DANIsh VASculitis Database (DANIVAS)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Giant Cell Arteritis, Polymyalgia Rheumatica. Basic parameters: from 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Disease Stratification in GCA and PMR to Inform Management and Reduce Disease and Treatment-related Damage
Overview
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).
Primary outcome measures
- Cumulative glucocorticoid doses compared between patients with cranial GCA and patients with Large Vessel-GCA [Time frame: From date of diagnosis with GCA until one year after. Assessed yearly up to 120 months]
Secondary outcome measures (3)
- Comparison of cumulative glucocorticoid doses in patients with pure PMR compared to PMR with subclinical LV-GCA [Time frame: 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 [Time frame: 2 years after diagnosis]
- Risk of aortic complications (aneurisms and dissections) in GCA patients with aortic involvement as compared to patients without aortic involvement. [Time frame: 2 years after diagnosis]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Denmark · 2 centers
- Led og Bindevævssygdomme, Aarhus University Hospital — Aarhus
- Medicinsk klinik 2, Regionshospitalet Horsens — Horsens
Publications
- Nielsen BD, Kristensen S, Donskov A, Terslev L, Dreyer LW, Colic A, Hetland ML, Hojgaard P, Ellingsen T, Hauge EM, Chrysidis S, Keller KK. The DANIsh VASculitis cohort study: protocol for a national multicenter prospective study including incident and prevalent patients with giant cell arteritis and polymyalgia rheumatica. Front Med (Lausanne). 2024 Jul 3;11:1415076. doi: 10.3389/fmed.2024.1415076 PMID 39026552
Identifiers
NCT: NCT05935709 · DANIVAS