An observational study in Giant Cell Arteritis (GCA), sponsored by University of Aarhus. Recruiting at 7 sites in Denmark. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-08-31.
Sponsored by University of Aarhus · Observational
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.
147 studies on the registry are indexed under Giant Cell Arteritis; 49 are open to participants now.
This study's planned enrollment of 175 is above the median of 128 across 78 observational studies indexed under Giant Cell Arteritis.
Browse Giant Cell Arteritis studies →University of Aarhus is the lead sponsor of 1,300 studies on the registry; 189 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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.
Clinical remission at the time of inclusion, defined as
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 months
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 months
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 months
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 months
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 months
Sensitivity and specificity of vascular ultrasonography scores at suspected relapse
The sensitivity and specificity of US scores (OMERACT Ultrasonography GCA Score and halo count) at suspected relapse (Follow-up 1) for relapse/non-relapse using the reassessment at Follow-up 2 as the reference standard.
Time frame: Within 10 months
Sensitivity and specificity of vascular ultrasonography scores for relapse/non-relapse in subgroups defined by OMERACT ultrasonography morphology
The sensitivity and specificity of vascular ultrasonography scores for relapse/non-relapse in subgroups defined by OMERACT US morphology (normal, active vasculitis, chronic vasculitis, atherosclerotic) using the reassessment at Follow-up 2 as the reference standard.
Time frame: Within 10 months
Change in probability of relapse and non-relapse before and after vascular ultrasonography
Change in probability of relapse and non-relapse before and after vascular ultrasonography using clinician-rated pre-test probability and ultrasonography likelihood ratios.
Time frame: Within 10 months
Time from suspected relapse to clinical conclusion in participants with clinically uncertain relapse that were correctly classified with vascular ultrasonography
The time (potentially saved) from suspected relapse (Follow-up 1a) to clinical conclusion (relapse review) in participants with clinically uncertain relapse that were correctly classified with vascular ultrasonography compared to the reference standard (Follow-up 2).
Time frame: 12 months
Number of supplementary tests ordered at suspected relapse to clinical conclusion in participants with clinically uncertain relapses/non-relapse that were correctly classified by vascular ultrasonography
The number of supplementary tests ordered at suspected relapse (Follow-up 1a) to clinical conclusion (relapse review) in participants with clinically uncertain relapses/non-relapse that were correctly classified by vascular ultrasonography using the reassessment at Follow-up 2 as the reference standard.
Time frame: 12 months
Time to relapse over 12 months in relation to vascular ultrasonography scores at inclusion
Time to relapse over 12 months evaluated in relation to vascular ultrasonography scores at inclusion (remission).
Time frame: 12 months
Change in GCA-PRO scores at relapse and 10 days after treatment escalation.
Change in GCA-PRO scores at relapse and 10 days after treatment escalation. The total score for the GCA-PRO ranges from 0 to 90, where 0 indicates no impact on HRQoL and 90 indicates high disease impact (poor HRQoL).
Time frame: Within 10 months
Convergence of GCA-PRO scores with other surrogate markers of disease activity from remission to relapse
Convergence of GCA-PRO scores with, respectively, c-reactive protein levels, patient and physician global activity numeric rating scale scores, and vascular ultrasonography scores (halo count and OGUS) from remission (inclusion) to relapse (Follow-up 1a). The total score for the GCA-PRO ranges from 0 to 90, where 0 indicates no impact on HRQoL and 90 indicates high disease impact (poor HRQoL).
Time frame: Within 10 months
Sensitivity and specificity of change in GCA-PRO scores from inclusion to suspected relapse
The sensitivity and specificity of change in GCA-PRO scores from inclusion to suspected relapse (Follow-up 1a) for relapse/non-relapse using the reassessment at Follow-up 2 as the reference standard. The total score for the GCA-PRO ranges from 0 to 90, where 0 indicates no impact on HRQoL and 90 indicates high disease impact (poor HRQoL).
Time frame: Within 10 months
Sensitivity and specificity of GCA-PRO scores at suspected relapse
The sensitivity and specificity of GCA-PRO scores at suspected relapse (Follow-up 1a) for relapse/non-relapse using the reassessment at Follow-up 2 as the reference standard. The total score for the GCA-PRO ranges from 0 to 90, where 0 indicates no impact on HRQoL and 90 indicates high disease impact (poor HRQoL).
Time frame: Within 10 months
Relapse within 12 months evaluated in relation to GCA-PRO scores at inclusion.
Relapse within 12 months evaluated in relation to GCA-PRO scores at inclusion. The total score for the GCA-PRO ranges from 0 to 90, where 0 indicates no impact on HRQoL and 90 indicates high disease impact (poor HRQoL).
Time frame: 12 months
Time to relapse over 12 months evaluated in relation to GCA-PRO scores at inclusion.
Time to relapse over 12 months evaluated in relation to GCA-PRO scores at inclusion. The total score for the GCA-PRO ranges from 0 to 90, where 0 indicates no impact on HRQoL and 90 indicates high disease impact (poor HRQoL).
Time frame: 12 months
Plan to share: Yes — All IPD that underlie results in the publications.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: After completion of the study.
Access criteria: By reasonably request.
No publications or documents are linked to this record.
Started May 2026 (actual). Primary completion is estimated for Mar 2028, 22 months after the start.
Of 44 observational studies under Giant Cell Arteritis, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 33 and three quarters within 164. This study's planned 22 months is below that.
How these figures are worked out, and which studies are left out of them.
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