About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Aortic/ cardiac magnetic resonance imaging
- Vascular ultrasound
- Transorbital Ultrasound
- Contrast-Enhanced Ultrasound
- Optical coherence tomography angiography
- Fluorescein angiography
- Fundus autofluorescence
- Color Fundus Photography
- Cell-based ex-vivo assay with high-content analysis
- 3'mRNA sequencing
- Enzyme-linked immunosorbent assay
- Flow cytometry
- Laboratory assessment:
- Immunohistochemistry of Temporal Artery Biopsies
- Functional assessment questionnaires
Treatment groups
Sponsors and collaborators
University of Bonn
Lead sponsor
University Hospital, Bonn
Sponsor institution