DANIsh VASculitis Database (DANIVAS)

Recruiting

• Conditions: Giant Cell Arteritis; Polymyalgia Rheumatica

• Registration Number: NCT05935709
• Lead Sponsor: Aarhus University Hospital

Brief Summary

The aim of this national pragmatic observational study is to investigate whether the use of new diagnostic imaging modalities facilitates disease stratification that can potentially predict treatment response, relapse risk and complications and hence guide management strategies to improve disease control and reduce disease and treatment related damage.

Detailed Description

BACKGROUND Giant cell arteritis (GCA) is the most common vasculitis of the elderly. The concomitant disease polymyalgia rheumatica (PMR) is characterised by pain of the proximal muscles, general symptoms, and raised inflammatory markers. Only limited research has previously been performed nationally and internationally in GCA and PMR. To explore clinical practice, biomarkers, disease subsets, comorbidities, and long-term effectiveness of new treatments the establishment of large registries are highly warranted.

OBJECTIVES Primary objective: To compare cumulative GC doses in patients with c-GCA as compared to Large vessel (LV) -GCA

Key secondary objectives:

1. To compare cumulative GC doses in patients with pure PMR compared to PMR patients with subclinical LV-GCA

2. To compare the incidence of aortic dilatation 2 years after diagnosis in patients with c-GCA as compared to LV-GCA

3. In the subpopulation of patients whom a diagnostic Fluor-Deoxy-Glucose Positron Emissions Tomography ( FDG- PET)/CT was performed, to evaluate the risk of aortic complications (aneurisms and dissections) in GCA patients with aortic involvement as compared to patients without aortic involvement.

Once the database is established nationally, the database will be the basis for additional research projects in the future.

METHODS Using RedCap database infrastructure, clinical data including imaging will be documented in the individual Case Report Form developed by the project steering group.

The study population can be enrolled at any point during disease course and registered as either incidents ( up until 3 months from diagnosis) or prevalent. The treatment and follow up will be performed according to the National Danish GCA and PMR guidelines. At some of the visits data entry to the database will be performed: Enrollment visit, response visit(after 2 months), routine visit(after 6 months for incident patients and every year following), screening visit(2 years after diagnosis) and withdrawal visits. The aim is to include all rheumatic departments in Denmark.

Data audit to secure a high completeness will be performed regularly by a project manager the first two years and thereafter by a datamanager. Linkage of data across nationwide medical and administrative registries at the individual level will be performed. Blood samples will be collected by the infrastructure of the clinical biobank Danish ReumaBiobank (DRB).

Study Timeline

• Status Verified: 2023-04
• Study First Submitted: 2023-06-01
• Study First Submitted QC: 2023-06-28
• Study First Posted: 2023-07-07
• Study Start: 2023-11-10
• Last Update Submitted: 2024-01-22
• Last Update Posted: 2024-01-24
• Primary Completion: 2034-12-31
• Study Completion: 2051-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

• Are diagnosed with GCA or PMR within the last 5 years
• Diagnosis is established by or confirmed by a rheumatologist (clinical expert opinion)
• Speak and understand Danish
• Are able to give signed and dated informed consent

Exclusion Criteria

• Denies or are not able to give informed consent
• Are diagnosed with other systemic autoimmune diseases that out-rules the diagnosis of GCA or PMR

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cumulative glucocorticoid doses compared between patients with cranial GCA and patients with Large Vessel-GCA	From date of diagnosis with GCA until one year after. Assessed yearly up to 120 months	based on redeemed prescriptions

Secondary Outcome Measures

Name	Time	Method
Risk of aortic complications (aneurisms and dissections) in GCA patients with aortic involvement as compared to patients without aortic involvement.	2 years after diagnosis	The PET/CT scan at diagnosis compared to scan at year 2
Comparison of cumulative glucocorticoid doses in patients with pure PMR compared to PMR with subclinical LV-GCA	From date of diagnosis with PMR until one year after. Assessed yearly up to 120 months	based on redeemed prescriptions
Incidence of aortic dilatation in patients with c-GCA as compared to LV-GCA	2 years after diagnosis	Aortic dilatation is defined as diameters above the 90th percentile of the respective aortic region.The angiography can be performed as either CT or MR angiography and will be performed according to local set-up and imaging acquisition protocols.

Trial Locations

Locations (2)

Medicinsk klinik 2, Regionshospitalet Horsens; 🇩🇰 Horsens, Denmark

Led og Bindevævssygdomme, Aarhus University Hospital; 🇩🇰 Aarhus, Denmark