Disease Activity Monitoring in Patients With Giant Cell Arteritis Study

Официальное название

Disease Activity Monitoring in Patients With Giant Cell Arteritis

Обзор

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.

Первичные конечные точки

• Sensitivity and specificity of change in OGUS from inclusion to suspected relapse [Срок оценки: Within 10 months]

Вторичные конечные точки (12)

• Proportion of correctly classified relapse/non-relapse by vascular ultrasonography among participants with clinically uncertain relapse [Срок оценки: Within 10 months]
• Predictive cut-off values of vascular ultrasonography scores at remission for relapse [Срок оценки: 12 months]
• Change in GCA-PRO scores from remission to relapse [Срок оценки: Within 10 months]
• Sensitivity and specificity of change in halo count from inclusion to suspected relapse [Срок оценки: Within 10 months]
• Sensitivity and specificity of vascular ultrasonography scores at suspected relapse [Срок оценки: Within 10 months]
• Sensitivity and specificity of vascular ultrasonography scores for relapse/non-relapse in subgroups defined by OMERACT ultrasonography morphology [Срок оценки: Within 10 months]
• Change in probability of relapse and non-relapse before and after vascular ultrasonography [Срок оценки: Within 10 months]
• Time from suspected relapse to clinical conclusion in participants with clinically uncertain relapse that were correctly classified with vascular ultrasonography [Срок оценки: 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 [Срок оценки: 12 months]
• Time to relapse over 12 months in relation to vascular ultrasonography scores at inclusion [Срок оценки: 12 months]
• Change in GCA-PRO scores at relapse and 10 days after treatment escalation. [Срок оценки: Within 10 months]
• Convergence of GCA-PRO scores with other surrogate markers of disease activity from remission to relapse [Срок оценки: Within 10 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Дания · 7 центров

• 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

Идентификаторы

NCT: NCT07552636 · DiAcMo · 10.46540/5333-00156B

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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