Giant Cell Arteritis - Ways to Precision Medicine

NCT07084480 | Recruiting

• 1 other identifier: Riesenzellarteriitis-Register
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Giant Cell Arteritis; Polymyalgia Rheumatic (PMR)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Incidence of aortic adverse events

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

  Within 5 years

Secondary Outcomes (3)

• Incidence of glucocorticoid-related adverse events

  within 5 years

• Detection of ischemic complications in the eyes

  within 5 years

• Performance of gadopiclenol in detecting vessel wall inflammation

  within 5 years

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• Age under 18 years
• lack of capacity to consent

Sponsors & Collaborators

• Wuerzburg University Hospital: lead

Study Sites (1)

Universitätsklinikum Würzburg

Würzburg, Germany

RECRUITING

MeSH Terms

Conditions

Giant Cell Arteritis

Condition Hierarchy (Ancestors)

Vasculitis, Central Nervous System; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arteritis; Vasculitis; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Michael Gernert

  Wuerzburg University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Gernert

CONTACT

+4993120140100; gernert_m1@ukw.de

Hannah Labinsky

CONTACT

+4993120140100; Labinsky_h@ukw.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2025
• First Posted: July 24, 2025
• Study Start: November 14, 2025
• Primary Completion (Estimated): July 31, 2030
• Study Completion (Estimated): July 31, 2033
• Last Updated: December 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)