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RecruitingNCT07084480Updated Dec 22, 2025

Giant Cell Arteritis - Ways to Precision Medicine

An observational study in Giant Cell Arteritis and Polymyalgia Rheumatic (PMR), sponsored by Wuerzburg University Hospital. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-22.

Sponsored by Wuerzburg University Hospital · Observational

From the registry’s dates

  • Started Nov 2025; still recruiting 11 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
400
Ages
18 Years and older
Sex
All
01

Study summary

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).

Read the detailed description

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?
02

Conditions studied

  • Giant Cell Arteritis
  • Polymyalgia Rheumatic (PMR)

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Keywords

  • non-interventional cohort study
  • aortic dilatation
  • innate lymhoid cells
  • optic coherence tomography
  • MRI
03

In context

Giant Cell Arteritis

147 studies on the registry are indexed under Giant Cell Arteritis; 49 are open to participants now.

This study's planned enrollment of 400 is above the median of 128 across 78 observational studies indexed under Giant Cell Arteritis.

Browse Giant Cell Arteritis studies →

Lead sponsor

Wuerzburg University Hospital is the lead sponsor of 98 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

GCA and PMR patients will be recruited in the department of rheumatology of the university hospital of Würzburg

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Age under 18 years
  • lack of capacity to consent
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
400 participants (estimated)
Patient registry
No

Groups and cohorts

  • Known patients

    Patients, who are already known and had regular visits in the outpatient rheumatology department of the Würzburg university hospital. These patients already receive immunosuppressive therapy.

  • New patients

    Patients who have not yet been treated by the outpatient rheumatology department of the Würzburg university hospital, preferably but not limited to immunosuppressive therapy-naive patients.

06

What researchers measure

Primary outcomes

  1. Incidence of aortic adverse events

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

    Time frame: Within 5 years

Secondary outcomes

  1. Incidence of glucocorticoid-related adverse events

    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)

    Time frame: within 5 years

  2. Detection of ischemic complications in the eyes

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

    Time frame: within 5 years

  3. Performance of gadopiclenol in detecting vessel wall inflammation

    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.

    Time frame: within 5 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No — single center study

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07084480
Lead sponsor
Wuerzburg University Hospital
Responsible party
Sponsor
First posted
Jul 24, 2025
Start date
Nov 14, 2025
Primary completion
Jul 31, 2030 (estimated)
Completion
Jul 31, 2033 (estimated)
Last update
Dec 22, 2025

Study contacts

Michael Gernert
Contact
gernert_m1@ukw.de
+4993120140100
Hannah Labinsky
Contact
Labinsky_h@ukw.de
+4993120140100
Michael Gernert
principal investigator · Wuerzburg University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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