Actively Recruiting
Predictive Factors for Treatment Response in Patients With Newly-diagnosed Polymyalgia Rheumatica and Giant Cell Arteritis
Led by University Hospital, Basel, Switzerland · Updated on 2025-04-01
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University Hospital, Basel, Switzerland
Lead Sponsor
S
Schweizerische Stiftung für die Erforschung der Muskelkrankheiten
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are exploring factors that predict how patients with newly diagnosed polymyalgia rheumatica (PMR) and giant cell arteritis (GCA) respond to steroid treatment. These related inflammatory diseases are typically treated with glucocorticoids (GCs), but individual responses vary widely. This study aims to understand the relationship between natural steroid hormone levels and treatment outcomes to help tailor therapies and reduce side effects like osteoporosis and infections. Participants with PMR will receive oral prednisone starting at 15 mg per day, tapered gradually as symptoms improve. Those with GCA will follow a guideline-based prednisone regimen starting at 1 mg per kg of body weight and tapering to zero by 26 weeks. Biological samples will be collected at three points: after initial prednisone treatment, during tapering, and after stopping steroids, to analyze cellular responses, hormone levels, and steroid metabolism. Throughout the study, clinical data will be recorded in a database, tracking relapses, cumulative steroid doses, use of additional immunosuppressive treatments, and steroid-related toxicity. The primary outcome is whether patients experience relapse within one year of diagnosis. Various laboratory measurements and correlations will help identify steroid response profiles, with the total study duration extending up to one year after diagnosis.
CONDITIONS
Brief Title
Predictive Factors for Treatment Response in Patients With Newly-diagnosed Polymyalgia Rheumatica and Giant Cell Arteritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with polymyalgia rheumatica according to the 2012 provisional classification criteria
- Patients diagnosed with giant cell arteritis according to published criteria
- Consent to participate in the SCQM database
- Treatment according to standardized steroid regimens
You will not qualify if you...
- Treatment with Tocilizumab, methotrexate, or other disease modifying medications at the time of inclusion
- History of polymyalgia rheumatica or giant cell arteritis in the past
- Inability to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year after diagnosis
Participants who undergo routine care with standardized steroid regimens are observed to explore predictive factors for treatment response in PMR and GCA.
Multiple visits according to routine clinical care and biosampling at three specific time-points during steroid treatment
Trial Site Locations
Total: 1 location
1
Department of Rheumatology University Hospital Basel
Basel, Switzerland, 4031
Actively Recruiting
Research Team
T
Thomas Daikeler, Prof. Dr. med.
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
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