DANIsh VASculitis Database (DANIVAS) (DANIVAS)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Giant Cell Arteritis; Polymyalgia Rheumatica

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 Type: Observational
• Enrollment (Estimated): 3000

Contacts and Locations

• Study Contact: Name: Agnete Overgaard Donskov, MD; Phone Number: +4530225709; Email: agnead@rm.dk
• Study Contact Backup: Name: Kresten Krarup Keller, Ass prof; Email: kreskell@rm.dk

Study Locations

• Denmark
  • Aarhus, Denmark, 8200
    • Recruiting
    • Led og Bindevævssygdomme, Aarhus University Hospital
    • Contact: Kresten Krarup Keller, Ass Prof
  • Horsens, Denmark, 8700
    • Recruiting
    • Medicinsk klinik 2, Regionshospitalet Horsens
    • Contact: Berit Dalsgaard Nielsen, Ass Prof

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Aarhus University Hospital
• Collaborators: Odense University Hospital; Zealand University Hospital; Rigshospitalet, Denmark; Aalborg University Hospital; Holbaek Sygehus; Regionshospitalet Horsens; Hospital of South West Jutland
• Investigators: Principal Investigator: Berit Dalsgaard Nielsen, Ass prof, Led og Bindevæv, Aarhus University Hospital, Palle Juul-Jensens Boulevard 59, 8200 Aarhus N, DK

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2023
• Primary Completion (Estimated): December 31, 2034
• Study Completion (Estimated): December 31, 2051

Study Registration Dates

• First Submitted: June 1, 2023
• First Submitted That Met QC Criteria: June 28, 2023
• First Posted (Actual): July 7, 2023

Study Record Updates

• Last Update Posted (Estimated): January 24, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Skin Diseases; Immune System Diseases; Autoimmune Diseases of the Nervous System; Autoimmune Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Muscular Diseases; Vasculitis; Skin Diseases, Vascular; Vasculitis, Central Nervous System; Polymyalgia Rheumatica; Giant Cell Arteritis; Arteritis
• Other Study ID Numbers: DANIVAS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No