Actively Recruiting

Age: 50Years +
All Genders
NCT07010484

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

Led by Kresten Krarup Keller · Updated on 2025-10-01

149

Participants Needed

7

Research Sites

366 weeks

Total Duration

On this page

Sponsors

K

Kresten Krarup Keller

Lead Sponsor

R

Randers Regional Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 50Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients suspected of polymyalgia rheumatica seen at specified rheumatology or internal medicine departments
  • Age above 50 years
  • Presence of pain in the upper arms, shoulders, hips, or thighs
Not Eligible

You will not qualify if you...

  • Use of oral, intravenous, intra-articular, or intramuscular glucocorticoids within the last 2 months
  • Previous prednisolone treatment for giant cell arteritis or polymyalgia rheumatica
  • Unable to give informed consent
  • Pain in proximal extremities lasting more than one year
  • Symptoms of giant cell arteritis such as headache, scalp tenderness, jaw or tongue claudication, vision disturbances, or limb claudication
  • Active malignant cancers within the last 5 years except basal cell carcinoma
  • Presence of other inflammatory rheumatic diseases like rheumatoid arthritis, polymyositis, spondyloarthritis, psoriatic arthritis, or gout
  • Uncontrolled severe diseases such as severe active asthma or cardiac disease with NYHA class IV
  • Presence of implants that prevent MRI or body mass index over 150 kg for MRI eligibility

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 7 locations

1

Aarhus University Hospital

Aarhus, Denmark

Actively Recruiting

2

Gødstrup Hospital

Gødstrup, Denmark

Not Yet Recruiting

3

Horsens Regional Hospital

Horsens, Denmark

Not Yet Recruiting

4

Odense University Hospital

Odense, Denmark

Not Yet Recruiting

5

Randers Regional Hospital

Randers, Denmark

Not Yet Recruiting

6

Central Jutland Regional Hospital

Silkeborg, Denmark

Actively Recruiting

7

Svendborg Hospital

Svendborg, Denmark

Not Yet Recruiting

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Research Team

K

Kresten K Keller, MD, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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