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| Name | Class |
|---|---|
| Horsens Hospital | OTHER |
| Regionshospitalet Silkeborg | OTHER |
| Gødstrup Hospital | OTHER |
| Regionshospital Nordjylland |
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Polymyalgia rheumatica (PMR) has an incidence of approximately 1000/10^6 for persons more than 50 years. Treatment with prednisolone carries several significant adverse effects, and it is therefore essential to taper prednisolone as fast as possible. Systematic treatment strategies (treat-to-target) is the most important improvement of disease management for other rheumatic diseases such as rheumatoid arthritis in the last decades. Thus, the purpose is to investigate benefits and harms associated with a nurce led systematic prednisolone taper strategy at the department of rheumatology compared to individual treatment by discretion of the general practitioner. It is a 1-year open label randomised trial with a 1-year extension in 120 treatment naïve patients with PMR.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treat-to-target Prednisolone Taper | Active Comparator | Patients randomized to the "Treat-to-target" group is prescribed with a systematic prednisolone taper according to a specific scheme. The starting dose can be increased if remission is not reached initially or in case of relapse, folloved by taper according to the specific scheme. A nurse will make a minimum of 5 phone consultations the first year, and hereafter minimum every 3 months. |
|
| Usual Care | Placebo Comparator | Patients randomized to "usual care" are dismissed from the hospital after the diagnosis and the prednisolone taper are subsequently performed by discretion of the patient's general practitioner. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treat-to-target Prednisolone Taper | Other | Systematic prednisolone taper |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients in prednisolone free remission 52 weeks from baseline | Proportion of patients in prednisolone free remission 52 weeks from baseline | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in prednisolone dose from baseline to week 52 | Change in prednisolone dose from baseline to week 52. Key secondary. | 52 weeks |
| Proportion of GCA patients diagnosed during the first 52 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kresten Keller | Aarhus University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg University Hospital | Aalborg | Denmark | ||||
| Aarhus University Hospital, Department of Rheumatology |
All IPD that underlie results in the publications
Starting 6 months after publication, and 2 years.
By resonably request.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 8, 2022 | Oct 23, 2025 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 20, 2025 | Sep 26, 2025 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D011111 | Polymyalgia Rheumatica |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
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| OTHER_GOV |
| Aalborg University Hospital | OTHER |
| Frederiksberg University Hospital | OTHER |
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| Usual care | Other | Prednisolone taper performed by discretion of the patient's general practitioner. |
|
Proportion of GCA patients diagnosed during the first 52 weeks. Key secondary
| 52 weeks |
| Self-reported number of relapses during the first 52 weeks | Self-reported number of relapses during the first 52 weeks (assessed by increase in symptoms and an increase in prednisolone dosage). Key secondary | 52 weeks |
| Change in patient-reported global visual analogue scale (VAS) from baseline to week 52 | Change in patient-reported global VAS from baseline to week 52. Scale 0-10, 10 is worse. Key secondary | 52 weeks |
| Change in polymyalgia rheumatica activity score (PMR-AS) from baseline to week 52 | Change in PMR-AS from baseline to week 52. scale 0-indefinitely. High score is worse. Secondary | 52 weeks |
| Proportion of patients with an undiagnosed vasculitis assessed by ultrasound at week 52 Proportion of patients with an undiagnosed vasculitis assessed by ultrasound at week 52 | Proportion of patients with an undiagnosed vasculitis assessed by ultrasound at week 52. Secondary | 52 weeks |
| Changes in short form (SF)-36 mental component summary (MCS) from baseline to week 52 | Changes in SF-36 MCS from baseline to week 52. Secondary | 52 weeks |
| Changes in short form (SF)-36 physical component summary (PCS) from baseline to week 52 | Changes in SF-36 PCS from baseline to week 52. Secondary | 52 weeks |
| Changes in health assessment questionnaire disability index (HAQ-DI) from baseline to week 52 | Changes in HAQ-DI from baseline to week 52. High score is worse. Secondary | 52 weeks |
| Changes in patient reported polymyalgia rheumatica visual analog scale (PMR VAS) from baseline to week 52 | Changes in patient reported PMR VAS from baseline to week 52. High score is worse. Secondary | 52 weeks |
| Changes in patient reported fatigue visal analog scale (VAS) from baseline to week 52 | Changes in patient reported fatigue VAS from baseline to week 52. Higher is worse. Secondary | 52 weeks |
| Changes in patient reported stiffness visual analog scale (VAS) from baseline to week 52 | Changes in patient reported stiffness VAS from baseline to week 52. Higher is worse. Secondary | 52 weeks |
| Changes in patient reported duration of morning stiffness from baseline to week 52 | Changes in patient reported duration of morning stiffness from baseline to week 52. Secondary | 52 weeks |
| Proportion of patients where baseline DXA scan are performed during the first 3 months after baseline visit | Proportion of patients where baseline DXA scan are performed during the first 3 months after baseline visit. Secondary | 3 months |
| Proportion of patients where HgbA1C blood samples are taken during the first 52 weeks | Proportion of patients where HgbA1C blood samples are taken during the first 52 weeks. Secondary | 52 weeks |
| Frequency of patient reported adverse effects and comorbidities related to prednisolone treatment after 13, 26, 39 and 52 weeks | Frequency of patient reported adverse effects and comorbidities related to prednisolone treatment after 13, 26, 39 and 52 weeks. Secondary. | 52 weeks |
| Proportion of patients with patient reported infections during the first 52 weeks | Proportion of patients with patient reported infections during the first 52 weeks. Secondary. | 52 weeks |
| Aarhus |
| Denmark |
| Gødstrup Regional Hospital | Herning | Denmark |
| Hjørring Regional Hospital | Hjørring | Denmark |
| Horsens Regional Hospital | Horsens | Denmark |
| Silkeborg Regional Hospital | Silkeborg | Denmark |
| D017437 | Skin and Connective Tissue Diseases |