Observing Disease Patterns and Treatment Effects in Giant Cell Arteritis and Polymyalgia Rheumatica in Denmark
Led by Aarhus University Hospital · Updated on 2024-01-24
3000
Participants Needed
2
Research Sites
887 weeks
Total Duration
AI-Summary
What this Trial Is About
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-PETCT 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
Brief Title
DANIsh VASculitis Database (DANIVAS)
Research Team
A
Agnete Overgaard Donskov, MD
K
Kresten Krarup Keller, Ass prof
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match. Sign up to get personalized trial recommendations delivered to your inbox.
Diagnosed with giant cell arteritis or polymyalgia rheumatica within the last 5 years
Diagnosis confirmed by a rheumatologist
Speak and understand Danish
Able to give signed and dated informed consent
You will not qualify if you...
Unable or unwilling to give informed consent
Diagnosed with other systemic autoimmune diseases that exclude giant cell arteritis or polymyalgia rheumatica diagnosis
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Enrollment and Baseline Data Entry
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)
Response Assessment
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
Routine Follow-up
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
Screening Visit at 2 Years
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
Withdrawal Visit
Duration - 1 day
Participants who choose to withdraw have a final visit to document reasons and update clinical data.
1 withdrawal visit (if applicable)
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
Similar Trials
Phase II Open-Label Study Comparing 18F-AzaFol and FDG PETCT Imaging for Diagnosing Giant Cell Arteritis in Adults Aged 50 and Older
Understanding the Impact of Rheumatic Immune-Related Side Effects After Immune Checkpoint Inhibitor Treatment
Phase 3 Trial of Weekly Subcutaneous Abatacept Versus Placebo in Adults Aged 50 and Older With Giant Cell Arteritis
Armenian Nationwide Registry for Patients with Systemic Autoimmune and Autoinflammatory Diseases
Tracking Disease Progress and Treatment Effects
Comprehensive Study of Biomarkers and Imaging for Diagnosis and Management of Giant Cell Arteritis and Polymyalgia Rheumatica
Study of Ultrasound Findings and Relapse in Adults with Giant Cell Arteritis
UK Study on Clinical and Genetic Features of Giant Cell Arteritis and Polymyalgia Rheumatica in Adults Over 50
Observing Disease Patterns and Treatment Effects in Giant Cell Arteritis and Polymyalgia Rheumatica in Denmark
Study on Supplemental Hydrocortisone During Stress for Patients Aged 50 and Older With Polymyalgia Rheumatica or Giant Cell Arteritis Taking Low-Dose Prednisolone
Long-Term Monitoring of Aortic and Glucocorticoid-Related Effects in Giant Cell Arteritis and Polymyalgia Rheumatica Patients
Have more questions? Get in touch with our team for quick support
Published Research Related To This Trial
The DANIsh VASculitis cohort study: protocol for a national multicenter prospective study including incident and prevalent patients with giant cell arteritis and polymyalgia rheumatica.
Berit D Nielsen, Salome Kristensen, Agnete Donskov...