Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NNF24OC0094827 | Other Grant/Funding Number | Novo Nordisk Foundation |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Randers Regional Hospital | OTHER |
| Central Jutland Regional Hospital | OTHER |
| Gødstrup Hospital | OTHER |
| Svendborg Hospital |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PET/MRI | Diagnostic Test | PET/MRI at baseline and week 8 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Baseline to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline |
| Clinical diagnosis of PMR after 1 year and a positive MRI at baseline. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients suspected of and diagnosed with polymyalgia rheumatica are included.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kresten K Keller, MD, PhD | Contact | +45 40384984 | krekel@rm.dk |
| Name | Affiliation | Role |
|---|---|---|
| Kresten K Keller, MD, PhD | Department of Rheumatology, Aarhus University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Recruiting | Aarhus | Denmark |
All IPD that underlie results in the publications
Starting 6 months after publication, and 2 years.
By resonably request.
Not provided
Not provided
| ID | Term |
|---|---|
| D011111 | Polymyalgia Rheumatica |
| D004194 | Disease |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000072078 | Positron Emission Tomography Computed Tomography |
| ID | Term |
|---|---|
| D049268 | Positron-Emission Tomography |
| D014055 | Tomography, Emission-Computed |
| D007090 | Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
Not provided
Not provided
| OTHER |
| Odense University Hospital | OTHER |
| Regionshospitalet Horsens | OTHER |
Not provided
Not provided
Not provided
Serum and plasma.
| PET/CT with 18-FDG | Diagnostic Test | PET/CT in patients not receiving PET/MRI |
|
Sensitivity and specificity of MRI at baseline for diagnosing PMR, using the clinical diagnosis at 1 year as reference standard. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline to 5 years |
| Gødstrup Hospital | Not yet recruiting | Gødstrup | Denmark |
| Horsens Regional Hospital | Not yet recruiting | Horsens | Denmark |
| Odense University Hospital | Not yet recruiting | Odense | Denmark |
| Randers Regional Hospital | Not yet recruiting | Randers | Denmark |
| Central Jutland Regional Hospital | Recruiting | Silkeborg | Denmark |
| Svendborg Hospital | Not yet recruiting | Svendborg | Denmark |
| D017437 | Skin and Connective Tissue Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D014057 | Tomography, X-Ray Computed |
| D064847 | Multimodal Imaging |
| D011856 | Radiographic Image Enhancement |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011859 | Radiography |
| D014056 | Tomography, X-Ray |
| D011877 | Radionuclide Imaging |
| D014054 | Tomography |
| D003947 | Diagnostic Techniques, Radioisotope |