NCT07150000 Clinical Assessment for Rheumatologic Disease - Research and Advancement in Safety and Efficacy
| NCT ID | NCT07150000 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Bonn |
| Condition | Rheumatic Diseases |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-04-01 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2025-04-01 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07150000 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Rheumatic Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07150000 currently recruiting?
Yes, NCT07150000 is actively recruiting participants. Contact the research team at valentin.schaefer@ukbonn.de for enrollment information.
Where is the NCT07150000 trial being conducted?
This trial is being conducted at Bonn, Germany.
Who is sponsoring the NCT07150000 clinical trial?
NCT07150000 is sponsored by University of Bonn. The trial plans to enroll 120 participants.