Giant Cell Arteritis (GCA)DiAcMoNCT07552636
Disease Activity Monitoring in Patients With Giant Cell Arteritis Study
An observational study of Giant Cell Arteritis (GCA), run by University of Aarhus at 7 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Giant Cell Arteritis (GCA)
- How many people
- 175 participants
- Where
- 7 sitesDenmark
- Study dates
- 6 May 2026to Feb 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
- Normal CRP level (< 10 mg/L) within 7 days before inclusion.
- Current prednisolone dosage of ≥ 5 mg if glucocorticoid monotherapy.
Show all 9Show fewer
- 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.
Who cannot join
- 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 locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Denmark7 sites, 7 recruiting
- Not yet recruiting
Aalborg University Hospital, Department of Rheumatology
Aalborg, 9000
Salome Kristensen, MD, PhD, +45 97664015, sakr@rn.dk
- Recruiting
Aarhus University Hospital, Department of Rheumatology
Aarhus, 8200
Ellen Margrethe Hauge, MD, PhD, +45 2478 6025, ellen.hauge@aarhus.rm.dk
- Recruiting
Rigshospitalet Glostrup, Center for Rheumatology and Spine Diseases Rigshospitalet
Glostrup Municipality, 2600
Lene Terslev, MD, PhD, DMSc, +45 35454131, terslev@dadlnet.dk
- Recruiting
Regional Hospital Horsens, Department of Medicine
Horsens, 8700
Berit Dalsgaard Nielsen, MD, PhD, beritnel@rm.dk
- Not yet recruiting
Hospitalsenhed Midt, Medicinsk Diagnostisk Center
Silkeborg, 8600
Søren Geill Kjær, MD, +45 6171 7078, soekjaer@rm.dk
- Not yet recruiting
Svendborg Hospital, Department of Medicine
Svendborg, 5700
Bill Aplin Frederiksen, MD, +45 6320 2246, Bill.Aplin.Frederiksen@rsyd.dk
- Recruiting
Vejle Hospital, Department of Medicine
Vejle, 7100
Stavros Chrysidis, MD, PhD, +45 79409635, Stavros.Chrysidis@rsyd.dk
About this study
Official title: Disease Activity Monitoring in Patients With Giant Cell Arteritis
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
- Medical subject headings
- Giant Cell Arteritis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 10 months
Secondary outcomes (16)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2026
- Study start6 May 2026
- Primary completionMar 2028 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Giant Cell Arteritis (GCA)Studies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 175 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Aalborg University Hospital, Svendborg Hospital, Glostrup University Hospital, Copenhagen, Vejle Hospital, Horsens Hospital, Regionshospitalet Silkeborg
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07552636
- Sponsor's protocol ID
- DiAcMo
- Other IDs
- 10.46540/5333-00156B
- Acronym
- DiAcMo
- Status last verified
- May 2026
- First submitted
- 20 Apr 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in the publications.
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disease Activity Monitoring in Patients With Giant Cell Arteritis
- ClinicalTrials.gov ID
- NCT07552636
- Acronym / sponsor ID
- DiAcMo / DiAcMo
- Conditions
- Giant Cell Arteritis (GCA)
- Keywords
- vascular ultrasonography, disease activity monitoring, giant cell arteritis, patient-reported outcome measures
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 175 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Aalborg University Hospital, Svendborg Hospital, Glostrup University Hospital, Copenhagen, Vejle Hospital, Horsens Hospital, Regionshospitalet Silkeborg
- Study start
- 6 May 2026 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 27 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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
- Current prednisolone dosage of ≥ 5 mg if glucocorticoid monotherapy.
- A continuous tapering of monotherapy or combination therapy is planned.
- Age > 50 years.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity and specificity of change in OGUS from inclusion to suspected relapse
Time frame: Within 10 months
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.
16 secondary outcomes
Proportion of correctly classified relapse/non-relapse by vascular ultrasonography among participants with clinically uncertain relapse
Time frame: Within 10 months
Predictive cut-off values of vascular ultrasonography scores at remission for relapse
Time frame: 12 months
Change in GCA-PRO scores from remission to relapse
Time frame: Within 10 months
Sensitivity and specificity of change in halo count from inclusion to suspected relapse
Time frame: Within 10 months
Sensitivity and specificity of vascular ultrasonography scores at suspected relapse
Time frame: Within 10 months
Sensitivity and specificity of vascular ultrasonography scores for relapse/non-relapse in subgroups defined by OMERACT ultrasonography morphology
Time frame: Within 10 months
Change in probability of relapse and non-relapse before and after vascular ultrasonography
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
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
Time frame: 12 months
Time to relapse over 12 months in relation to vascular ultrasonography scores at inclusion
Time frame: 12 months
Change in GCA-PRO scores at relapse and 10 days after treatment escalation.
Time frame: Within 10 months
Convergence of GCA-PRO scores with other surrogate markers of disease activity from remission to relapse
Time frame: Within 10 months
Sensitivity and specificity of change in GCA-PRO scores from inclusion to suspected relapse
Time frame: Within 10 months
Sensitivity and specificity of GCA-PRO scores at suspected relapse
Time frame: Within 10 months
Relapse within 12 months evaluated in relation to GCA-PRO scores at inclusion.
Time frame: 12 months
Time to relapse over 12 months evaluated in relation to GCA-PRO scores at inclusion.
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in the publications.
Related trials for Giant Cell Arteritis (GCA)
Not yet recruitingPhase 3
Aspirin for the Prevention of Ischemic Complications in Giant Cell Arteritis
Giant Cell Arteritis (GCA), Acute Coronary Syndrome (ACS)
Not yet recruiting
Long-Axial Field of View (LAFOV) [18F]FDG PET/CT Imaging in Large Vessel Vasculitis (LVV): Protocol Optimisation Study.
Large Vessel Vasculitis, Takayasu Arteritis
RecruitingPhase 2
Tocilizumab Discontinuation Versus Dose Reduction for Patients With Well-Controlled Giant Cell Arteritis
Giant Cell Arteritis (GCA)
Not yet recruiting
Kinetics of C-Reactive Protein in Giant Cell Arteritis Following Glucocorticoid Initiation: A Pilot Study (GIDEON)
Giant Cell Arteritis (GCA)
Recruiting
Halo Sign Vanishing Time After Steroids Outbreak in GCA Patients
Giant Cell Arteritis (GCA), Doppler Ultrasound
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Giant Cell Arteritis (GCA), run by University of Aarhus at 7 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Morten Hansen, Medical Doctor (+45 20187463, mothas@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of change in OGUS from inclusion to suspected relapse (time frame: Within 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.