Understanding biomarkers in giant cell arteritis and polymyalgia rheumatica
Multimodal Assessment of Biomarkers for Diagnosing Giant Cell Arteritis and Polymyalgia Rheumatica: A Comprehensive Analysis of Clinical, Laboratory, and Imaging Profiles
University of Bonn · NCT06460142
This study is trying to find specific markers in the blood of people newly diagnosed with giant cell arteritis and polymyalgia rheumatica to help doctors understand their disease better and create personalized treatment plans.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Bonn (other) |
| Locations | 1 site (Bonn, North Rhine-Westphalia) |
| Trial ID | NCT06460142 on ClinicalTrials.gov |
What this trial studies
The GCAIO initiative is a longitudinal observational study aimed at enhancing the understanding, diagnosis, and management of giant cell arteritis (GCA) and polymyalgia rheumatica (PMR). It employs a multimodal approach that includes detailed immunological profiling and advanced imaging techniques to analyze cytokine profiles and immune cell phenotypes. The study focuses on patients at their first diagnosis and during disease flares, utilizing methods such as flow cytometry and next-generation sequencing to identify biomarkers that predict disease activity and therapeutic responses. Additionally, it aims to develop personalized treatment protocols based on individual immune profiles.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with a confirmed diagnosis of GCA or PMR who are either newly diagnosed or experiencing a disease flare.
Not a fit: Patients with severe renal insufficiency or other inflammatory rheumatic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic and treatment strategies for patients with giant cell arteritis and polymyalgia rheumatica.
How similar studies have performed: Other studies have shown promise in using similar multimodal approaches to understand and manage inflammatory disorders, but this specific initiative is innovative in its comprehensive integration of immunological and imaging techniques.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Informed Consent: Participants (\>18 years) must provide written informed consent to voluntarily participate in the study. * Confirmed Diagnosis: Diagnosis of GCA or PMR confirmed by the treating physician and fulfilling expanded ACR-EULAR classification criteria. Patients must have been either newly diagnosed within the last three days or have experienced a disease flare within the same timeframe. Exclusion Criteria: * Severe Renal Insufficiency: Chronic glomerular filtration rate (GFR) less than 30 mL/min. * Other Medical Conditions Requiring Glucocorticoids: Presence of medical conditions other than GCA or PMR that necessitate continuous or intermittent treatment with oral or parenteral glucocorticoids. * Other Inflammatory Rheumatic Diseases: Patients with other inflammatory rheumatic diseases.
Where this trial is running
Bonn, North Rhine-Westphalia
- University Hospital Bonn — Bonn, North Rhine-Westphalia, Germany (RECRUITING)
Study contacts
- Principal investigator: Valentin S. Schäfer, Univ. Prof. — Department of Rheumatology and Clinical Immunology, University Hospital Bonn
- Study coordinator: Simon M. Petzinna, Dr. med.
- Email: Simon_Michael.Petzinna@ukbonn.de
- Phone: 0049 151 582 337 07
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.
Conditions: Giant Cell Arteritis, Polymyalgia Rheumatica, Vasculitis, Inflammatory Disorders, Clinical Biomarkers, Predictive Biomarkers, Disease Activity Monitoring, Therapeutic Response