Not provided
Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 10.46540/5333-00156B | Other Grant/Funding Number | Independent Research Fund Denmark |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Aarhus University Hospital | OTHER |
| Aalborg University Hospital | OTHER |
| Svendborg Hospital | OTHER |
| Glostrup University Hospital, Copenhagen |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within 10 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within 10 months |
Not provided
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
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:
Not provided
Not provided
Not provided
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Morten Hansen, Medical Doctor | Contact | +45 20187463 | mothas@rm.dk |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg University Hospital, Department of Rheumatology | Not yet recruiting | Aalborg | 9000 | Denmark |
All IPD that underlie results in the publications.
After completion of the study.
By reasonably request.
Not provided
Not provided
| ID | Term |
|---|---|
| D013700 | Giant Cell Arteritis |
| ID | Term |
|---|---|
| D020293 | Vasculitis, Central Nervous System |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D002561 | Cerebrovascular Disorders |
Not provided
Not provided
| OTHER |
| Vejle Hospital | OTHER |
| Horsens Hospital | OTHER |
| Regionshospitalet Silkeborg | OTHER |
Not provided
Not provided
Not provided
Blood biobank
| 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. | 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. | 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. | 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. | 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. | 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. | 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). | 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. | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 12 months |
| Aarhus University Hospital, Department of Rheumatology | Not yet recruiting | Aarhus | 8200 | Denmark |
|
| Rigshospitalet Glostrup, Center for Rheumatology and Spine Diseases Rigshospitalet | Not yet recruiting | Glostrup Municipality | 2600 | Denmark |
|
| Regional Hospital Horsens, Department of Medicine | Recruiting | Horsens | 8700 | Denmark |
|
| Hospitalsenhed Midt, Medicinsk Diagnostisk Center | Not yet recruiting | Silkeborg | 8600 | Denmark |
|
| Svendborg Hospital, Department of Medicine | Not yet recruiting | Svendborg | 5700 | Denmark |
|
| Vejle Hospital, Department of Medicine | Not yet recruiting | Vejle | 7100 | Denmark |
|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001167 | Arteritis |
| D014657 | Vasculitis |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |