Actively Recruiting
Led by Aarhus University Hospital · Updated on 2024-01-24
3000
Participants Needed
2
Research Sites
887 weeks
Total Duration
A
Aarhus University Hospital
Lead Sponsor
R
Regionshospitalet Horsens
Collaborating Sponsor
Researchers are investigating whether new imaging methods can help classify giant cell arteritis (GCA) and polymyalgia rheumatica (PMR) to better predict how patients respond to treatment, their risk of relapse, and possible complications. This study aims to use these insights to guide treatment plans, improve disease control, and reduce damage caused by the disease or its treatment. It is a national observational study focused on patients with GCA and PMR, common inflammatory conditions in older adults. Participants will be enrolled at any stage of their disease and data will be collected through a national Danish database. The study will compare steroid treatment doses between different forms of GCA and between PMR patients with or without certain vascular involvement. Imaging with FDG-PET/CT and clinical data will be collected at various visits, such as enrollment, 2 months, 6 months, annually, and at 2 years after diagnosis. Blood samples will also be collected through a clinical biobank. During the study, data entry will occur at specified visits to track disease progress and treatment response. Researchers will monitor outcomes such as cumulative steroid doses and incidence of aortic dilatation or complications over time, with assessments up to 10 years. Regular audits will ensure data quality, and linkage with national medical registries will support comprehensive analysis. Participation involves clinical assessments, imaging, and blood sample collection following Danish guidelines.
CONDITIONS
DANIsh VASculitis Database (DANIVAS)
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants are enrolled and baseline clinical data including imaging and blood samples are collected and entered into the database.
1 enrollment visit (in-person)
Duration - 1 day
Participants have a response visit approximately 2 months after enrollment to assess disease status and update clinical data.
1 response visit (in-person) about 2 months after enrollment
Duration - 6 months for incident patients and annually thereafter for all participants
Participants attend routine follow-up visits to monitor disease progression and treatment according to national guidelines, with data entered into the database.
1 routine visit after 6 months for incident patients and annual visits thereafter
Duration - 1 day
Participants undergo a screening visit 2 years after diagnosis to assess long-term outcomes including imaging and clinical data collection.
1 screening visit at 2 years post diagnosis
Duration - 1 day
Participants who choose to withdraw have a final visit to document reasons and update clinical data.
1 withdrawal visit (if applicable)
Total: 2 locations
1
Led og Bindevævssygdomme, Aarhus University Hospital
Aarhus, Denmark, 8200
Actively Recruiting
2
Medicinsk klinik 2, Regionshospitalet Horsens
Horsens, Denmark, 8700
Actively Recruiting
A
Agnete Overgaard Donskov, MD
K
Kresten Krarup Keller, Ass prof
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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Berit D Nielsen, Salome Kristensen, Agnete Donskov...
https://pubmed.ncbi.nlm.nih.gov/39026552