NCT06460142 Assessing Biomarker in Giant Cell Arteritis and Polymyalgia Rheumatic
| NCT ID | NCT06460142 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Bonn |
| Condition | Giant Cell Arteritis |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-09-01 |
| Primary Completion | 2026-09-30 |
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 100 participants in total. It began in 2023-09-01 with a primary completion date of 2026-09-30.
⚠ 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 GCAIO study is an innovative, multimodal research initiative designed to enhance the understanding, diagnosis, and management of giant cell arteritis (GCA) and frequently associated polymyalgia rheumatica (PMR). This longitudinal study aims to dissect the complex immunological landscape and systemic manifestations of these conditions through a combination of diagnostic imaging and detailed immunological profiling. The study focuses on three primary objectives: (1) Identifying and analyzing cytokine profiles and immune cell phenotypes, employing techniques like flow cytometry, enzyme-linked immunosorbent assays (ELISA), and next-generation sequencing to predict disease activity and therapeutic responses. (2) Advancing diagnostic and monitoring capabilities through the application of novel and established imaging technologies, including MRI, optical coherence tomography angiography (OCTA), and ultrasound. These modalities aim to improve the detection of neuro-ophthalmological, cardiac, and aortic complications in GCA, potentially offering more precise monitoring and earlier diagnosis. (3) Enhancing the understanding of PMR within the context of GCA by exploring specific biomarkers and advanced imaging to refine diagnostic accuracy and treatment strategies, thus improving patient outcomes.
Eligibility 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.
Contact & Investigator
Valentin S. Schäfer, Univ. Prof.
PRINCIPAL INVESTIGATOR
Department of Rheumatology and Clinical Immunology, University Hospital Bonn
Frequently Asked Questions
Who can join the NCT06460142 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Giant Cell Arteritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06460142 currently recruiting?
Yes, NCT06460142 is actively recruiting participants. Contact the research team at Simon_Michael.Petzinna@ukbonn.de for enrollment information.
Where is the NCT06460142 trial being conducted?
This trial is being conducted at Bonn, Germany.
Who is sponsoring the NCT06460142 clinical trial?
NCT06460142 is sponsored by University of Bonn. The principal investigator is Valentin S. Schäfer, Univ. Prof. at Department of Rheumatology and Clinical Immunology, University Hospital Bonn. The trial plans to enroll 100 participants.