Actively Recruiting
CARe RAiSE Study - Clinical Assessment for Rheumatologic Disease Research and Advancement in Safety and Efficacy
Led by University of Bonn · Updated on 2025-09-02
120
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are exploring a new way to personalize treatment for autoimmune and autoinflammatory rheumatic diseases. This study aims to develop and use a special cell-based test that helps predict how well patients will respond to disease-modifying antirheumatic drugs (DMARDs). By identifying the best treatment for each person, the study hopes to improve treatment success, shorten the time to see benefits, and lower healthcare costs. The approach focuses on analyzing immune cells from patients to better understand their response to different therapies. The study includes several groups: newly diagnosed patients without prior treatment, patients already on immunomodulatory therapy, and healthy individuals for comparison. Blood samples are collected at different times depending on the group. Researchers use advanced laboratory methods to test immune cell responses to DMARDs outside the body, measuring specific immune signals and gene activity. Archived tissue samples are also studied to link immune profiles with disease features. This design allows detailed analysis of immune function related to treatment. Participants will provide blood samples and undergo clinical assessments over time, including baseline and follow-up visits at 6 and 12 weeks, with additional optional visits if disease worsens or treatment changes. The study measures changes in immune cell types and activity using the ex vivo assay and other tests. Data are stored securely, and the study will compare predicted responses with actual clinical outcomes to validate the test's usefulness. Participants' involvement may last up to a year, with ongoing monitoring and data collection to support personalized therapy development.
CONDITIONS
Brief Title
Clinical Assessment for Rheumatologic Disease - Research and Advancement in Safety and Efficacy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants aged 65 18 years
- Signed written informed consent to participate voluntarily in the study
- Confirmed diagnosis of rheumatoid arthritis (RA)
- Confirmed diagnosis of psoriatic arthritis (PsA)
- Confirmed diagnosis of axial spondyloarthritis (axSpA)
- Confirmed diagnosis of giant cell arteritis (GCA)
- Confirmed diagnosis of connective tissue diseases including systemic lupus erythematosus (SLE), systemic sclerosis (SSc), mixed connective tissue disease (MCTD), idiopathic inflammatory myopathies (IIM)
- Confirmed diagnosis of ANCA-associated vasculitides including microscopic polyangiitis (MPA), granulomatosis with polyangiitis (GPA), eosinophilic granulomatosis with polyangiitis (EGPA)
- Confirmed diagnosis of 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 65 18 years for healthy control group
- Signed written informed consent for healthy control group
You will not qualify if you...
- Refusal to participate in the study or inability to provide informed consent
- Presence of a known or active rheumatologic disease for healthy control group
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months with additional visits in case of relapse or therapy change
Participants undergo peripheral blood sampling and detailed clinical assessments at baseline and follow-up visits to characterize immune responses and disease activity.
Baseline visit, follow-up visits at 6 weeks, 3 months, 6 months, and 12 months; additional visits if relapse or treatment adjustment occur
Duration - Single timepoint or as needed for relapse and treatment adjustment assessments
Participants under ongoing immunomodulatory therapy or healthy controls provide samples at a single timepoint for comparative analysis.
1 visit for cross-sectional cohort and healthy controls; additional visits if relapse or therapy change occur
Trial Site Locations
Total: 1 location
1
University Hospital, Bonn
Bonn, North Rhine-Westphalia, Germany, 53127
Actively Recruiting
Research Team
V
Valentin S. Schäfer, MD
S
Simon M. Petzinna, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
5
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