Polymyalgia Rheumatica (PMR)
Conditions
Keywords
polymyalgia rheumatica, imaging, diagnosis, PET/CT, PET/MRI
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.
Interventions
DIAGNOSTIC_TESTPET/MRI
PET/MRI at baseline and week 8
DIAGNOSTIC_TESTPET/CT with 18-FDG
PET/CT in patients not receiving PET/MRI
Sponsors
Randers Regional Hospital
Central Jutland Regional Hospital
Gødstrup Hospital
Svendborg Hospital
Odense University Hospital
Regionshospitalet Horsens
Kresten Krarup Keller
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
| A clinical diagnosis of PMR at baseline and a negative PET not requiring glucocorticoids for more than 3 months during the first year. | 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
| Measure | Time frame | Description |
|---|---|---|
| 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. | Baseline | Investigate if circular, focal and cylindrical \[18F\]FDG-uptake patterns correspond to synovitis, bursitis and tendinitis using MRI and ultrasound for confirmation. |
| Clinical diagnosis of PMR after 1 year and synovitis, bursitis, and tendinitis/tenosynovits in the shoulders and hips. | Baseline | Prevalence of synovitis, tendinitis/tenosynovitis and bursitis in PMR and differential diagnoses. |
| Clinical diagnosis of PMR after 1 year and extra-capsular PMR diagnosed using [18F]FDG-PET/MRI. | Baseline | Proportion of patients with capsular and extra-capsular PMR. |
| Extra-capsular PMR and remission after 2 or 4 weeks. | Baseline to 4 weeks | Time to remission in patients with extra-capsular involvement compared to PMR patients with capsular involvement. |
| Extra-capsular PMR with relapse and remaining in prednisolone treatment within the first year, first 3 years, and first 5 years. | 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. |
| 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. | 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. |
| Clinical diagnosis of PMR after 1 year and a positive [18F]FDG-PET/MRI after 8 weeks of prednisolone treatment. | 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. |
| Clinical diagnosis of PMR after 1 year and a positive MRI after 8 weeks of prednisolone treatment. | 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. |
| 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. | 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. |
| Clinical diagnosis of PMR after 1 year and a positive [18F]FDG-PET/MRI at baseline. | Baseline | Sensitivity and specificity of \[18F\]FDG-PET/MRI at baseline for diagnosing PMR, using the clinical diagnosis at 1 year as reference standard. |
| 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. | 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. |
| Baseline characteristics for patients with a positive PET scan and a clinical diagnosis of PMR at baseline. | 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. |
| Baseline MRI findings for patients with a positive PET scan and a clinical diagnosis of PMR at baseline. | 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. |
| 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. | 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. |
| 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. | 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. |
| 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. | Baseline to 5 years | Changes in ultrasound findings around the shoulders and hips during 1 year, 3 years and 5 years. |
| Physical activity evaluated with step count using the physical activity tracking application over the course of one year in patients with PMR. | Baseline to 1 year | Changes in physical activity during the first year after diagnosis. |
| Decreased physical activity during doctor-diagnosed relapses of PMR. | Baseline to 1 year | Investigate if relapses of PMR can be detected with physical activity tracking. |
| Fulfilling the criteria for fibromyalgia at baseline and after 1, 3, and 5 years. | Baseline to 5 years | Proportion of PMR patients fulfilling the criteria for fibromyalgia after 1 year, 3 years and 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. | 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. |
| Clinical diagnosis of PMR after 1 year and a positive MRI at baseline. | Baseline | Sensitivity and specificity of MRI at baseline for diagnosing PMR, using the clinical diagnosis at 1 year as reference standard. |
Countries
Denmark
Contacts
Primary ContactKresten K Keller, MD, PhD
Outcome results
None listed