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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

149 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-21

Study Completion Date

2032-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Polymyalgia Rheumatica (PMR)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

PET/MRI

Intervention Type DIAGNOSTIC_TEST

PET/MRI at baseline and week 8

PET/CT with 18-FDG

Intervention Type DIAGNOSTIC_TEST

PET/CT in patients not receiving PET/MRI

Interventions

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PET/MRI

PET/MRI at baseline and week 8

Intervention Type DIAGNOSTIC_TEST

PET/CT with 18-FDG

PET/CT in patients not receiving PET/MRI

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Kresten Krarup Keller

Associate professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Kresten K Keller, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Rheumatology, Aarhus University Hospital

Locations

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Aarhus University Hospital

Aarhus, , Denmark

Site Status RECRUITING