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| Name | Class |
|---|---|
| Aarhus University Hospital | OTHER |
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Background: Polymyalgia rheumatica (PMR) is characterised by pain of the proximal muscles, general symptoms, and raised inflammatory markers. Treatment with prednisolone has several adverse effects. PMR is an exclusion diagnosis, and methods to diagnose and monitor the disease are lacking.
Objective: To investigate if ultrasound and PET/CT can be used to diagnose and monitor PMR. In addition, the importance of prednisolone induced adrenal insufficiency is investigated.
Methods: It is a prospective observational study in patients suspected of PMR. Patients diagnosed with PMR continue in the study. Ultrasound and PET/CT are performed at baseline, after 8 weeks on prednisolone, and after 10 weeks during a short prednisolone break. Adrenal insufficiency is investigated five times throughout the study. After one year the PMR diagnosis is confirmed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with suspected polymyalgia rheumatica | The study investigates patients with suspected polymyalgia rheumatica (PMR). For Patients where the PMR diagnosis is dismissed, the study terminates after the first visit. Patients diagnosed with PMR will be treated with prednisolone with taper corresponding to usual care. At baseline all patients will have medical history taken, physical examination, blood drawn, Synacthen® test, PET/CT, and ultrasound performed. Physical examination, PET/CT, and ultrasound are repeated after 8 weeks of prednisolone treatment while the patients iare on 10 mg prednisolone as well as after prednisolone taper two weeks later, where Synachten® test is also performed. After 10 weeks prednisolone is restarted at 10 mg and the patient is followed by their general practitioner or at the department of rheumatology, where prednisolone is tapered according to usual care. Patients are invited to a follow up visit after one year. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PET/CT | Diagnostic Test | FDG-PET/CT at baseline, week 8 and week 10. |
|
| Measure | Description | Time Frame |
|---|---|---|
| PMR diagnosis at baseline with PET/CT | Sensitivity and specificity of PET/CT for PMR diagnosis at baseline with the clinical diagnosis after 1 year as reference standard and patients not diagnosed with PMR serving as controls. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| PMR diagnosis at week 8 with PET/CT | Sensitivity and specificity of PET/CT for PMR diagnosis at week 8 with the clinical diagnosis after 1 year as reference standard and patients not diagnosed with PMR serving as controls. | 8 weeks |
| PMR diagnosis at week 10 with PET/CT |
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Inclusion Criteria:
Exclusion Criteria:
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The study will include patients suspected for PMR.
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| Name | Affiliation | Role |
|---|---|---|
| Kresten Keller, MD | Department of Rheumatology, Aarhus University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Rheumatology, Aarhus University Hospital | Aarhus | 8200 | Denmark | |||
| Department of Rheumatology, Horsens Regional Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41264768 | Derived | Gaster T, Nielsen AW, Hansen SB, Donskov AO, Nielsen MK, Hansen IT, Nielsen BD, Kjaer SG, Blegvad-Nissen J, Moller Sorensen C, Hauge EM, Jorgensen JOL, Keller KK. Repeated short corticotropin testing in patients with polymyalgia rheumatica. Rheumatology (Oxford). 2026 Feb 4;65(2):keaf614. doi: 10.1093/rheumatology/keaf614. | |
| 40307615 |
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| ID | Term |
|---|---|
| D011111 | Polymyalgia Rheumatica |
| D013700 | Giant Cell Arteritis |
| D000309 | Adrenal Insufficiency |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000072078 | Positron Emission Tomography Computed Tomography |
| D014463 | Ultrasonography |
| ID | Term |
|---|---|
| D049268 | Positron-Emission Tomography |
| D014055 | Tomography, Emission-Computed |
| D007090 | Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
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whole blood, plasma, serum
Sensitivity and specificity of PET/CT for PMR diagnosis after one week of discontinuation of glucocorticoids (week 10) with the clinical diagnosis after 1 year as reference standard and patients not diagnosed with PMR serving as controls. |
| 10 weeks |
| Change in Ultrasound parameters from baseline to week 8 | Change in presence and thickness of subdeltoid bursitis and biceps tenosynovitis from baseline to week 8. | 8 weeks |
| Change in Ultrasound parameters from week 8 to week 10 | Change in presence and thickness of subdeltoid bursitis and biceps tenosynovitis from week 8 to week 10. | 10 weeks |
| Change in PET/CT parameters from baseline to week | Change in PET/CT parameters from baseline to week 8. | 8 weeks |
| Change in PET/CT parameters from week 8 to week 10. | Change in PET/CT parameters from week 8 to week 10. | 10 weeks |
| Frequency of adrenal insufficiency at week 10. | Frequency of adrenal insufficiency at week 10. | 10 weeks |
| Presence of adrenal insufficiency at week 10 as a predictor of prednisolone cessation at one year. | Presence of adrenal insufficiency at week 10 as a predictor of prednisolone cessation at one year. | 12 months |
