RECRUITINGOBSERVATIONAL

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

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

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Participants aged ≥ 18 years - Signed written willing to sign a consent form 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: 1. Systemic lupus erythematosus (SLE) 2. Systemic sclerosis (SSc) 3. Mixed connective tissue disease (MCTD) 4. Idiopathic inflammatory myopathies (IIM) - ANCA-associated vasculitides (AAV), including: 1. Microscopic polyangiitis (MPA) 2. Granulomatosis with polyangiitis (GPA) 3. Eosinophilic granulomatosis with polyangiitis (EGPA) - Autoinflammatory diseases, including 1. Familial Mediterranean fever (FMF) 2. Cryopyrin-associated periodic syndromes (CAPS) 3. TNF receptor-associated periodic syndrome (TRAPS) 4. Adult-onset Still's disease (AOSD) Who Should NOT Join This Trial: - Refusal to participate in the study or inability to provide willing to sign a consent form. Inclusion Criteria - Healthy Control Group: - Participants aged ≥ 18 years (capable of providing willing to sign a consent form). - Signed written willing to sign a consent form to participate voluntarily in the study. Exclusion Criteria - Healthy Control Group: \- Presence of a known or active rheumatologic disease. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * 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: 1. Systemic lupus erythematosus (SLE) 2. Systemic sclerosis (SSc) 3. Mixed connective tissue disease (MCTD) 4. Idiopathic inflammatory myopathies (IIM) * ANCA-associated vasculitides (AAV), including: 1. Microscopic polyangiitis (MPA) 2. Granulomatosis with polyangiitis (GPA) 3. Eosinophilic granulomatosis with polyangiitis (EGPA) * Autoinflammatory diseases, including 1. Familial Mediterranean fever (FMF) 2. Cryopyrin-associated periodic syndromes (CAPS) 3. TNF receptor-associated periodic syndrome (TRAPS) 4. Adult-onset Still's disease (AOSD) Exclusion Criteria: * Refusal to participate in the study or inability to provide informed consent. Inclusion Criteria - Healthy Control Group: * Participants aged ≥ 18 years (capable of providing informed consent). * Signed written informed consent to participate voluntarily in the study. Exclusion Criteria - Healthy Control Group: \- Presence of a known or active rheumatologic disease.

Treatments Being Tested

DIAGNOSTIC_TEST

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