Treat-to-target Prednisolon Taper in Patients With Polymyalgia Rheumatica
Key facts
- Who runs it
- Aarhus University Hospital
- Where
- Denmark6 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Active, not recruiting
- People taking part
- 120 people, planned
- Started
- 12 Jan 2023
- Expected to end
- Nov 2026
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Treat-to-target Prednisolone Taper
- Usual care
- Record updated
- 18 December 2025
Who can take part
- Age
- 50 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- 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
Who cannot take part
- Previous prednisolone treatment for GCA/PMR
- 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)
- Peroral, intraarticular or intramuscular application of glucocorticoids within the last month
- Unable to give consent
- Symptoms of GCA (newly onset-headache, tenderness of the temporal artery, jaw claudication, vision disturbances)
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Treat-to-target Prednisolone TaperExisting treatment, for comparison
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 CarePlacebo, for comparison
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.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Dose Reduction and Discontinuation of Prednisolone Using Structured Treat-to-target Taper in Patients With Polymyalgia Rheumatica
- Record updated
- 18 December 2025