About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Participants aged ≥ 18 years
Signed written informed consent to participate voluntarily in the study.
Rheumatoid arthritis (RA)
Psoriatic arthritis (PsA)
Disqualifiers
Refusal to participate in the study or inability to provide informed consent.
Participants aged ≥ 18 years (capable of providing informed consent).
Signed written informed consent to participate voluntarily in the study.
Trial population
Participants will be recruited from the outpatient rheumatology clinic at the University Hospital Bonn. The study population includes adult patients (≥ 18 years) with a confirmed diagnosis of an autoimmune or autoinflammatory rheumatic disease, including: rheumatoid arthritis (RA), psoriatic arthritis (PsA), axial spondyloarthritis (axSpA), giant cell arteritis (GCA), connective tissue diseases \[systemic lupus erythematosus (SLE), systemic sclerosis (SSc), mixed connective tissue disease (MCTD), idiopathic inflammatory myopathies (IIM)\], ANCA-associated vasculitides \[microscopic polyangiitis (MPA), granulomatosis with polyangiitis (GPA), eosinophilic granulomatosis with polyangiitis (EGPA)\], and autoinflammatory disorders. In addition, age- and sex-matched healthy controls without known rheumatologic conditions will be included for comparative analysis. All participants must be able and willing to provide informed cons
Trial design
Cohort
Prospective
Treatments tested in this trial
Ex Vivo Assay
Diagnostic testEx 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.
Treatment groups
Trial outcomes
Primary outcomes
Changes in Immune Cell Phenotype in the Ex-Vivo Assay
Identification and quantification of immune cell subtypes, using the Ex-Vivo Essay. Unit of Measure: Changes in levels (percentages).
Sponsors and contacts
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University of Bonn
Lead sponsor
University Hospital, Bonn
Sponsor institution