Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
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 |
|
Secondary |
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 |
|
Secondary |
PMR diagnosis at week 10 with PET/CT |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
Change in PET/CT parameters from baseline to week |
Change in PET/CT parameters from baseline to week 8. |
8 weeks |
|
Secondary |
Change in PET/CT parameters from week 8 to week 10. |
Change in PET/CT parameters from week 8 to week 10. |
10 weeks |
|
Secondary |
Frequency of adrenal insufficiency at week 10. |
Frequency of adrenal insufficiency at week 10. |
10 weeks |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
Frequency of adrenal insufficiency |
Frequency of adrenal insufficiency after 1 and 1.5 years. |
18 months |
|
Secondary |
Lean boyd weight |
Lean body weight adjusted prednisolone dose as a predictor of adrenal insufficiency. |
18 months |
|
Secondary |
Hypercortisolism as predictor of adrenal insufficiency. |
Clinical and biochemical signs of hypercortisolism as predictor of adrenal insufficiency. |
18 months |
|
Secondary |
Change in clinical parameters week 8. |
Change in clinical parameters from baseline to week 8. |
8 weeks |
|
Secondary |
Change in clinical parameters week 10. |
Change in clinical parameters from week 8 to week 10. |
10 weeks |
|
Secondary |
Frequency of GCA |
Frequency of GCA at diagnosis and during follow up |
12 months |
|
Secondary |
Change in PROM's from baseline to week 8. |
Change in PROM's from baseline to week 8. |
8 weeks |
|
Secondary |
Change in PROM's from week 8 to week 10. |
Change in PROM's from week 8 to week 10. |
10 weeks |
|
Secondary |
Change in PROM's from baseline to 1 year. |
Change in PROM's from baseline to 1 year. |
12 months |
|
Secondary |
Sensitivity and specificity of CRP for PMR diagnosis at week 10. |
Sensitivity and specificity of CRP for PMR diagnosis at week 10. |
10 weeks |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
Percentage of patients receiving prednisolone after 3 and 5 years. |
Percentage of patients receiving prednisolone after 3 and 5 years. |
5 Years |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|