Giant Cell ArteritisGCAIONCT06460142
Assessing Biomarker in Giant Cell Arteritis and Polymyalgia Rheumatic
An observational study of Giant Cell Arteritis and Polymyalgia Rheumatica, run by University of Bonn at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Giant Cell Arteritis, Polymyalgia Rheumatica
- What is being tested?
- Aortic/ cardiac magnetic resonance imaging, Vascular ultrasound and Transorbital Ultrasound
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 1 Sep 2023to 30 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Bonn
Bonn, North Rhine-Westphalia, 53127
Simon M. Petzinna, Dr. med., 0049 151 582 337 07, Simon_Michael.Petzinna@ukbonn.de
Valentin S. Schäfer, Univ. Prof., 0049 228 287 17016, Valentin.Schaefer@ukbonn.de
About this study
Official title: Multimodal Assessment of Biomarkers for Diagnosing Giant Cell Arteritis and Polymyalgia Rheumatica: A Comprehensive Analysis of Clinical, Laboratory, and Imaging Profiles
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.
Read the detailed description
GCA is an immune-mediated vasculitis that affects medium and large-sized vessels, leading to vascular changes and occlusion due to severe vascular inflammation, neoangiogenesis, and remodeling. GCA has the potential to impact almost any organ. Despite advancements in understanding the pathophysiology and clinical manifestations of GCA, many aspects of the disease remain unexplored. The GCAIO study aims to fill these gaps using an integrative research approach to enhance the diagnosis, understanding, and management of GCA.
The GCAIO study cohort includes patients at their first diagnosis, throughout the disease, and during recurrent activity, facilitating a thorough longitudinal analysis of GCA. The research focuses on the complex immunological processes of the disease. Techniques such as flow cytometry (FACS), enzyme-linked immunosorbent assays (ELISA), and 3'-mRNA transcriptome analysis are employed to identify biomarkers that can assess GCA activity, track disease progression, and predict therapeutic responses, particularly for those unresponsive to interleukin (IL)-6 receptor (R) inhibitors. Additionally, the project is pioneering personalized treatment protocols tailored to individual immune profiles by developing a cell-based ex-vivo assay designed to forecast how patients will respond to different disease-modifying anti-rheumatic drugs (DMARDs).
Alongside the immunological research, the project emphasizes improving diagnostic and monitoring techniques through imaging technologies. Recent advancements have demonstrated that optimized diagnostics significantly enhance treatment outcomes for GCA patients. The planned prospective multimodal imaging aims to investigate potential neuro-ophthalmological, cardiac, and aortic manifestations during the course of GCA, enabling a detailed assessment of the involvement of various structures. Established imaging methods such as magnetic resonance imaging (MRI), optical coherence tomography angiography (OCTA), and vascular ultrasound are being extended into new areas to evaluate their diagnostic and prognostic merits. Furthermore, the investigators are exploring innovative diagnostic tools like transorbital ultrasound (TOS) and contrast-enhanced ultrasound (CEUS) for their potential as predictive biomarkers, facilitating earlier diagnosis and more precise disease monitoring. By correlating imaging findings with immunological data, our goal is to alter the way GCA is detected and monitored.
The inclusion of patients with PMR enhances our understanding of its pathophysiology, clinical manifestations, and its connection to often-associated GCA. The investigators are dedicated to developing new diagnostic criteria and exploring alternative therapeutic approaches for PMR maintenance therapy. By identifying alternative clinical, laboratory, or instrumental diagnostic methods to predict PMR, the investigators aim to set new diagnostic standards and deepen our understanding of its pathophysiology and immunological processes.
In summary, the goal of the GCAIO study is to make substantial contributions to the fields of GCA and PMR by developing innovative diagnostic and therapeutic strategies that improve treatment and quality of life for affected patients. The identification of specific biomarkers and the establishment of new diagnostic standards could lead to more precise diagnoses and optimized management of therapy, thereby enhancing patient care and reducing the risk of complications and therapy failures.
- Conditions
- Giant Cell Arteritis, Polymyalgia Rheumatica
- Being tested
- Aortic/ cardiac magnetic resonance imaging, Vascular ultrasound, Transorbital Ultrasound, Contrast-Enhanced Ultrasound, Optical coherence tomography angiography
- Keywords
- Giant Cell Arteritis, Polymyalgia Rheumatica, Vasculitis, Inflammatory Disorders, Clinical Biomarkers, Predictive Biomarkers, Disease Activity Monitoring, Therapeutic Response, Diagnostic Imaging Techniques, Aortic Imaging, Magnetic Resonance Imaging (MRI), Vascular Ultrasound, Optical Coherence Tomography Angiography (OCT-A), Transcriptome Analysis, Vascular-adhesion protein 1, Positron emission tomography-computed tomography (PET/CT), Siglec-9
- Medical subject headings
- Giant Cell Arteritis, Polymyalgia Rheumatica, Vasculitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aortic/ cardiac magnetic resonance imagingDiagnostic test
Also called Aortic/ cardiac MRI
MRI scans will be performed to detect systemic vascular involvement in GCA patients, aiming to provide detailed images of affected tissues.
