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Giant Cell Arteritis - Ways to Precision Medicine

W

Wuerzburg University Hospital

Status

Enrolling

Conditions

Giant Cell Arteritis
Polymyalgia Rheumatic (PMR)

Study type

Observational

Funder types

Other

Identifiers

NCT07084480
Riesenzellarteriitis-Register

Details and patient eligibility

About

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).

Full 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?

Enrollment

400 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

400 participants in 2 patient groups

Known patients
Description:
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
Description:
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.

Trial contacts and locations

1

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Central trial contact

Hannah Labinsky; Michael Gernert

Data sourced from clinicaltrials.gov

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