Using Novel Imaging to Rethink Diagnostic and Treatment Strategies for Polymyalgia Rheumatica (REMAP PMR)

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.

Study Overview

• Status: Recruiting
• Conditions: Polymyalgia Rheumatica (PMR)
• Intervention / Treatment: Diagnostic test: PET/MRI; Diagnostic test: PET/CT with 18-FDG

• Study Type: Observational
• Enrollment (Estimated): 149

Contacts and Locations

• Study Contact: Name: Kresten K Keller, MD, PhD; Phone Number: +45 40384984; Email: krekel@rm.dk

Study Locations

• Denmark
  • Aarhus, Denmark
    • Recruiting
    • Aarhus University Hospital
    • Contact: Kresten K Keller
  • Gødstrup, Denmark
    • Not yet recruiting
    • Gødstrup Hospital
  • Horsens, Denmark
    • Not yet recruiting
    • Horsens Regional Hospital
  • Odense, Denmark
    • Not yet recruiting
    • Odense University Hospital
  • Randers, Denmark
    • Not yet recruiting
    • Randers Regional Hospital
  • Silkeborg, Denmark
    • Recruiting
    • Central Jutland Regional Hospital
  • Svendborg, Denmark
    • Not yet recruiting
    • Svendborg Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients suspected of and diagnosed with polymyalgia rheumatica are included.

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Oral, intravenous, intra-articular or intramuscular glucocorticoids within the last 2 months.
2. Previous prednisolone treatment for GCA/PMR.
3. Unable to give consent.
4. Proximal extremity pain duration for more than one year.
5. Symptoms of GCA (headache, scalp tenderness, jaw or tongue claudication, vision disturbances attributable to GCA, limb claudication).
6. Active malignant cancers within the last 5 years (except basal cell carcinoma).
7. Other known inflammatory rheumatic diseases (e.g. rheumatoid arthritis, polymyositis, spondyloarthritis, psoriatic arthritis, gout).
8. Uncontrolled diseases (e.g. severe active asthma, cardiac disease with NYHA class IV)
9. For MRI: Implants contraindicating MRI and BMI>150 kg.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Diagnostic test: PET/MRI; PET/MRI at baseline and week 8; Diagnostic test: PET/CT with 18-FDG; PET/CT in patients not receiving PET/MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	sensitivity and specificity of [18F]FDG-PET/CT using PET combined with MRI to inform the interpretation of the PET evaluation, using the clinical diagnosis at 1 year as reference standard.	Baseline
A clinical diagnosis of PMR at baseline and a negative PET not requiring glucocorticoids for more than 3 months during the first year.	proportion of patients with a positive clinical diagnosis and a negative PET not requiring glucocorticoids for more than 3 months during the first year.	Baseline to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical diagnosis of PMR after 1 year and a positive [18F]FDG-PET/MRI at baseline.	Sensitivity and specificity of [18F]FDG-PET/MRI at baseline for diagnosing PMR, using the clinical diagnosis at 1 year as reference standard.	Baseline
Clinical diagnosis of PMR after 1 year and a positive MRI at baseline.	Sensitivity and specificity of MRI at baseline for diagnosing PMR, using the clinical diagnosis at 1 year as reference standard.	Baseline
Circular, focal, and/or cylindrical [18F]FDG-uptake patterns associated to synovitis, bursitis, and tendinitis/tenosynovitis in the shoulders and hips on MRI or ultrasound.	Investigate if circular, focal and cylindrical [18F]FDG-uptake patterns correspond to synovitis, bursitis and tendinitis using MRI and ultrasound for confirmation.	Baseline
Clinical diagnosis of PMR after 1 year and synovitis, bursitis, and tendinitis/tenosynovits in the shoulders and hips.	Prevalence of synovitis, tendinitis/tenosynovitis and bursitis in PMR and differential diagnoses.	Baseline
Clinical diagnosis of PMR after 1 year and extra-capsular PMR diagnosed using [18F]FDG-PET/MRI.	Proportion of patients with capsular and extra-capsular PMR.	Baseline
Extra-capsular PMR and remission after 2 or 4 weeks.	Time to remission in patients with extra-capsular involvement compared to PMR patients with capsular involvement.	Baseline to 4 weeks
Extra-capsular PMR with relapse and remaining in prednisolone treatment within the first year, first 3 years, and first 5 years.	Proportion of patients with capsular and extra-capsular PMR who experience relapse and remain in prednisolone treatment within the first year, first 3 years, and first 5 years.	Baseline to 5 years
Clinical diagnosis of PMR after 1 year and a positive [18F]FDG-PET/CT after 8 weeks of prednisolone treatment, with MRI findings used to support PET interpretation.	Sensitivity and specificity of [18F]FDG-PET after 8 weeks of prednisolone treatment using PET combined with MRI to inform the interpretation of PET scans for diagnosing PMR, using the clinical diagnosis at 1 year as reference standard.	8 weeks
Clinical diagnosis of PMR after 1 year and a positive [18F]FDG-PET/MRI after 8 weeks of prednisolone treatment.	Sensitivity and specificity of [18F]FDG-PET/MRI after 8 weeks of prednisolone treatment for diagnosing PMR, using the clinical diagnosis at 1 year as reference standard.	8 weeks
Clinical diagnosis of PMR after 1 year and a positive MRI after 8 weeks of prednisolone treatment.	Sensitivity and specificity of MRI after 8 weeks of prednisolone treatment for diagnosing PMR, using the clinical diagnosis at 1 year as reference standard.	8 weeks
Specific baseline clinical information and baseline, 8 weeks, or changes after 8 weeks of prednisolone treatment on [18F]FDG-PET/MRI findings, and the prediction of relapse and prednisolone-free remission after 1 year, 3 years, and 5 years.	Investigate whether clinical information or [18F]FDG-PET/MRI findings at baseline, 8 weeks, or changes after 8 weeks of prednisolone treatment can predict relapse and prednisolone-free remission after 1 year, 3 years, and 5 years.	Baseline to 5 years
Specific baseline clinical information and baseline, 8 weeks, or changes after 8 weeks of prednisolone treatment on MRI findings, and the prediction of relapse and prednisolone-free remission after 1 year, 3 years, and 5 years.	Investigate whether clinical information or MRI findings at baseline, 8 weeks, or changes after 8 weeks of prednisolone treatment can predict relapse and prednisolone-free remission after 1 year, 3 years, and 5 years.	Baseline to 5 years
Specific baseline clinical information and baseline, 8 weeks, or changes after 8 weeks of prednisolone treatment on ultrasonography findings, and the prediction of relapse and prednisolone-free remission after 1 year, 3 years, and 5 years.	Investigate whether clinical information and ultrasonography findings at baseline, 8 weeks, or changes after 8 weeks of prednisolone treatment can predict relapse and prednisolone-free remission after 1 year, 3 years, and 5 years.	Baseline to 5 years
Baseline characteristics for patients with a positive PET scan and a clinical diagnosis of PMR at baseline.	Compare baseline characteristics between patients with a positive PET scan and a clinical diagnosis of PMR and those with a negative PET scan and a clinical diagnosis of PMR.	Baseline
Baseline MRI findings for patients with a positive PET scan and a clinical diagnosis of PMR at baseline.	Compare MRI findings between patients with a positive PET scan and a clinical diagnosis of PMR and those with a negative PET scan and a clinical diagnosis of PMR.	Baseline
Baseline characteristics for patients with a clinical diagnosis of PMR at baseline and a negative PET scan not receiving glucocorticoids for more than 3 months during the first year.	Investigate if baseline characteristics can predict which patients with a clinical PMR diagnosis will have a negative PET and require glucocorticoids for no longer than 3 months during the first year.	Baseline to 1 year
Clinical diagnosis of PMR after 1 year and symptomatic or asymptomatic (subclinical) GCA at diagnosis, week 8, year 1, year 3, and year 5 in patients diagnosed with PMR.	Prevalence of symptomatic and asymptomatic (subclinical) GCA at diagnosis, week 8, year 1, year 3 and year 5 in patients diagnosed with PMR.	Baseline to 5 years
Clinical diagnosis of PMR after 1 year and positive ultrasound findings around the shoulders and hips at baseline, week 8, year 1, year 3, and year 5.	Changes in ultrasound findings around the shoulders and hips during 1 year, 3 years and 5 years.	Baseline to 5 years
Physical activity evaluated with step count using the physical activity tracking application over the course of one year in patients with PMR.	Changes in physical activity during the first year after diagnosis.	Baseline to 1 year
Decreased physical activity during doctor-diagnosed relapses of PMR.	Investigate if relapses of PMR can be detected with physical activity tracking.	Baseline to 1 year
Fulfilling the criteria for fibromyalgia at baseline and after 1, 3, and 5 years.	Proportion of PMR patients fulfilling the criteria for fibromyalgia after 1 year, 3 years and 5 years.	Baseline to 5 years

