NCT04519580

Improved Diagnostics and Monitoring of Polymyalgia Rheumatica

Active, enrolled Last updated 24 September 2025

What this trial tests

trial testing PET/CT in Polymyalgia Rheumatica in 98 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

14 September 2020

Primary endpoint
4 July 2023

30 June 2027

Quick facts

Lead sponsor	Kresten Krarup Keller
Status	Active, enrolled
Study type	OBSERVATIONAL
Enrollment	98
Start date	14 September 2020
Primary completion	4 July 2023
Estimated completion	30 June 2027
Sites	3 locations across Denmark

Drugs / interventions tested

• PET/CT

Conditions studied

• Polymyalgia Rheumatica — all drugs for Polymyalgia Rheumatica →
• Giant Cell Arteritis — all drugs for Giant Cell Arteritis →
• Adrenal Insufficiency — all drugs for Adrenal Insufficiency →

Sponsor

Kresten Krarup Keller

Who can join

50 and older, any sex, with Polymyalgia Rheumatica or Giant Cell Arteritis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. The effect of prednisolone and a short-term prednisolone discontinuation for the diagnostic accuracy of FDG-PET/CT in polymyalgia rheumatica-a prospective study of 101 patients.
   Nielsen AW, Hansen IT, Nielsen BD, Kjær SG, et al · · 2024 · cited 20× · PMID 38563881 · DOI 10.1007/s00259-024-06697-8
2. Low incidence of late-onset giant cell arteritis during the first year in patients with polymyalgia rheumatica-a repeated imaging study.
   Nielsen AW, Hauge EM, Hansen IT, Nielsen BD, et al · · 2025 · cited 3× · PMID 39180419 · DOI 10.1093/rheumatology/keae463
3. Repeated short corticotropin testing in patients with polymyalgia rheumatica.
   Gaster T, Nielsen AW, Hansen SB, Donskov AO, et al · · 2026 · cited 1× · PMID 41264768 · DOI 10.1093/rheumatology/keaf614
4. Whole-body and site specific [<sup>18</sup>F]FDG uptake patterns on PET/CT have limited value in differentiating between polymyalgia rheumatica and other inflammatory diseases: two cohorts of treatment-naïve suspected polymyalgia rheumatica.
   Nielsen AW, van Praagh GD, van der Geest KSM, Hansen IT, et al · · 2025 · PMID 40307615 · DOI 10.1186/s13550-025-01233-7