Understanding biomarkers in giant cell arteritis and polymyalgia rheumatica

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The GCAIO initiative is a longitudinal observational study aimed at enhancing the understanding, diagnosis, and management of giant cell arteritis (GCA) and polymyalgia rheumatica (PMR). It employs a multimodal approach that includes detailed immunological profiling and advanced imaging techniques to analyze cytokine profiles and immune cell phenotypes. The study focuses on patients at their first diagnosis and during disease flares, utilizing methods such as flow cytometry and next-generation sequencing to identify biomarkers that predict disease activity and therapeutic responses. Additionally, it aims to develop personalized treatment protocols based on individual immune profiles.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Where it's running

• University Hospital Bonn
  Bonn, North Rhine-Westphalia, Germany Recruiting

Study contacts

• Principal investigator: Valentin S. Schäfer, Univ. Prof. — Department of Rheumatology and Clinical Immunology, University Hospital Bonn
• Study coordinator: Simon M. Petzinna, Dr. med.
• Email: Simon_Michael.Petzinna@ukbonn.de
• Phone: 0049 151 582 337 07

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.