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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Bonn

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Ex Vivo Assay

    Diagnostic test

    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.

Treatment groups

120 Participants
are divided into 5 treatment groups
Group A: Arthritis Group1 intervention
Group B: Vasculitis Group1 intervention
Group C: Connective Tissue Disease Group1 intervention
Group D: Autoinflammatory Disease Group1 intervention
Group E: Control Group1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
Baseline. Follow-up after 6 weeks, 3 months, 6 months, 12 months and in case of relapse or therapy change. Cross sectional: Baseline. Healthy Controls: Baseline.

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Bonn

Lead sponsor

University Hospital, Bonn

Sponsor institution