| Presence of adrenal insufficiency at week 10 as a predictor of relapse at week 10. | Presence of adrenal insufficiency at week 10 as a predictor of relapse at week 10. | 10 weeks |
| Frequency of adrenal insufficiency | Frequency of adrenal insufficiency after 1 and 1.5 years. | 18 months |
| Lean boyd weight | Lean body weight adjusted prednisolone dose as a predictor of adrenal insufficiency. | 18 months |
| Hypercortisolism as predictor of adrenal insufficiency. | Clinical and biochemical signs of hypercortisolism as predictor of adrenal insufficiency. | 18 months |
| Change in clinical parameters week 8. | Change in clinical parameters from baseline to week 8. | 8 weeks |
| Change in clinical parameters week 10. | Change in clinical parameters from week 8 to week 10. | 10 weeks |
| Frequency of GCA | Frequency of GCA at diagnosis and during follow up | 12 months |
| Change in PROM's from baseline to week 8. | Change in PROM's from baseline to week 8. | 8 weeks |
| Change in PROM's from week 8 to week 10. | Change in PROM's from week 8 to week 10. | 10 weeks |
| Change in PROM's from baseline to 1 year. | Change in PROM's from baseline to 1 year. | 12 months |
| Sensitivity and specificity of CRP for PMR diagnosis at week 10. | Sensitivity and specificity of CRP for PMR diagnosis at week 10. | 10 weeks |
| Level of inflammatory markers in PMR patients at baseline vs. week 8. | Level of inflammatory markers in PMR patients at baseline vs. week 8. | 8 weeks |
| Level of inflammatory markers in PMR patients vs. non PMR patients at baseline. | Level of inflammatory markers in PMR patients vs. non PMR patients at baseline. | Baseline |
| Change in expression levels of clock gene mRNA as marker of prednisolone-induced changes in sleep, lipid levels and glycated hemoglobin. | Change in expression levels of clock gene mRNA as marker of prednisolone-induced changes in sleep, lipid levels and glycated hemoglobin. | 1 year |
| Percentage of patients with concomitant GCA and PMR after 3 and 5 years. | Percentage of patients with concomitant GCA and PMR after 3 and 5 years. | 5 Years |
| Percentage of patients receiving prednisolone after 3 and 5 years. | Percentage of patients receiving prednisolone after 3 and 5 years. | 5 Years |
| PET/CT measures at baseline as a predictor of prednisolone treatment after 3 and 5 years. | PET/CT measures at baseline is measured with Standard Uptake Value and dichrotone evaluation for PMR (PMR +/-) | 5 Years |
| Changes in PET/CT parameters from baseline to week 8 as predictor of prednisolone treatment after 3 and 5 years | PET/CT changes from baseline to 8 weeks in Standard Uptake Value and dichrotone evaluation for PMR (PMR +/-) will be evaluated. | 5 Years |
| Adrenal insufficiency as a predictor of prednisolone treatment after 3 and 5 years. | Adrenal insufficiency (+/-) will be evaluated with synachten test 4-5 times during the first 1,5 year of the study. At least one positive value will contribute to the parameter. | 5 Years |
| Changes in US findings from baseline to week 8 as predictor of prednisolone treatment after 3 and 5 years | Ultrasound dichrotone changes from baseline to week 8 will be evaluated (positive/negative for bursitis/artritis) | 5 Years |
| Horsens |
| 8700 |
| Denmark |
| Diagnostic Centre, Silkeborg Regional Hospital | Silkeborg | 8600 | Denmark |
| Nielsen AW, van Praagh GD, van der Geest KSM, Hansen IT, Nielsen BD, Kjaer SG, Blegvad-Nissen J, Rewers K, Sorensen CM, Brouwer E, Hauge EM, Gormsen LC, Slart RHJA, Keller KK. Whole-body and site specific [18F]FDG uptake patterns on PET/CT have limited value in differentiating between polymyalgia rheumatica and other inflammatory diseases: two cohorts of treatment-naive suspected polymyalgia rheumatica. EJNMMI Res. 2025 Apr 30;15(1):51. doi: 10.1186/s13550-025-01233-7. |
| 40131424 | Derived | Vaben CS, Nielsen AW, Nielsen MK, Moll LT, Mork C, Dalgaard EB, Rasmussen TK, Ostgard RD, Hansen IT, Nielsen BD, Sorensen CM, Blegvad-Nissen J, Kjaer SG, Hauge EM, Keller KK. The effect of prednisolone initiation and short-term discontinuation on the clinical assessment of polymyalgia rheumatica. Rheumatology (Oxford). 2025 Aug 1;64(8):4756-4760. doi: 10.1093/rheumatology/keaf170. |
| 39180419 | Derived | Nielsen AW, Hauge EM, Hansen IT, Nielsen BD, Kjaer SG, Blegvad J, Rewers K, Moller Sorensen C, Gormsen LC, Keller KK. Low incidence of late-onset giant cell arteritis during the first year in patients with polymyalgia rheumatica-a repeated imaging study. Rheumatology (Oxford). 2025 Apr 1;64(4):2193-2198. doi: 10.1093/rheumatology/keae463. |
| 38563881 | Derived | Nielsen AW, Hansen IT, Nielsen BD, Kjaer SG, Blegvad-Nissen J, Rewers K, Sorensen CM, Hauge EM, Gormsen LC, Keller KK. The effect of prednisolone and a short-term prednisolone discontinuation for the diagnostic accuracy of FDG-PET/CT in polymyalgia rheumatica-a prospective study of 101 patients. Eur J Nucl Med Mol Imaging. 2024 Jul;51(9):2614-2624. doi: 10.1007/s00259-024-06697-8. Epub 2024 Apr 2. |
| D017437 | Skin and Connective Tissue Diseases |
| D020293 | Vasculitis, Central Nervous System |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001167 | Arteritis |
| D014657 | Vasculitis |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000307 | Adrenal Gland Diseases |
| D004700 | Endocrine System Diseases |
| 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 |