Vascular ultrasoundDiagnostic test
Vascular ultrasound will be employed to examine the temporal and axillary arteries in GCA patients, searching for signs indicative of active inflammation.
Transorbital UltrasoundDiagnostic test
Also called TOS
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 UltrasoundDiagnostic test
Also called CEUS
Contrast-Enhanced Ultrasound (CEUS) is utilized to evaluate aortic involvement in GCA patients as an alternative, bed-side, realtime, radiation-free diagnostic tool.
Optical coherence tomography angiographyDiagnostic test
Also called OCTA
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 angiographyDiagnostic test
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.
Fundus autofluorescenceDiagnostic test
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 PhotographyDiagnostic test
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.
Cell-based ex-vivo assay with high-content analysisDiagnostic test
Also called GCAIO-essay
This assay predicts individual patient responses to different DMARDs by analyzing patient-derived PBMCs for specific immune responses to therapeutic agents.
3'mRNA sequencingDiagnostic test
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.
Enzyme-linked immunosorbent assayDiagnostic test
Also called ELISA
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.
Flow cytometryDiagnostic test
Also called FACS
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.
Laboratory assessment:Diagnostic test
Serum Chemistry (nt-proBNP, troponin T, CRP, ESR, blood count)
Immunohistochemistry of Temporal Artery BiopsiesDiagnostic test
Also called IHC TAB
Immunohistochemistry staining of TAB to assess local expression of endothelial adhesion molecules in acute inflammation.
Functional assessment questionnairesDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Aortic/ cardiac magnetic resonance imaging; Diagnostic Test: Vascular ultrasound; Diagnostic Test: Transorbital Ultrasound; Diagnostic Test: Contrast-Enhanced Ultrasound; Diagnostic Test: Optical coherence tomography angiography; Diagnostic Test: Fluorescein angiography; Diagnostic Test: Fundus autofluorescence; Diagnostic Test: Color Fundus Photography; Diagnostic Test: Cell-based ex-vivo assay with high-content analysis; Diagnostic Test: 3'mRNA sequencing; Diagnostic Test: Enzyme-linked immunosorbent assay; Diagnostic Test: Flow cytometry; Diagnostic Test: Laboratory assessment:; Diagnostic Test: Immunohistochemistry of Temporal Artery Biopsies; Diagnostic Test: Functional assessment questionnaires | |
| 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. Receives: Diagnostic Test: Aortic/ cardiac magnetic resonance imaging; Diagnostic Test: Vascular ultrasound; Diagnostic Test: Transorbital Ultrasound; Diagnostic Test: Contrast-Enhanced Ultrasound; Diagnostic Test: Optical coherence tomography angiography; Diagnostic Test: Fluorescein angiography; Diagnostic Test: Fundus autofluorescence; Diagnostic Test: Color Fundus Photography; Diagnostic Test: Cell-based ex-vivo assay with high-content analysis; Diagnostic Test: 3'mRNA sequencing; Diagnostic Test: Enzyme-linked immunosorbent assay; Diagnostic Test: Flow cytometry; Diagnostic Test: Laboratory assessment:; Diagnostic Test: Functional assessment questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: At baseline, 6 months, 12 months, 18 months, and during flare-ups (assessed up to 18 months after diagnosis).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start1 Sep 2023
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Giant Cell ArteritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bonn
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Valentin Schäfer, University Hospital, Bonn
- Investigators
- Valentin S. Schäfer, Univ. Prof., Principal investigator, Department of Rheumatology and Clinical Immunology, University Hospital Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06460142
- Sponsor's protocol ID
- 321/22
- Acronym
- GCAIO
- Status last verified
- Apr 2025
- First submitted
- 5 May 2024
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data are available upon reasonable request from the corresponding investigator.
