Disease Activity Monitoring in Patients With Giant Cell Arteritis Study
ConditionGiant Cell Arteritis (GCA)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50+
SponsorUniversity of Aarhus
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Clinical GCA diagnosis established/confirmed by a rheumatologist and positive GCA imaging or biopsy at diagnosis < 3 years.
Clinical remission at the time of inclusion, defined as
Having adhered for ≥ 8 weeks prior to inclusion to either (a) the planned tapering of glucocorticoid therapy, or (b) the planned glucocorticoid-sparing DMARD treatment (with or without glucocorticoids).
Absence of, or no worsening of, symptoms attributed to GCA in ≥ 8 weeks.
Disqualifiers
Intra-articular, intravenous or intramuscular glucocorticoid ≤ 7 weeks prior to inclusion.
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
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.
Time frame
Within 10 monthsSecondary outcomes
1
Proportion of correctly classified relapse/non-relapse by vascular ultrasonography among participants with clinically uncertain relapse
Proportion of correctly classified relapse/non-relapse by vascular ultrasonography among participants with clinically uncertain relapse (Follow-up 1a) using the reassessment at Follow-up 2 as the reference standard. Key secondary.
Time frame
Within 10 months2
Predictive cut-off values of vascular ultrasonography scores at remission for relapse
The predictive cut-off values of vascular ultrasonography scores (OGUS and halo count) at remission (inclusion) for relapse within 12 months of inclusion using Follow-up 2 as the reference standard. Key secondary.
Time frame
12 months3
Change in GCA-PRO scores from remission to relapse
Change in Giant Cell Arteritis Patient Reported Outcome Measure (GCA-PRO) scores from remission (inclusion) to relapse (Follow-up 1a) using the reassessment at Follow-up 2 as reference standard. The total score for the GCA-PRO ranges from 0 to 90, where 0 indicates no impact on health-related quality of life (HRQoL) and 90 indicates high disease impact (poor HRQoL). Key secondary.
Time frame
Within 10 months4
Sensitivity and specificity of change in halo count from inclusion to suspected relapse
The sensitivity and specificity of change in halo count from remission (inclusion) to Follow-up 1a for relapse/non-relapse using the reassessment at Follow-up 2 as the reference standard.
Time frame
Within 10 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Aarhus
Lead sponsor
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
Source ClinicalTrials.gov