Clinical trial NCT07010484: Using Novel Imaging to Rethink Diagnostic and Treatment Strategies for Polymyalgia Rheumatica
Official title: Using Novel Imaging to Rethink Diagnostic and Treatment Strategies for Polymyalgia Rheumatica
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Polymyalgia Rheumatica (PMR)
Keywords: polymyalgia rheumatica
imaging
diagnosis
PET/CT
PET/MRI
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
Collaborators: name: Randers Regional Hospital
name: Central Jutland Regional Hospital
name: Gødstrup Hospital
name: Svendborg Hospital
name: Odense University Hospital
name: Regionshospitalet Horsens
First posted: 2025-06-08
Enrollment: 149
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients suspected of and diagnosed with polymyalgia rheumatica are included.

Brief 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 criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: Baseline
measure: A clinical diagnosis of PMR at baseline and a negative PET not requiring glucocorticoids for more than 3 months during the first year.
timeFrame: Baseline to 1 year
Secondary outcomes:
measure: Clinical diagnosis of PMR after 1 year and a positive [18F]FDG-PET/MRI at baseline.
timeFrame: Baseline
measure: Clinical diagnosis of PMR after 1 year and a positive MRI at baseline.
timeFrame: Baseline
measure: 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.
timeFrame: Baseline
measure: Clinical diagnosis of PMR after 1 year and synovitis, bursitis, and tendinitis/tenosynovits in the shoulders and hips.
timeFrame: Baseline
measure: Clinical diagnosis of PMR after 1 year and extra-capsular PMR diagnosed using [18F]FDG-PET/MRI.
timeFrame: Baseline
measure: Extra-capsular PMR and remission after 2 or 4 weeks.
timeFrame: Baseline to 4 weeks
measure: Extra-capsular PMR with relapse and remaining in prednisolone treatment within the first year, first 3 years, and first 5 years.
timeFrame: Baseline to 5 years
measure: 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.
timeFrame: 8 weeks
measure: Clinical diagnosis of PMR after 1 year and a positive [18F]FDG-PET/MRI after 8 weeks of prednisolone treatment.
timeFrame: 8 weeks
measure: Clinical diagnosis of PMR after 1 year and a positive MRI after 8 weeks of prednisolone treatment.
timeFrame: 8 weeks
measure: 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.
timeFrame: Baseline to 5 years
measure: 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.
timeFrame: Baseline to 5 years
measure: 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.
timeFrame: Baseline to 5 years
measure: Baseline characteristics for patients with a positive PET scan and a clinical diagnosis of PMR at baseline.
timeFrame: Baseline
measure: Baseline MRI findings for patients with a positive PET scan and a clinical diagnosis of PMR at baseline.
timeFrame: Baseline
measure: 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.
timeFrame: Baseline to 1 year
measure: 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.
timeFrame: Baseline to 5 years
measure: 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.
timeFrame: Baseline to 5 years
measure: Physical activity evaluated with step count using the physical activity tracking application over the course of one year in patients with PMR.
timeFrame: Baseline to 1 year
measure: Decreased physical activity during doctor-diagnosed relapses of PMR.
timeFrame: Baseline to 1 year
measure: Fulfilling the criteria for fibromyalgia at baseline and after 1, 3, and 5 years.
timeFrame: Baseline to 5 years
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Gødstrup
country: Denmark
facility: Gødstrup Hospital
city: Horsens
country: Denmark
facility: Horsens Regional Hospital
city: Odense
country: Denmark
facility: Odense University Hospital
city: Randers
country: Denmark
facility: Randers Regional Hospital
city: Silkeborg
country: Denmark
facility: Central Jutland Regional Hospital
city: Svendborg
country: Denmark
facility: Svendborg Hospital
Study officials:
affiliation: Department of Rheumatology, Aarhus University Hospital
name: Kresten K Keller, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: