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

NCT05636501 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-12-18

No results posted yet for this 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.

Conditions

  • Polymyalgia Rheumatica

Interventions

OTHER

Treat-to-target Prednisolone Taper

Systematic prednisolone taper

OTHER

Usual care

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

Sponsors & Collaborators

  • Horsens Hospital

    collaborator OTHER

  • Regionshospitalet Silkeborg

    collaborator OTHER

  • Gødstrup Hospital

    collaborator OTHER

  • Regionshospital Nordjylland

    collaborator OTHER_GOV

  • Aalborg University Hospital

    collaborator OTHER

  • Frederiksberg University Hospital

    collaborator OTHER

  • Aarhus University Hospital

    lead OTHER

Principal Investigators

  • Kresten Keller · Aarhus University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-12
Primary Completion
2025-10-09
Completion
2026-11-30

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05636501 on ClinicalTrials.gov