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

Launched by AARHUS UNIVERSITY HOSPITAL · Dec 1, 2022

Keywords

ClinConnect Summary

This clinical trial is exploring the best way to reduce the dosage of prednisolone, a medication used to treat Polymyalgia Rheumatica (PMR), a condition that causes pain and stiffness in the muscles and joints. The goal is to see if a structured, nurse-led approach to tapering the medication is more effective than the usual method where general practitioners decide how to adjust the dose. The trial will include 120 patients who are newly diagnosed with PMR and will last for two years, with one year of treatment and another year of follow-up.

To participate, individuals must be over 50 years old, speak and understand Danish well enough to complete questionnaires, and have been diagnosed with PMR according to specific criteria. Those who have received recent treatment with glucocorticoids (a type of steroid medication), have certain symptoms or other serious health conditions, or cannot provide consent will not be eligible. Participants can expect regular check-ins and assessments throughout the trial to monitor their health and how well the treatment is working. This study aims to improve treatment strategies for PMR, ultimately helping patients feel better and experience fewer side effects from medication.

Gender

ALL

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)

Trial Officials