DANIsh VASculitis Database (DANIVAS) — DANIVAS  

Giant Cell Arteritis Clinical Trial

Official title: Disease Stratification in GCA and PMR to Inform Management and Reduce Disease and Treatment-related Damage

Status Recruiting

Clinical Trial 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.

Clinical Trial 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). ;

Related Conditions & MeSH terms

• Arteritis
• Giant Cell Arteritis
• Polymyalgia Rheumatica

• NCT number: NCT05935709
• Study type: Observational [Patient Registry]
• Source: University of Aarhus
• Contact: Agnete Overgaard Donskov, MD
• Phone: +4530225709
• Email: agnead@rm.dk
• Status: Recruiting
• Start date: November 10, 2023
• Completion date: December 31, 2051