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Assessment of Biomarkers for Diagnosing Giant Cell Arteritis and Polymyalgia Rheumatica: A Comprehensive Analysis of Clinical, Laboratory, and Imaging Profiles
- ClinicalTrials.gov ID
- NCT06460142
- Acronym / sponsor ID
- GCAIO / 321/22
- Conditions
- Giant Cell Arteritis, Polymyalgia Rheumatica
- Keywords
- Giant Cell Arteritis, Polymyalgia Rheumatica, Vasculitis, Inflammatory Disorders, Clinical Biomarkers, Predictive Biomarkers, Disease Activity Monitoring, Therapeutic Response
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of BonnUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 14 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
GCA is an immune-mediated vasculitis that affects medium and large-sized vessels, leading to vascular changes and occlusion due to severe vascular inflammation, neoangiogenesis, and remodeling. GCA has the potential to impact almost any organ. Despite advancements in understanding the pathophysiology and clinical manifestations of GCA, many aspects of the disease remain unexplored. The GCAIO study aims to fill these gaps using an integrative research approach to enhance the diagnosis, understanding, and management of GCA.
The GCAIO study cohort includes patients at their first diagnosis, throughout the disease, and during recurrent activity, facilitating a thorough longitudinal analysis of GCA. The research focuses on the complex immunological processes of the disease. Techniques such as flow cytometry (FACS), enzyme-linked immunosorbent assays (ELISA), and 3'-mRNA transcriptome analysis are employed to identify biomarkers that can assess GCA activity, track disease progression, and predict therapeutic responses, particularly for those unresponsive to interleukin (IL)-6 receptor (R) inhibitors. Additionally, the project is pioneering personalized treatment protocols tailored to individual immune profiles by developing a cell-based ex-vivo assay designed to forecast how patients will respond to different disease-modifying anti-rheumatic drugs (DMARDs).
Alongside the immunological research, the project emphasizes improving diagnostic and monitoring techniques through imaging technologies. Recent advancements have demonstrated that optimized diagnostics significantly enhance treatment outcomes for GCA patients. The planned prospective multimodal imaging aims to investigate potential neuro-ophthalmological, cardiac, and aortic manifestations during the course of GCA, enabling a detailed assessment of the involvement of various structures. Established imaging methods such as magnetic resonance imaging (MRI), optical coherence tomography angiography (OCTA), and vascular ultrasound are being extended into new areas to evaluate their diagnostic and prognostic merits. Furthermore, the investigators are exploring innovative diagnostic tools like transorbital ultrasound (TOS) and contrast-enhanced ultrasound (CEUS) for their potential as predictive biomarkers, facilitating earlier diagnosis and more precise disease monitoring. By correlating imaging findings with immunological data, our goal is to alter the way GCA is detected and monitored.
The inclusion of patients with PMR enhances our understanding of its pathophysiology, clinical manifestations, and its connection to often-associated GCA. The investigators are dedicated to developing new diagnostic criteria and exploring alternative therapeutic approaches for PMR maintenance therapy. By identifying alternative clinical, laboratory, or instrumental diagnostic methods to predict PMR, the investigators aim to set new diagnostic standards and deepen our understanding of its pathophysiology and immunological processes.
In summary, the goal of the GCAIO study is to make substantial contributions to the fields of GCA and PMR by developing innovative diagnostic and therapeutic strategies that improve treatment and quality of life for affected patients. The identification of specific biomarkers and the establishment of new diagnostic standards could lead to more precise diagnoses and optimized management of therapy, thereby enhancing patient care and reducing the risk of complications and therapy failures.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PMR/ GCA | – | Diagnostic Test: Aortic/ cardiac magnetic resonance imaging, Diagnostic Test: Vascular ultrasound, Diagnostic Test: Transorbital Ultrasound, Diagnostic Test: Contrast-Enhanced Ultrasound, Diagnostic Test: Optical coherence tomography angiography, Diagnostic Test: Fluorescein angiography, Diagnostic Test: Fundus autofluorescence, Diagnostic Test: Color Fundus Photography, Diagnostic Test: Cell-based ex-vivo assay with high-content analysis, Diagnostic Test: 3'mRNA sequencing, Diagnostic Test: Enzyme-linked immunosorbent assay, Diagnostic Test: Flow cytometry, Diagnostic Test: Laboratory assessment:, Diagnostic Test: Immunohistochemistry of Temporal Artery Biopsies, Diagnostic Test: Functional assessment questionnairesPatients 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 | – | Diagnostic Test: Aortic/ cardiac magnetic resonance imaging, Diagnostic Test: Vascular ultrasound, Diagnostic Test: Transorbital Ultrasound, Diagnostic Test: Contrast-Enhanced Ultrasound, Diagnostic Test: Optical coherence tomography angiography, Diagnostic Test: Fluorescein angiography, Diagnostic Test: Fundus autofluorescence, Diagnostic Test: Color Fundus Photography, Diagnostic Test: Cell-based ex-vivo assay with high-content analysis, Diagnostic Test: 3'mRNA sequencing, Diagnostic Test: Enzyme-linked immunosorbent assay, Diagnostic Test: Flow cytometry, Diagnostic Test: Laboratory assessment:, Diagnostic Test: Functional assessment questionnairesAge- 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aortic/ cardiac magnetic resonance imagingAlso: Aortic/ cardiac MRIMRI scans will be performed to detect systemic vascular involvement in GCA patients, aiming to provide detailed images of affected tissues. | Diagnostic test | Control Group, PMR/ GCA |
