DANIsh VASculitis Database (DANIVAS)

Giant Cell Arteritis Clinical Trial

— DANIVAS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05935709
• Other study ID #: DANIVAS
• Status: Recruiting
• Start date: November 10, 2023
• Est. completion date: December 31, 2051

Study information

• Verified date: April 2023
• Source: University of Aarhus
• Contact: Agnete Overgaard Donskov, MD
• Phone: +4530225709
• Email: agnead[@]rm.dk
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: December 31, 2051
• Est. primary completion date: December 31, 2034
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arteritis
• Giant Cell Arteritis
• Polymyalgia Rheumatica

Locations

Country	Name	City	State
Denmark	Led og Bindevævssygdomme, Aarhus University Hospital	Aarhus
Denmark	Medicinsk klinik 2, Regionshospitalet Horsens	Horsens

Sponsors (8)

Lead Sponsor	Collaborator
Aarhus University Hospital	Aalborg University Hospital, Holbaek Sygehus, Hospital of South West Jutland, Odense University Hospital, Regionshospitalet Horsens, Rigshospitalet, Denmark, Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative glucocorticoid doses compared between patients with cranial GCA and patients with Large Vessel-GCA	based on redeemed prescriptions	From date of diagnosis with GCA until one year after. Assessed yearly up to 120 months
Secondary	Comparison of cumulative glucocorticoid doses in patients with pure PMR compared to PMR with subclinical LV-GCA	based on redeemed prescriptions	From date of diagnosis with PMR until one year after. Assessed yearly up to 120 months
Secondary	Incidence of aortic dilatation in patients with c-GCA as compared to LV-GCA	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.	2 years after diagnosis
Secondary	Risk of aortic complications (aneurisms and dissections) in GCA patients with aortic involvement as compared to patients without aortic involvement.	The PET/CT scan at diagnosis compared to scan at year 2	2 years after diagnosis