Assessing Biomarker in Giant Cell Arteritis and Polymyalgia Rheumatic
GCAIO
Multimodal Assessment of Biomarkers for Diagnosing Giant Cell Arteritis and Polymyalgia Rheumatica: A Comprehensive Analysis of Clinical, Laboratory, and Imaging Profiles
1 other identifier
observational
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2023
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2023
CompletedFirst Submitted
Initial submission to the registry
May 5, 2024
CompletedFirst Posted
Study publicly available on registry
June 14, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2027
April 10, 2025
April 1, 2025
3.1 years
May 5, 2024
April 7, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Number of Participants with Detected Neuro-Ophthalmological Manifestations
Use of OCTA, TOS, and additional ocular imaging to assess and monitor ocular and cranial vascular abnormalities indicative of GCA. Unit of Measure: Number of participants.
At baseline, 3 months, 6 months, 9 months, 12 months, 18 months, and during flare-ups (assessed up to 18 months after diagnosis).
Number of Participants with Detected Cardiac and Aortic Involvement
Detection and monitoring of inflammatory changes and structural anomalies in the cardiac and aortic regions using MRI and CEUS. Unit of Measure: Number of participants.
At baseline, 6 months, 12 months, 18 months, and during flare-ups (assessed up to 18 months after diagnosis).
Changes in Immune Cell Phenotype
Identification and quantification of immune cell types including changes over time using FACS. Unit of Measure: Changes in levels (percentages).
At baseline, 6 months, 12 months, 18 months, and during flare-ups (assessed up to 18 months after diagnosis).
Changes in Cytokine Profiles
Identification and quantification of cytokines including changes over time using 3'-mRNA transcriptome analysis. Unit of Measure: Changes in levels (pg/mL).
At baseline, 6 months, 12 months, 18 months, and during flare-ups (assessed up to 18 months after diagnosis).
Levels of Siglec-9 in Blood
Measurement of Siglec-9 levels on immune cells including changes over time using FACS. Correlation with clinical assessments of disease activity and imaging findings. Unit of Measure: Changes in levels (percentages).
At baseline, 6 months, 12 months, 18 months, and during flare-ups (assessed up to 18 months after diagnosis).
Levels of sVAP-1 in Blood
Measurement of sVAP-1 levels in blood via ELISA including changes over time. Correlation with clinical assessments of disease activity and imaging findings. Unit of Measure: Changes in levels (ng/mL).
At baseline, 6 months, 12 months, 18 months, and during flare-ups (assessed up to 18 months after diagnosis).
Study Arms (2)
PMR/ GCA
Patients diagnosed with GCA and/or PMR will be enrolled in this cohort. They will undergo a series of interventions including immunological profiling (cytokine profiling and immune cell phenotyping using flow cytometry, ELISA, 3'mRNA sequencing, high content analysis via a cell-based ex-vivo assay), and diagnostic imaging (MRI, OCTA including further ophthalmological assessment, vascular and transorbital ultrasound. Samples will be collected from patients at various stages of the disease (t=0, t=6, t=12, t=18 months, during flare-ups). Furthermore, TAB will be stained with a VAP-1 antibody to assess the expression and localization of VAP-1 in the arterial tissue.
Control Group
Age- and gender-matched healthy subjects will serve as the control group to provide baseline data for comparative purposes. This group will not receive any treatment related to GCA or PMR but undergoes similar diagnostic procedures for baseline measurements, including imaging and immunological assessments.
Interventions
MRI scans will be performed to detect systemic vascular involvement in GCA patients, aiming to provide detailed images of affected tissues.
Vascular ultrasound will be employed to examine the temporal and axillary arteries in GCA patients, searching for signs indicative of active inflammation.
Transorbital ultrasound will be employed to assess the ophthalmic artery and its branches in GCA patients to detect intracranial inflammatory processes that could lead to severe neuro-ophthalmological complications.
Contrast-Enhanced Ultrasound (CEUS) is utilized to evaluate aortic involvement in GCA patients as an alternative, bed-side, realtime, radiation-free diagnostic tool.
OCTA will be used to assess vascular changes in the retina of GCA patients, providing detailed imaging that can help detect early signs of ocular involvement and identify risk factors of anterior ischemic optic neuropathy.
Fluorescein angiography will be performed to evaluate blood circulation and highlight any blockages in the blood vessels of the retina in patients with GCA to detect vascular abnormalities that may lead to severe vision complications.
This imaging technique will be used to observe the health of the retina and detect any changes in GCA patients that could suggest disease activity, particularly useful for assessing the integrity of the retinal pigment epithelium.
Color fundus photography will be used to document the appearance of the optic disc and retinal vasculature in GCA patients, aiding in the long-term monitoring of ocular changes and the effects of therapeutic interventions.
This assay predicts individual patient responses to different DMARDs by analyzing patient-derived PBMCs for specific immune responses to therapeutic agents.
3'mRNA sequencing analyzes gene expression profiles related to the immune response in PMR/GCA patients, aiding in understanding the genetic underpinnings of inflammation and vascular remodeling.
Used to measure cytokine levels in the serum and plasma of PMR/GCA patients, ELISA aids in profiling inflammatory markers that are indicative of disease activity and response to treatment.
Employed to analyze immune cell phenotypes in patients with PMR and/or GCA, this test helps identify various immune cell subsets and their activation states, which are critical for understanding disease mechanisms and guiding therapy.
Serum Chemistry (nt-proBNP, troponin T, CRP, ESR, blood count)
Immunohistochemistry staining of TAB to assess local expression of endothelial adhesion molecules in acute inflammation.
The following questionnaires will be applied: FACIT-Fatigue, SF-36, BAS, Birmingham Vasculitis Activity Score, Montreal Cognitive Assessment, Mini-Mental Status Examination. These questionnaires collectively provide a comprehensive evaluation of the functional status, quality of life, and mental health of patients with GCA and PMR.
Eligibility Criteria
The GCAIO study focuses on patients with newly diagnosed GCA and PMR or those experiencing a flare-up. The primary sites for patient recruitment include the ophthalmological and rheumatological departments of the University Hospital of Bonn, Germany. Additional participants can be referred by local rheumatologists and primary care physicians. Healthy controls are recruited through the ophthalmological and rheumatological department of the University Hospital Bonn.
You may qualify if:
- 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.
You may not qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Bonn
Bonn, North Rhine-Westphalia, 53127, Germany
Related Links
Biospecimen
PBMC, Pax-Tube, Serum, Temporal artery biopsy.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Valentin S. Schäfer, Univ. Prof.
Department of Rheumatology and Clinical Immunology, University Hospital Bonn
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Univ. Prof. Dr. med. Valentin Sebastian Schäfer
Study Record Dates
First Submitted
May 5, 2024
First Posted
June 14, 2024
Study Start
September 1, 2023
Primary Completion (Estimated)
September 30, 2026
Study Completion (Estimated)
September 30, 2027
Last Updated
April 10, 2025
Record last verified: 2025-04