DANIsh VASculitis Database (DANIVAS)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50+
SponsorAarhus University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Cumulative glucocorticoid doses compared between patients with cranial GCA and patients with Large Vessel-GCA
based on redeemed prescriptions
Time frame
From date of diagnosis with GCA until one year after. Assessed yearly up to 120 monthsSecondary outcomes
1
Comparison of cumulative glucocorticoid doses in patients with pure PMR compared to PMR with subclinical LV-GCA
based on redeemed prescriptions
Time frame
From date of diagnosis with PMR until one year after. Assessed yearly up to 120 months2
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.
Time frame
2 years after diagnosis3
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
Time frame
2 years after diagnosisSponsors and contacts
Click on the lead sponsor to view all of their trials.
Aarhus University Hospital
Lead sponsor
Regionshospitalet Horsens
Collaborator
Aalborg University Hospital
Collaborator
Odense University Hospital
Collaborator
Esbjerg Hospital - University Hospital of Southern Denmark
Collaborator
Holbaek Sygehus
Collaborator
Rigshospitalet, Denmark
Collaborator
Zealand University Hospital
Collaborator
Source ClinicalTrials.gov