advancement in Safety and Efficacy
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
120
Start Date
2025-04-01
Completion Date
2028-12
Last Updated
2025-09-02
Healthy Volunteers
Yes
Conditions
Interventions
Ex Vivo Assay
Ex vivo assay with patient's PBMCs. Cytokine quantification (e.g. TNFα, IL-1β). HCI with single-cell analysis (\>100 features/cell). Data preprocessing and normalization to transfer for machine learning.
Locations (1)
University Hospital, Bonn
Bonn, North Rhine-Westphalia, Germany