Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07010484

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Polymyalgia Rheumatica (PMR) Connective Tissue Diseases Disease Muscular Diseases Musculoskeletal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Polymyalgia Rheumatica Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aarhus University Hospital, Aarhus, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • Symptoms of GCA (headache, scalp tenderness, jaw or tongue claudication, vision disturbances attributable to GCA, limb claudication).
  • 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)
  • For MRI: Implants contraindicating MRI and BMI>150 kg.

Treatment and study plan

PET/MRI

Diagnostic Test

PET/MRI at baseline and week 8

PET/CT with 18-FDG

Diagnostic Test

PET/CT in patients not receiving PET/MRI

Primary outcomes

  1. 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.

    Time frame: Baseline

    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.

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

    Time frame: Baseline to 1 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.

Secondary outcomes

  1. Clinical diagnosis of PMR after 1 year and a positive [18F]FDG-PET/MRI at baseline.

    Time frame: Baseline

    Sensitivity and specificity of [18F]FDG-PET/MRI at baseline for diagnosing PMR, using the clinical diagnosis at 1 year as reference standard.

  2. Clinical diagnosis of PMR after 1 year and a positive MRI at baseline.

    Time frame: Baseline

    Sensitivity and specificity of MRI at baseline for diagnosing PMR, using the clinical diagnosis at 1 year as reference standard.

  3. 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.

    Time frame: Baseline

    Investigate if circular, focal and cylindrical [18F]FDG-uptake patterns correspond to synovitis, bursitis and tendinitis using MRI and ultrasound for confirmation.

  4. Clinical diagnosis of PMR after 1 year and synovitis, bursitis, and tendinitis/tenosynovits in the shoulders and hips.

    Time frame: Baseline

    Prevalence of synovitis, tendinitis/tenosynovitis and bursitis in PMR and differential diagnoses.

  5. Clinical diagnosis of PMR after 1 year and extra-capsular PMR diagnosed using [18F]FDG-PET/MRI.

    Time frame: Baseline

    Proportion of patients with capsular and extra-capsular PMR.

  6. Extra-capsular PMR and remission after 2 or 4 weeks.

    Time frame: Baseline to 4 weeks

    Time to remission in patients with extra-capsular involvement compared to PMR patients with capsular involvement.

  7. Extra-capsular PMR with relapse and remaining in prednisolone treatment within the first year, first 3 years, and first 5 years.

    Time frame: Baseline to 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.

  8. 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.

    Time frame: 8 weeks

    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.

  9. Clinical diagnosis of PMR after 1 year and a positive [18F]FDG-PET/MRI after 8 weeks of prednisolone treatment.

    Time frame: 8 weeks

    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.

  10. Clinical diagnosis of PMR after 1 year and a positive MRI after 8 weeks of prednisolone treatment.

    Time frame: 8 weeks

    Sensitivity and specificity of MRI after 8 weeks of prednisolone treatment for diagnosing PMR, using the clinical diagnosis at 1 year as reference standard.

  11. 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.

    Time frame: Baseline to 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.

  12. 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.

    Time frame: Baseline to 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.

  13. 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.

    Time frame: Baseline to 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.

  14. Baseline characteristics for patients with a positive PET scan and a clinical diagnosis of PMR at baseline.

    Time frame: 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.

  15. Baseline MRI findings for patients with a positive PET scan and a clinical diagnosis of PMR at baseline.

    Time frame: 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.

  16. 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.

    Time frame: Baseline to 1 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.

  17. 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.

    Time frame: Baseline to 5 years

    Prevalence of symptomatic and asymptomatic (subclinical) GCA at diagnosis, week 8, year 1, year 3 and year 5 in patients diagnosed with PMR.

  18. 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.

    Time frame: Baseline to 5 years

    Changes in ultrasound findings around the shoulders and hips during 1 year, 3 years and 5 years.

  19. Physical activity evaluated with step count using the physical activity tracking application over the course of one year in patients with PMR.

    Time frame: Baseline to 1 year

    Changes in physical activity during the first year after diagnosis.

  20. Decreased physical activity during doctor-diagnosed relapses of PMR.

    Time frame: Baseline to 1 year

    Investigate if relapses of PMR can be detected with physical activity tracking.

  21. Fulfilling the criteria for fibromyalgia at baseline and after 1, 3, and 5 years.

    Time frame: Baseline to 5 years

    Proportion of PMR patients fulfilling the criteria for fibromyalgia after 1 year, 3 years and 5 years.

Study contacts

Contact information is provided by the study sponsor or research team.

Kresten K Keller, MD, PhD

CONTACT

[email protected]

+45 40384984

Sponsors and collaborators

Lead sponsor

Kresten Krarup Keller

Other

Collaborators

  • Central Jutland Regional Hospital
  • Gødstrup Hospital
  • Odense University Hospital
  • Randers Regional Hospital
  • Regionshospitalet Horsens
  • Svendborg Hospital

Registry information

Acronym: REMAP PMR

Important dates

Study start
2025
Primary completion
2028
Study completion
2032
First posted
Jun 8, 2025
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.