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

NCT07150000 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2025-09-02

No results posted yet for this study

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.

Conditions

  • Rheumatic Diseases
  • Rheumatoid Arthritis (RA)
  • Giant Cell Arteritis (GCA)
  • Psoriatic Arthritis (PsA)
  • Axial Spondylarthritis (axSpA)
  • Polymyalgia Rheumatica (PMR)
  • ANCA Associated Vasculitis (AAV)
  • Connective Tissue Disease (CTD)
  • Systemic Sclerosis (SSc)
  • Systemic Lupus Erthematosus (SLE)
  • Idiopathic Inflammatory Myopathy (IIM)
  • Autoinflammatory Disease
  • Gout Arthritis

Interventions

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.

Sponsors & Collaborators

  • University of Bonn

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-04-01
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07150000 on ClinicalTrials.gov