Disease Activity Monitoring in Patients With Giant Cell Arteritis Study

NCT07552636 | Not Yet Recruiting

• 2 other identifiers: DiAcMo10.46540/5333-00156B
• Study Type: observational
• Target: 175
• Locations: 1 country
• Sites: 7

Brief Summary

Giant Cell Arteritis (GCA) is a vasculitis of medium- and large-sized arteries in older adults that may lead to serious vascular complications, including permanent vision loss and aortic aneurysm formation. Glucocorticoids are effective, but relapse during tapering is common and poses a major clinical challenge, potentially contributing to prolonged glucocorticoid exposure. Symptoms are often nonspecific and conventional inflammatory markers lack sufficient reliability, particularly in patients treated with drugs targeting the interleukin-6 pathway. Thus, this project aims to evaluate different tools assisting disease activity monitoring and/or predict future relapses and higher treatment requirements. Up to 175 patients with GCA in remission will be enrolled to ensure that 144 participants complete 1 year of follow-up. Participants undergo vascular ultrasonography, including double-blinded assessment at suspected relapse, complete patient-reported outcome measures, and provide biobank blood samples.

Conditions

Giant Cell Arteritis (GCA)

Keywords

vascular ultrasonography; disease activity monitoring; giant cell arteritis; patient-reported outcome measures

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity of change in OGUS from inclusion to suspected relapse

  Sensitivity and specificity of change in OMERACT Ultrasonography GCA Score (OGUS) from inclusion to suspected relapse (Follow-up 1a) for relapse/non-relapse using the reassessment at Follow-up 2 as the reference standard.

  Within 10 months

Secondary Outcomes (16)

• Proportion of correctly classified relapse/non-relapse by vascular ultrasonography among participants with clinically uncertain relapse

  Within 10 months

• Predictive cut-off values of vascular ultrasonography scores at remission for relapse

  12 months

• Change in GCA-PRO scores from remission to relapse

  Within 10 months

• Sensitivity and specificity of change in halo count from inclusion to suspected relapse

  Within 10 months

• Sensitivity and specificity of vascular ultrasonography scores at suspected relapse

  Within 10 months

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with giant cell arteritis (ICD-10: M31.5, M31.6) in clinical remission but still undergoing glucocorticoid tapering or tapering of glucocorticoid-sparing treatment.

You may qualify if:

• Clinical GCA diagnosis established/confirmed by a rheumatologist and positive GCA imaging or biopsy at diagnosis \< 3 years.
• Absence of, or no worsening of, symptoms attributed to GCA in ≥ 8 weeks.
• Current prednisolone dosage of ≥ 5 mg if glucocorticoid monotherapy.
• A continuous tapering of monotherapy or combination therapy is planned.
• Age \> 50 years.
• Study participants must be able to speak and understand spoken and written Danish.

You may not qualify if:

• Study participants who are unable to complete online questionnaires cannot participate in the GCA-PRO component of the study.
• Presence of cognitive impairment, including clinically significant dementia, that may interfere with the ability to provide informed consent or comply with study procedures.

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital: collaborator
• Aalborg University Hospital: collaborator
• Svendborg Hospital: collaborator
• Glostrup University Hospital, Copenhagen: collaborator
• Vejle Hospital: collaborator
• Horsens Hospital: collaborator
• Regionshospitalet Silkeborg: collaborator

Study Sites (7)

Aalborg University Hospital, Department of Rheumatology

Aalborg, 9000, Denmark

Location

Aarhus University Hospital, Department of Rheumatology

Aarhus, 8200, Denmark

Location

Rigshospitalet Glostrup, Center for Rheumatology and Spine Diseases Rigshospitalet

Glostrup Municipality, 2600, Denmark

Location

Regional Hospital Horsens, Department of Medicine

Horsens, 8700, Denmark

Location

Hospitalsenhed Midt, Medicinsk Diagnostisk Center

Silkeborg, 8600, Denmark

Location

Svendborg Hospital, Department of Medicine

Svendborg, 5700, Denmark

Location

Vejle Hospital, Department of Medicine

Vejle, 7100, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood biobank

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

Central Study Contacts

Morten Hansen, Medical Doctor

CONTACT

+45 20187463; mothas@rm.dk

Study Design

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

Study Record Dates

• First Submitted: April 20, 2026
• First Posted: April 27, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): February 1, 2029
• Last Updated: May 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After completion of the study.
• Access Criteria: By reasonably request.

Locations

DK (7)