| Vascular ultrasoundVascular ultrasound will be employed to examine the temporal and axillary arteries in GCA patients, searching for signs indicative of active inflammation. | Diagnostic test | Control Group, PMR/ GCA |
| Transorbital UltrasoundAlso: TOSTransorbital 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. | Diagnostic test | Control Group, PMR/ GCA |
| Contrast-Enhanced UltrasoundAlso: CEUSContrast-Enhanced Ultrasound (CEUS) is utilized to evaluate aortic involvement in GCA patients as an alternative, bed-side, realtime, radiation-free diagnostic tool. | Diagnostic test | Control Group, PMR/ GCA |
| Optical coherence tomography angiographyAlso: OCTAOCTA 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. | Diagnostic test | Control Group, PMR/ GCA |
| Fluorescein angiographyFluorescein 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. | Diagnostic test | Control Group, PMR/ GCA |
| Fundus autofluorescenceThis 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. | Diagnostic test | Control Group, PMR/ GCA |
| Color Fundus PhotographyColor 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. | Diagnostic test | Control Group, PMR/ GCA |
| Cell-based ex-vivo assay with high-content analysisAlso: GCAIO-essayThis assay predicts individual patient responses to different DMARDs by analyzing patient-derived PBMCs for specific immune responses to therapeutic agents. | Diagnostic test | Control Group, PMR/ GCA |
| 3'mRNA sequencing3'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. | Diagnostic test | Control Group, PMR/ GCA |
| Enzyme-linked immunosorbent assayAlso: ELISAUsed 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. | Diagnostic test | Control Group, PMR/ GCA |
| Flow cytometryAlso: FACSEmployed 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. | Diagnostic test | Control Group, PMR/ GCA |
| Laboratory assessment:Serum Chemistry (nt-proBNP, troponin T, CRP, ESR, blood count) | Diagnostic test | Control Group, PMR/ GCA |
| Immunohistochemistry of Temporal Artery BiopsiesAlso: IHC TABImmunohistochemistry staining of TAB to assess local expression of endothelial adhesion molecules in acute inflammation. | Diagnostic test | PMR/ GCA |
| Functional assessment questionnairesThe 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. | Diagnostic test | Control Group, PMR/ GCA |
Primary outcome
Number of Participants with Detected Neuro-Ophthalmological Manifestations
Time frame: At baseline, 3 months, 6 months, 9 months, 12 months, 18 months, and during flare-ups (assessed up to 18 months after diagnosis).
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.
Number of Participants with Detected Cardiac and Aortic Involvement
Time frame: At baseline, 6 months, 12 months, 18 months, and during flare-ups (assessed up to 18 months after diagnosis).
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.
Changes in Immune Cell Phenotype
Time frame: At baseline, 6 months, 12 months, 18 months, and during flare-ups (assessed up to 18 months after diagnosis).
Identification and quantification of immune cell types including changes over time using FACS. Unit of Measure: Changes in levels (percentages).
Changes in Cytokine Profiles
Time frame: At baseline, 6 months, 12 months, 18 months, and during flare-ups (assessed up to 18 months after diagnosis).
Identification and quantification of cytokines including changes over time using 3'-mRNA transcriptome analysis. Unit of Measure: Changes in levels (pg/mL).
Levels of Siglec-9 in Blood
Time frame: At baseline, 6 months, 12 months, 18 months, and during flare-ups (assessed up to 18 months after diagnosis).
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).
Levels of sVAP-1 in Blood
Time frame: At baseline, 6 months, 12 months, 18 months, and during flare-ups (assessed up to 18 months after diagnosis).
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Vasculitis Research Group Bonn (VAREGBO)Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Data are available upon reasonable request from the corresponding investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Valentin S. Schäfer, Univ. Prof. principal investigator
Department of Rheumatology and Clinical Immunology, University Hospital Bonn
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Giant Cell Arteritis and Polymyalgia Rheumatica, run by University of Bonn at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Simon M. Petzinna, Dr. med. (0049 151 582 337 07, Simon_Michael.Petzinna@ukbonn.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Detected Neuro-Ophthalmological Manifestations (time frame: At baseline, 3 months, 6 months, 9 months, 12 months, 18 months, and during flare-ups (assessed up to 18 months after diagnosis).). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025.