Treat-to-target Prednisolon Taper in Patients With Polymyalgia Rheumatica
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Treat-to-target Prednisolone Taper 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
Systematic prednisolone taper
|
| Placebo Comparator: Usual Care 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
Prednisolone taper performed by discretion of the patient's general practitioner.
|
Outcome Measures
Primary Outcome Measures
- Proportion of patients in prednisolone free remission 52 weeks from baseline [52 weeks]
Proportion of patients in prednisolone free remission 52 weeks from baseline
Secondary Outcome Measures
- Change in prednisolone dose from baseline to week 52 [52 weeks]
Change in prednisolone dose from baseline to week 52. Key secondary.
- Proportion of GCA patients diagnosed during the first 52 weeks [52 weeks]
Proportion of GCA patients diagnosed during the first 52 weeks. Key secondary
- Self-reported number of relapses during the first 52 weeks [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
- Change in patient-reported global visual analogue scale (VAS) from baseline to week 52 [52 weeks]
Change in patient-reported global VAS from baseline to week 52. Scale 0-10, 10 is worse. Key secondary
- Change in polymyalgia rheumatica activity score (PMR-AS) from baseline to week 52 [52 weeks]
Change in PMR-AS from baseline to week 52. scale 0-indefinitely. High score is worse. Secondary
- 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 [52 weeks]
Proportion of patients with an undiagnosed vasculitis assessed by ultrasound at week 52. Secondary
- Changes in short form (SF)-36 mental component summary (MCS) from baseline to week 52 [52 weeks]
Changes in SF-36 MCS from baseline to week 52. Secondary
- Changes in short form (SF)-36 physical component summary (PCS) from baseline to week 52 [52 weeks]
Changes in SF-36 PCS from baseline to week 52. Secondary
- Changes in health assessment questionnaire disability index (HAQ-DI) from baseline to week 52 [52 weeks]
Changes in HAQ-DI from baseline to week 52. High score is worse. Secondary
- Changes in patient reported polymyalgia rheumatica visual analog scale (PMR VAS) from baseline to week 52 [52 weeks]
Changes in patient reported PMR VAS from baseline to week 52. High score is worse. Secondary
- Changes in patient reported fatigue visal analog scale (VAS) from baseline to week 52 [52 weeks]
Changes in patient reported fatigue VAS from baseline to week 52. Higher is worse. Secondary
- Changes in patient reported stiffness visual analog scale (VAS) from baseline to week 52 [52 weeks]
Changes in patient reported stiffness VAS from baseline to week 52. Higher is worse. Secondary
- Changes in patient reported duration of morning stiffness from baseline to week 52 [52 weeks]
Changes in patient reported duration of morning stiffness from baseline to week 52. Secondary
- Proportion of patients where baseline DXA scan are performed during the first 3 months after baseline visit [3 months]
Proportion of patients where baseline DXA scan are performed during the first 3 months after baseline visit. Secondary
- Proportion of patients where HgbA1C blood samples are taken during the first 52 weeks [52 weeks]
Proportion of patients where HgbA1C blood samples are taken during the first 52 weeks. Secondary
- Frequency of patient reported adverse effects and comorbidities related to prednisolone treatment after 13, 26, 39 and 52 weeks [52 weeks]
Frequency of patient reported adverse effects and comorbidities related to prednisolone treatment after 13, 26, 39 and 52 weeks. Secondary.
- Proportion of patients with patient reported infections during the first 52 weeks [52 weeks]
Proportion of patients with patient reported infections during the first 52 weeks. Secondary.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients newly diagnosed with PMR according to the EULAR criteria for PMR.
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No sign of GCA on ultrasonography of the temporal and axillary arteries.
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Age over 50 years.
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Danish spoken and written language skills sufficient to fill out questionnaires.
Exclusion Criteria:
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Peroral, intraarticular or intramuscular application of glucocorticoids within the last month.
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Previous prednisolone treatment for GCA/PMR.
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Unable to give consent.
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Symptoms of GCA (newly onset-headache, tenderness of the temporal artery, jaw claudication, vision disturbances).
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Active malignant cancers within the last 5 years (except basal cell carcinoma).
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Other inflammatory rheumatic diseases (eg. rheumatoid arthritis, polymyositis, spondyloarthritis, psoriatic arthritits, gout).
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Uncontrolled diseases (eg severe active asthma, cardiac disease with NYHA class IV)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Aalborg University Hospital | Aalborg | Denmark | ||
| 2 | Aarhus University Hospital, Department of Rheumatology | Aarhus | Denmark | ||
| 3 | Esbjerg Regional Hospital | Esbjerg | Denmark | ||
| 4 | Gødstrup Regional Hospital | Herning | Denmark | ||
| 5 | Hjørring Regional Hospital | Hjørring | Denmark | ||
| 6 | Horsens Regional Hospital | Horsens | Denmark | ||
| 7 | Randers Regional Hospital | Randers | Denmark | ||
| 8 | Silkeborg Regional Hospital | Silkeborg | Denmark |
Sponsors and Collaborators
- Aarhus University Hospital
- Randers Regional Hospital
- Horsens Hospital
- Regionshospitalet Silkeborg
- Herning Hospital
- North Denmark Regional Hospital
- Aalborg University Hospital
- Hospital of South West Jutland
- Frederiksberg University Hospital
Investigators
- Principal Investigator: Kresten Keller, Aarhus University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- T2T PMR