Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
NCT06460142

Assessing Biomarker in Giant Cell Arteritis and Polymyalgia Rheumatic

Led by University of Bonn · Updated on 2025-04-10

100

Participants Needed

1

Research Sites

212 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Assessing Biomarker in Giant Cell Arteritis and Polymyalgia Rheumatic

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants must be 18 years or older and provide written informed consent.
  • Diagnosis of giant cell arteritis or polymyalgia rheumatica confirmed by a physician using expanded ACR-EULAR classification criteria.
  • Participants must be newly diagnosed or have had a disease flare within the last three days.
Not Eligible

You will not qualify if you...

  • Severe kidney failure with a glomerular filtration rate less than 30 mL/min.
  • Presence of medical conditions other than GCA or PMR requiring treatment with glucocorticoids.
  • Having other inflammatory rheumatic diseases.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University Hospital Bonn

Bonn, North Rhine-Westphalia, Germany, 53127

Actively Recruiting

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Research Team

S

Simon M. Petzinna, Dr. med.

CONTACT

V

Valentin S. Schäfer, Univ. Prof.

CONTACT

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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