An interventional study of Treat-to-target Prednisolone Taper and Usual care in Polymyalgia Rheumatica, sponsored by Aarhus University Hospital. Active, not recruiting at 6 sites in Denmark. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2025-12-18.
Sponsored by Aarhus University Hospital · Not applicable, Interventional, and Treatment
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.
68 studies on the registry are indexed under Polymyalgia Rheumatica; 22 are open to participants now.
This study's planned enrollment of 120 is above the median of 66 across 39 interventional studies indexed under Polymyalgia Rheumatica.
Browse Polymyalgia Rheumatica studies →Aarhus University Hospital is the lead sponsor of 298 studies on the registry; 80 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Treat-to-target Prednisolone Taper
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.
Other: Usual care
Systematic prednisolone taper
Prednisolone taper performed by discretion of the patient's general practitioner.
Proportion of patients in prednisolone free remission 52 weeks from baseline
Proportion of patients in prednisolone free remission 52 weeks from baseline
Time frame: 52 weeks
Change in prednisolone dose from baseline to week 52
Change in prednisolone dose from baseline to week 52. Key secondary.
Time frame: 52 weeks
Proportion of GCA patients diagnosed during the first 52 weeks
Proportion of GCA patients diagnosed during the first 52 weeks. Key secondary
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 52 weeks
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — All IPD that underlie results in the publications
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Starting 6 months after publication, and 2 years.
Access criteria: By resonably request.
Ran from Jan 2023 to primary completion in Oct 2025, 32 months.
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This study is active, not recruiting, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
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