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Recruiting NCT05636501

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

Conditions: Polymyalgia Rheumatica

Sex: All
Ages: 50 Years – N/A
Phase: NA
Enrollment: 120
Sponsor: Aarhus University Hospital

Location: Denmark

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.

Eligibility Criteria

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)

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05636501). StuddyBuddy aggregates publicly available trial information.