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 Type
OBSERVATIONAL
Enrollment
149
PET/MRI at baseline and week 8
PET/CT in patients not receiving PET/MRI
Aarhus University Hospital
Aarhus, Denmark
RECRUITINGGødstrup Hospital
Gødstrup, Denmark
NOT_YET_RECRUITINGHorsens Regional Hospital
Horsens, Denmark
NOT_YET_RECRUITINGOdense University Hospital
Odense, Denmark
NOT_YET_RECRUITINGRanders Regional Hospital
Randers, Denmark
NOT_YET_RECRUITINGCentral Jutland Regional Hospital
Silkeborg, Denmark
RECRUITINGSvendborg Hospital
Svendborg, Denmark
NOT_YET_RECRUITINGClinical 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.
Time frame: 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.
Time frame: Baseline to 1 year
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to 5 years
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