Personalized lab test to predict the best treatment for rheumatic diseases
CARe RAiSE Study - Clinical Assessment for Rheumatologic Disease - Research and Advancement in Safety and Efficacy
This project tests a lab-based cell assay to see if it can predict which DMARD will work best for adults with autoimmune rheumatic diseases such as RA, PsA, axSpA, and GCA.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Bonn Academic / other |
| Locations | 1 site (Bonn, North Rhine-Westphalia) |
| Trial ID | NCT07150000 on ClinicalTrials.gov |
What this trial studies
The study uses an ex vivo cell-based assay and molecular profiling to characterize individual immune responses and build models that predict response to immunomodulatory therapies. It combines a prospective longitudinal cohort of newly diagnosed, treatment‑naïve patients with follow-up sampling, a cross‑sectional cohort of patients on ongoing therapy, and an age‑ and sex‑matched healthy control cohort. Participants provide blood and other samples at specified visits; optional sampling is allowed at relapse or after treatment changes. All recruitment and sampling occur through the Rheumatology Outpatient Clinic at the University Hospital Bonn.
Who should consider this trial
Good fit: Adults (≥18) with a confirmed autoimmune or autoinflammatory rheumatic diagnosis — for example RA, PsA, axSpA, GCA, connective tissue diseases, ANCA‑associated vasculitis, or autoinflammatory syndromes — whether newly diagnosed or on treatment, are eligible.
Not a fit: People under 18, individuals without one of the listed diagnoses, or those unable or unwilling to attend in‑person sampling visits are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the assay could help patients get the right DMARD faster, reduce months of trial‑and‑error, lower side effects, and cut healthcare costs.
How similar studies have performed: Related ex vivo functional assays have shown promise in early and preclinical work and a few small clinical studies, but applying this approach broadly across diverse rheumatic diseases is relatively novel and not yet widely validated.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bonn, North Rhine-Westphalia
- University Hospital, Bonn — Bonn, North Rhine-Westphalia, Germany (Recruiting)
Study contacts
- Study coordinator: Valentin S. Schäfer, MD
- Email: valentin.schaefer@ukbonn.de
- Phone: 0049 228 287 17016
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.