Actively Recruiting
Multimodal Assessment of Biomarkers for Diagnosing Giant Cell Arteritis and Polymyalgia Rheumatica: A Comprehensive Analysis of Clinical, Laboratory, and Imaging Profiles
Led by University of Bonn · Updated on 2025-04-10
100
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to improve understanding, diagnosis, and management of giant cell arteritis (GCA) and polymyalgia rheumatica (PMR), conditions involving inflammation of blood vessels and muscles. The study focuses on identifying immune system markers and using advanced imaging techniques to better detect disease activity, complications, and treatment responses. It also seeks to enhance diagnostic accuracy and develop personalized treatment strategies for these diseases. Participants diagnosed with GCA and/or PMR will undergo detailed immunological profiling, including cytokine analysis and immune cell phenotyping, using methods such as flow cytometry, ELISA, and RNA sequencing. Imaging assessments will include MRI, optical coherence tomography angiography, vascular and transorbital ultrasound, and contrast-enhanced ultrasound to detect vascular and neuro-ophthalmological involvement. Healthy volunteers matched by age and gender will serve as controls, undergoing similar assessments without treatment. Throughout the study, participants will be evaluated at multiple time points up to 18 months after diagnosis, including during disease flare-ups. Assessments include laboratory tests, imaging scans, and functional questionnaires to monitor disease progression, immune changes, and complications. Researchers will track outcomes such as neuro-ophthalmological, cardiac, and aortic involvement, as well as immune markers in blood. The study aims to provide new diagnostic standards and improve management and quality of life for affected patients.
CONDITIONS
Brief Title
Assessing Biomarker in Giant Cell Arteritis and Polymyalgia Rheumatic
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent to participate voluntarily
- Be 18 years of age or older
- Have a confirmed diagnosis of giant cell arteritis or polymyalgia rheumatica by a treating physician
- Diagnosis must meet expanded ACR-EULAR classification criteria
- Newly diagnosed within the last three days or experiencing a disease flare within the same timeframe
You will not qualify if you...
- Chronic kidney failure with glomerular filtration rate less than 30 mL/min
- Presence of other medical conditions requiring continuous or intermittent glucocorticoid treatment
- Diagnosed with other inflammatory rheumatic diseases
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 18 months
Participants undergo a comprehensive series of diagnostic tests including advanced imaging techniques and detailed immunological profiling to assess disease characteristics and activity.
Visits at baseline, 3 months, 6 months, 9 months, 12 months, 18 months, and during flare-ups
Duration - Up to 18 months
Participants are monitored over time to track disease progression, immune response changes, and potential neuro-ophthalmological, cardiac, and aortic involvement using repeated assessments.
Visits at baseline, 6 months, 12 months, 18 months, and during flare-ups
Trial Site Locations
Total: 1 location
1
University Hospital Bonn
Bonn, North Rhine-Westphalia, Germany, 53127
Actively Recruiting
Research Team
S
Simon M. Petzinna, Dr. med.
V
Valentin S. Schäfer, Univ. Prof.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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