NCT04519580

Improved Diagnostics and Monitoring of Polymyalgia Rheumatica

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 98 (actual)
• Sponsor: Kresten Krarup Keller · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Polymyalgia Rheumatica
• Giant Cell Arteritis
• Adrenal Insufficiency

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	PET/CT	FDG-PET/CT at baseline, week 8 and week 10.

Timeline

• Start date: 2020-09-14
• Primary completion: 2023-07-04
• Completion: 2027-06-30
• First posted: 2020-08-19
• Last updated: 2025-09-24

Locations

3 sites across 1 country: Denmark