Using Novel Imaging to Rethink Diagnostic and Treatment Strategies for Polymyalgia Rheumatica
Key facts
- Who runs it
- Kresten Krarup Keller
- Where
- Denmark7 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Recruiting
- People taking part
- 149 people, planned
- Started
- 21 Aug 2025
- Expected to end
- 31 Aug 2032
- Type of study
- Observational
- Treatments tested
- PET/MRI
- PET/CT with 18-FDG
- Record updated
- 1 October 2025
Who can take part
- Age
- 50 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 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
Who cannot take part
- Previous prednisolone treatment for GCA/PMR
- For MRI: Implants contraindicating MRI and BMI>150 kg
- Active malignant cancers within the last 5 years (except basal cell carcinoma)
- Other known inflammatory rheumatic diseases (e.g. rheumatoid arthritis, polymyositis, spondyloarthritis, psoriatic arthritis, gout)
- Uncontrolled diseases (e.g. severe active asthma, cardiac disease with NYHA class IV)
- Oral, intravenous, intra-articular or intramuscular glucocorticoids within the last 2 months
- Unable to give consent
- Proximal extremity pain duration for more than one year
- Symptoms of GCA (headache, scalp tenderness, jaw or tongue claudication, vision disturbances attributable to GCA, limb claudication)
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The group in the trial
- Patients with and suspected of polymyalgia rheumatica
The study 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 polymyalgia rheumatica (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 (estimated 64 from the 111 patients with suspected PMR, and additionally 38 diagnosed with PMR of which approximately 34 will have PMR without concurrent giant cell arteritis). Patients with a clinical diagnosis of PMR and a negative PET will not be started in routine treatment, but receive intramuscular glucocorticoids, which can be followed by oral prednisolone 15 mg tapered during a maximum of 3 month after diagnosis at discretion of the investigator.
Treatment: PET/MRI and PET/CT with 18-FDG
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 1 October 2025