Disease Stratification in GCA and PMR to Inform Management and Reduce Disease and Treatment-related Damage
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 3,000
- Locations
- 2
- Primary Endpoint
- Cumulative glucocorticoid doses compared between patients with cranial GCA and patients with Large Vessel-GCA
Study Overview
Brief Summary
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:
- To compare cumulative GC doses in patients with pure PMR compared to PMR patients with subclinical LV-GCA
- To compare the incidence of aortic dilatation 2 years after diagnosis in patients with c-GCA as compared to LV-GCA
- 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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
based on redeemed prescriptions
Secondary Outcomes
- Risk of aortic complications (aneurisms and dissections) in GCA patients with aortic involvement as compared to patients without aortic involvement.(2 years after diagnosis)
- Comparison of cumulative glucocorticoid doses in patients with pure PMR compared to PMR with subclinical LV-GCA(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(2 years after diagnosis)