Treat-to-target Prednisolon Taper in Patients With Polymyalgia Rheumatica
Launched by AARHUS UNIVERSITY HOSPITAL · Dec 1, 2022
Trial Information
Current as of January 14, 2025
Recruiting
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
Kresten Keller
Principal Investigator
Aarhus University Hospital
About Aarhus University Hospital
Aarhus University Hospital is a leading research institution in Denmark, dedicated to advancing medical science and improving patient care through innovative clinical trials. As a key sponsor of clinical research, the hospital integrates cutting-edge technology and multidisciplinary expertise to conduct studies that address critical health challenges. With a commitment to ethical standards and patient safety, Aarhus University Hospital collaborates with a diverse network of academic and industry partners, ensuring that its research initiatives contribute to the global body of medical knowledge and enhance treatment options for patients.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Aalborg, , Denmark
Randers, , Denmark
Horsens, , Denmark
Herning, , Denmark
Silkeborg, , Denmark
Aarhus, , Denmark
Esbjerg, , Denmark
Hjørring, , Denmark
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0
Similar Trials