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NCT Number: NCT07084480

Giant Cell Arteritis - Ways to Precision Medicine

Long-term follow-up of aortal adverse events, as well as glucocortioid-associated adverse events in patients with polymyalgia rheumatica (PMR) and giant cell arteritis (GCA).

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Key information

Conditions

Giant Cell Arteritis Arteritis Autoimmune Diseases Autoimmune Diseases of the Nervous System Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Immune System Diseases Nervous System Diseases Polymyalgia Rheumatic (PMR) Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Vascular Diseases Vasculitis Vasculitis, Central Nervous System

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsklinikum Würzburg

Würzburg, Germany

Location status: Recruiting

About this study

In this non-interventional cohort study the following aspects should be addressed:

  • Can regular imaging procedures help to better assess the risk of aortic aneurysms and dissections over a period of 5-10 years after initial diagnosis of GCA?
  • Which prognostic factors correlate with aortic events?
  • What conclusions can be drawn about glucocorticoid-associated side effects over the longer (5-year) course?
  • Can modern imaging in correlation with standardized clinical examination, serological markers and immunophenotypic testing define patient clusters within the clinically heterogeneous disease spectrum of GCA and PMR with the aim of individualizing therapy?
  • What is the value of orbital MRI together with an ophthalmologic examination including fudoscopy and optical coherence tomography (OCT) in the detection of ischemic manifestations of GCA?
  • Can a contrast agent-saving MRI technique (with 25 % less contrast agent) be used in GCA without impairing signal quality?
  • Can rare lymphocyte populations be found by immunophenotyping, which provide information on the probability of recurrence or allow therapy control?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age greater or similar to 18 years
  • Primary diagnosis of GCA or PMR

Exclusion criteria

  • Age under 18 years
  • lack of capacity to consent

Treatment and study plan

Primary outcomes

  1. Incidence of aortic adverse events

    Time frame: Within 5 years

    Aortic adverse events include new foramation or progress of aortic aneurysms, and aortic dissection

Secondary outcomes

  1. Incidence of glucocorticoid-related adverse events

    Time frame: within 5 years

    Assessment of the glucocorticoid toxicity index (GTI; excluding regular bone density measurements) to detect glucocorticoid-related adverse events.

    The GIT includes 1) a cumulative worsening score, which includes the cumulative glucocorticoid toxicity over time (minimum value of 0 and a maximum value of 439, a decrease is not possible) and 2) an aggregate improvement score, which allows for decreases and increases of toxicity (range from -346 to 439, with negative values indicating improvement and positive values indicating worsening of glucocorticoid toxicity)

  2. Detection of ischemic complications in the eyes

    Time frame: within 5 years

    Is orbital MRI together with optic coherence tomography suitable to detect ischemic manifestations of GCA in the eye?

  3. Performance of gadopiclenol in detecting vessel wall inflammation

    Time frame: within 5 years

    The contrast agent gadopiclenol should be evaluated for its use in MR angiography, i.e. if it depicts (peri) vessel wall inflammation equally to older contrast agents. In a sub-cohort of 20 % of the patients , MR angiographies will be performed with 25% reduced gadoplicenol.

Study contacts

Contact information is provided by the study sponsor or research team.

Hannah Labinsky

CONTACT

[email protected]

+4993120140100

Michael Gernert

CONTACT

[email protected]

+4993120140100

Sponsors and collaborators

Lead sponsor

Wuerzburg University Hospital

Other

Registry information

Official study title

Riesenzellarteriitis - Wege Zur "Precision Medicine"

Important dates

Study start
2025
Primary completion
2030
Study completion
2033
First posted
Jul 24, 2025
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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