Treat-to-target Prednisolon Taper in Patients With Polymyalgia Rheumatica

Study Overview
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Brief Summary
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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.

Official Title
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Dose Reduction and Discontinuation of Prednisolone Using Structured Treat-to-target Taper in Patients With Polymyalgia Rheumatica

Conditions
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Polymyalgia Rheumatica

Intervention / Treatment
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* Other: Treat-to-target Prednisolone Taper
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients newly diagnosed with PMR according to the EULAR criteria for PMR. No sign of GCA on ultrasonography of the temporal and axillary arteries. Age over 50 years. Danish spoken and written language skills sufficient to fill out questionnaires. Exclusion Criteria: Peroral, intraarticular or intramuscular application of glucocorticoids within the last month. Previous prednisolone treatment for GCA/PMR. Unable to give consent. Symptoms of GCA (newly onset-headache, tenderness of the temporal artery, jaw claudication, vision disturbances). Active malignant cancers within the last 5 years (except basal cell carcinoma). Other inflammatory rheumatic diseases (eg. rheumatoid arthritis, polymyositis, spondyloarthritis, psoriatic arthritits, gout). Uncontrolled diseases (eg severe active asthma, cardiac disease with NYHA class IV)

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treat-to-target Prednisolone Taper<br>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<br>* Systematic prednisolone taper<br>|
| Placebo Comparator: Usual Care<br>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<br>* Prednisolone taper performed by discretion of the patient's general practitioner.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |