Clinical Trial

Improved Diagnostics and Monitoring of Polymyalgia Rheumatica

Active, Not Recruiting
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Summary
Background: Polymyalgia rheumatica (PMR) is characterised by pain of the proximal muscles, general symptoms, and raised inflammatory markers. Treatment with prednisolone has several adverse effects. PMR is an exclusion diagnosis, and methods to diagnose and monitor the disease are lacking. Objective: To investigate if ultrasound and PET/CT can be used to diagnose and monitor PMR. In addition, the importance of prednisolone induced adrenal insufficiency is investigated. Methods: It is a prospective observational study in patients suspected of PMR. Patients diagnosed with PMR continue in the study. Ultrasound and PET/CT are performed at baseline, after 8 weeks on prednisolone, and after 10 weeks during a short prednisolone break. Adrenal insufficiency is investigated five times throughout the study. After one year the PMR diagnosis is confirmed.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2020-08-17; most recent amendment 2025-09-19.
Status change: Recruiting → Active, Not Recruiting 2023-03-17
Trial Details
NCT Number NCT04519580
Lead Sponsor Kresten Krarup Keller
Collaborators: Aarhus University Hospital
Conditions Polymyalgia Rheumatica, Giant Cell Arteritis, Adrenal Insufficiency
Enrollment 98 participants
Start Date 2020-09-14
Primary Completion 2023-07-04 (estimated)
Study Completion 2027-06-30 (estimated)
Updated on ClinicalTrials.gov 2025-09-24