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NCT Number: NCT07552636

Disease Activity Monitoring in Patients With Giant Cell Arteritis Study

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.

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Key information

Conditions

Giant Cell Arteritis (GCA) Arteritis Autoimmune Diseases Autoimmune Diseases of the Nervous System Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Giant Cell Arteritis Immune System Diseases Nervous System Diseases Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Vascular Diseases Vasculitis Vasculitis, Central Nervous System

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aalborg University Hospital, Department of Rheumatology, Aalborg, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

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

    Time frame: Within 10 months

    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.

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

    Time frame: 12 months

    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.

  3. Change in GCA-PRO scores from remission to relapse

    Time frame: Within 10 months

    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.

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

    Time frame: Within 10 months

    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.

  5. Sensitivity and specificity of vascular ultrasonography scores at suspected relapse

    Time frame: Within 10 months

    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.

  6. Sensitivity and specificity of vascular ultrasonography scores for relapse/non-relapse in subgroups defined by OMERACT ultrasonography morphology

    Time frame: Within 10 months

    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.

  7. Change in probability of relapse and non-relapse before and after vascular ultrasonography

    Time frame: Within 10 months

    Change in probability of relapse and non-relapse before and after vascular ultrasonography using clinician-rated pre-test probability and ultrasonography likelihood ratios.

  8. Time from suspected relapse to clinical conclusion in participants with clinically uncertain relapse that were correctly classified with vascular ultrasonography

    Time frame: 12 months

    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).

  9. 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

    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.

  10. Time to relapse over 12 months in relation to vascular ultrasonography scores at inclusion

    Time frame: 12 months

    Time to relapse over 12 months evaluated in relation to vascular ultrasonography scores at inclusion (remission).

  11. Change in GCA-PRO scores at relapse and 10 days after treatment escalation.

    Time frame: Within 10 months

    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).

  12. Convergence of GCA-PRO scores with other surrogate markers of disease activity from remission to relapse

    Time frame: Within 10 months

    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).

  13. Sensitivity and specificity of change in GCA-PRO scores from inclusion to suspected relapse

    Time frame: Within 10 months

    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).

  14. Sensitivity and specificity of GCA-PRO scores at suspected relapse

    Time frame: Within 10 months

    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).

  15. Relapse within 12 months evaluated in relation to GCA-PRO scores at inclusion.

    Time frame: 12 months

    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).

  16. Time to relapse over 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. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Morten Hansen, Medical Doctor

CONTACT

[email protected]

+45 20187463

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aalborg University Hospital
  • Aarhus University Hospital
  • Glostrup University Hospital, Copenhagen
  • Horsens Hospital
  • Regionshospitalet Silkeborg
  • Svendborg Hospital
  • Vejle Hospital

Registry information

Official study title

Disease Activity Monitoring in Patients With Giant Cell Arteritis

Acronym: DiAcMo

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Apr 27, 2026
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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