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

NCT05636501 · tracked via the Priya Life Science Denmark tracker

Sponsor

Aarhus University Hospital

Phase

Not applicable

Started

2023-01-12

Last updated

2025-12-18

Condition(s) studied

Polymyalgia Rheumatica

Investigational drug(s) / intervention(s)

Treat-to-target Prednisolone TaperUsual care

Treat-to-target Prednisolone Taper: Systematic prednisolone taper

Usual care: Prednisolone taper performed by discretion of the patient's general practitioner.

Study 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

Sex

ALL

Min age

50 Years

Max age

—

Healthy volunteers

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)

Primary outcome measure(s)

Proportion of patients in prednisolone free remission 52 weeks from baseline — 52 weeks
Proportion of patients in prednisolone free remission 52 weeks from baseline

Trial sites (6)

Facility	City	Region
Aalborg University Hospital	Aalborg	Denmark
Aarhus University Hospital, Department of Rheumatology	Aarhus	Denmark
Gødstrup Regional Hospital	Herning	Denmark
Hjørring Regional Hospital	Hjørring	Denmark
Horsens Regional Hospital	Horsens	Denmark
Silkeborg Regional Hospital	Silkeborg	Denmark

More Aarhus University Hospital trials in Denmark

Clinical Utility of ctDNA in the Treatment of Oligometastatic Disease Starting soon

Medial Patellofemoral Ligament Reconstruction in Children - a 2-8 Years Follow-up Study Active, not recruiting

Radical Surgery for Advanced Gastric- or GEJ-cancer With Oligometastatic Dissmination to the Liver Recruiting

Selective Internal Radiation Therapy With 90Y Resin Micropheres for Refractory Colorectal Cancer Liver Metastases Recruiting

Thyroid Nodule Gene Sequencing in a Danish Population Active, not recruiting

Other trials for the same condition

Open-label, Long-term Safety Study of Secukinumab in Polymyalgia Rheumatica (PMR) Active, not recruiting

Effect of Supplemental Hydrocortisone During Stress in Prednisolone-induced Adrenal Insufficiency Recruiting

DANIsh VASculitis Database (DANIVAS) Recruiting

Improved Diagnostics and Monitoring of Polymyalgia Rheumatica Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05636501 on ClinicalTrials.gov ↗ ← All trials in Denmark