RecruitingNot Applicable

Using Novel Imaging to Rethink Diagnostic and Treatment Strategies for Polymyalgia Rheumatica

Denmark149 participantsStarted 2025-08-21

Plain-language summary

Polymyalgia rheumatica (PMR) is the most common chronic inflammatory rheumatic disease among the elderly and is characterized by proximal extremity pain and fatigue. Treatment with prednisolone carries several significant adverse effects, and it is therefore essential to avoid unnecessary treatment. However, clinical diagnosis and even imaging such as positron emission tomography and computed tomography (PET/CT) has low diagnostic accuracy, which decrease after start of prednisolone. The purpose is to evaluate a new method to diagnose PMR with PET/CT using magnetic resonance imaging (MRI) for informing the interpretation of PET in 111 patients suspected of PMR at baseline and after 8 weeks prednisolone treatment. In addition, a treatment initiation strategy guided by clinical diagnosis combined with PET will be evaluated in 100 patients with newly diagnosed PMR.

Who can participate

Age range

50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patients suspected of PMR seen at the Department of Rheumatology/internal medicine in Aarhus, Silkeborg, Horsens, Gødstrup, Randers, and Svendborg.
. Age above 50.
. Proximal extremity pain.

Exclusion criteria

. Oral, intravenous, intra-articular or intramuscular glucocorticoids within the last 2 months.
. Previous prednisolone treatment for GCA/PMR.
. Unable to give consent.
. Proximal extremity pain duration for more than one year.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Clinical diagnosis of PMR after 1 year and a positive baseline [18F]FDG-PET scan, with MRI findings used to support interpretation of the PET evaluation.

Timeframe: Baseline

A clinical diagnosis of PMR at baseline and a negative PET not requiring glucocorticoids for more than 3 months during the first year.

Timeframe: Baseline to 1 year

Trial details

NCT IDNCT07010484

SponsorKresten Krarup Keller

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-08-31

Contact for this trial

Kresten K Keller, MD, PhD

+45 40384984 krekel@rm.dk

View on ClinicalTrials.gov More Polymyalgia Rheumatica (PMR) trials