Testing blood cells to predict which arthritis drug may work for each patient

Trial details

Who runs it

University of Bonn

Trial code

NCT07150000

Record updated

2 September 2025

Original description

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.Read full original descriptionShow less

CARe RAiSE Study - Clinical Assessment for Rheumatologic Disease - Research and Advancement in Safety and Efficacy

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.

Inclusion: Participants aged ≥ 18 years; Signed written informed consent to participate voluntarily in the study; Confirmed diagnosis (by the treating physician) of one of the following autoimmune or autoinflammatory rheumatic diseases:; Rheumatoid arthritis (RA); Psoriatic arthritis (PsA); Axial spondyloarthritis (axSpA); Giant cell arteritis (GCA); Connective tissue diseases, including:; Systemic lupus erythematosus (SLE); Systemic sclerosis (SSc); Mixed connective tissue disease (MCTD); Idiopathic inflammatory myopathies (IIM); ANCA-associated vasculitides (AAV), including:; Microscopic polyangiitis (MPA); Granulomatosis with polyangiitis (GPA); Eosinophilic granulomatosis with polyangiitis (EGPA); Autoinflammatory diseases, including; Familial Mediterranean fever (FMF); Cryopyrin-associated periodic syndromes (CAPS); TNF receptor-associated periodic syndrome (TRAPS); Adult-onset Still's disease (AOSD); Participants aged ≥ 18 years (capable of providing informed consent); Signed written informed consent to participate voluntarily in the study.

Exclusion: Presence of a known or active rheumatologic disease; Refusal to participate in the study or inability to provide informed consent.

ClinicalTrials.gov NCT07150000