Clinical trial NCT05935709: DANIsh VASculitis Database (DANIVAS)
Official title: Disease Stratification in GCA and PMR to Inform Management and Reduce Disease and Treatment-related Damage
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Giant Cell Arteritis
Polymyalgia Rheumatica
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Regionshospitalet Horsens
name: Aalborg University Hospital
name: Odense University Hospital
name: Esbjerg Hospital - University Hospital of Southern Denmark
name: Holbaek Sygehus
name: Rigshospitalet, Denmark
name: Zealand University Hospital
First posted: 2023-07-07
Enrollment: 3000
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients can be included at any time during the disease course. Patients will be registered as either incident (newly diagnosed within the last 3 months) or prevalent (included during routine follow-up \> 3 months after diagnosis) cases.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Cumulative glucocorticoid doses compared between patients with cranial GCA and patients with Large Vessel-GCA
timeFrame: From date of diagnosis with GCA until one year after. Assessed yearly up to 120 months
Secondary outcomes:
measure: Comparison of cumulative glucocorticoid doses in patients with pure PMR compared to PMR with subclinical LV-GCA
timeFrame: From date of diagnosis with PMR until one year after. Assessed yearly up to 120 months
measure: Incidence of aortic dilatation in patients with c-GCA as compared to LV-GCA
timeFrame: 2 years after diagnosis
measure: Risk of aortic complications (aneurisms and dissections) in GCA patients with aortic involvement as compared to patients without aortic involvement.
timeFrame: 2 years after diagnosis
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Led og Bindevævssygdomme, Aarhus University Hospital
city: Horsens
country: Denmark
facility: Medicinsk klinik 2, Regionshospitalet Horsens
Study officials:
affiliation: Led og Bindevæv, Aarhus University Hospital, Palle Juul-Jensens Boulevard 59, 8200 Aarhus N, DK
name: Berit Dalsgaard Nielsen, Ass prof
role: PRINCIPAL_INVESTIGATOR
References: