Personalized lab test to predict the best treatment for rheumatic diseases
Official title: CARe RAiSE Study - Clinical Assessment for Rheumatologic Disease - Research and Advancement in Safety and Efficacy
Run by University of Bonn · NCT07150000 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | University of Bonn Academic / other |
| Locations | 1 site (Bonn, North Rhine-Westphalia) |
| Status | Recruiting |
| Started | April 1, 2025 |
| Main results expected | December 2028 |
| Study ends | December 2028 |
| Registry record updated | September 2, 2025 |
| Trial ID | NCT07150000 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Investigating the Role of Y Chromosome Mutations in Autoimmune Diseases
This study is trying to see how changes in the Y chromosome might affect the immune system and contribute to autoimmune diseases like Giant Cell Arteritis and Polymyalgia Rheumatica.
-
FT839 therapy for autoimmune diseases
This trial tests FT839, given alone or with rituximab, to see if it is safe and can help people with certain autoimmune diseases who have not responded to other treatments.
-
Butantan live tetravalent dengue vaccine for people with autoimmune rheumatic diseases
This study will test whether a single dose of the Butantan live tetravalent dengue vaccine is safe and produces immune responses in clinically stable people aged 12–59 with autoimmune rheumatic diseases compared with matched healthy volunteers.
-
HBI0101 CAR-T for refractory B‑cell autoimmune rheumatic diseases
This will test a single infusion of HBI0101 CAR‑T cells in adults with severe, treatment‑resistant B‑cell autoimmune diseases such as SLE, systemic sclerosis, idiopathic inflammatory myopathy, rheumatoid arthritis, or primary progressive MS.
-
Evaluating OL-108 for autoimmune diseases that have not responded to previous treatments
This study is testing a new treatment called OL-108 to see if it can help people with autoimmune diseases that haven't improved with other therapies.
-
Safety evaluation of CC312 in patients with autoimmune diseases
This study is testing a new treatment called CC312 to see if it's safe and tolerable for adults with autoimmune diseases like lupus and rheumatoid arthritis.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.