Collaborators and Investigators

• Sponsor: Kresten Krarup Keller
• Collaborators: Odense University Hospital; Gødstrup Hospital; Svendborg Hospital; Regionshospitalet Horsens; Randers Regional Hospital; Central Jutland Regional Hospital
• Investigators: Principal Investigator: Kresten K Keller, MD, PhD, Department of Rheumatology, Aarhus University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2025
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2032

Study Registration Dates

• First Submitted: May 30, 2025
• First Submitted That Met QC Criteria: May 30, 2025
• First Posted (Actual): June 8, 2025

Study Record Updates

• Last Update Posted (Estimated): October 1, 2025
• Last Update Submitted That Met QC Criteria: September 26, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: imaging; PET/CT; diagnosis; PET/MRI; polymyalgia rheumatica
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Muscular Diseases; Pathologic Processes; Rheumatic Diseases; Connective Tissue Diseases; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Disease; Polymyalgia Rheumatica; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Diagnostic Imaging; Radiography; Image Interpretation, Computer-Assisted; Radiographic Image Enhancement; Image Enhancement; Photography; Tomography, X-Ray; Tomography, Emission-Computed; Radionuclide Imaging; Diagnostic Techniques, Radioisotope; Positron-Emission Tomography; Tomography, X-Ray Computed; Multimodal Imaging; Positron Emission Tomography Computed Tomography
• Other Study ID Numbers: 1-10-72-69-25; NNF24OC0094827 (Other Grant/Funding Number: Novo Nordisk Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD that underlie results in the publications
• IPD Sharing Time Frame: Starting 6 months after publication, and 2 years.
• IPD Sharing Access Criteria: By resonably request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No