Disease Activity Monitoring in Patients With Giant Cell Arteritis Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Giant Cell Arteritis (GCA). Basic parameters: from 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Disease Activity Monitoring in Patients With Giant Cell Arteritis
Overview
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.
Primary outcome measures
- Sensitivity and specificity of change in OGUS from inclusion to suspected relapse [Time frame: Within 10 months]
Secondary outcome measures (12)
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Denmark · 7 centers
- Aalborg University Hospital, Department of Rheumatology — Aalborg
- Aarhus University Hospital, Department of Rheumatology — Aarhus
- Rigshospitalet Glostrup, Center for Rheumatology and Spine Diseases Rigshospitalet — Glostrup Municipality
- Regional Hospital Horsens, Department of Medicine — Horsens
- Hospitalsenhed Midt, Medicinsk Diagnostisk Center — Silkeborg
- Svendborg Hospital, Department of Medicine — Svendborg
- Vejle Hospital, Department of Medicine — Vejle
Identifiers
NCT: NCT07552636 · DiAcMo · 10.46540/5333-00156B