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

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Diagnostic test
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Denmark
Aarhus University Hospital
RECRUITING
Aarhus
Gødstrup Hospital
NOT_YET_RECRUITING
Gødstrup
Horsens Regional Hospital
NOT_YET_RECRUITING
Horsens
Odense University Hospital
NOT_YET_RECRUITING
Odense
Randers Regional Hospital
NOT_YET_RECRUITING
Randers
Central Jutland Regional Hospital
RECRUITING
Silkeborg
Svendborg Hospital
NOT_YET_RECRUITING
Svendborg
Contact Information
Primary
Kresten K Keller, MD, PhD
krekel@rm.dk
+45 40384984
Time Frame
Start Date: 2025-08-21
Estimated Completion Date: 2032-08-31
Participants
Target number of participants: 149
Treatments
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.
Sponsors
Collaborators: Regionshospitalet Horsens, Central Jutland Regional Hospital, Gødstrup Hospital, Odense University Hospital, Svendborg Hospital, Randers Regional Hospital
Leads: Kresten Krarup Keller

This content was sourced from clinicaltrials.gov

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