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

Dose Reduction and Discontinuation of Prednisolone Using Structured Treat-to-target Taper in Patients With Polymyalgia Rheumatica

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Polymyalgia Rheumatica
• Intervention / Treatment: Other: Treat-to-target Prednisolone Taper; Other: Usual care

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aalborg, Denmark
    • Aalborg University Hospital
  • Aarhus, Denmark
    • Aarhus University Hospital, Department of Rheumatology
  • Herning, Denmark
    • Gødstrup Regional Hospital
  • Hjørring, Denmark
    • Hjørring Regional Hospital
  • Horsens, Denmark
    • Horsens Regional Hospital
  • Silkeborg, Denmark
    • Silkeborg Regional Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Treat-to-target Prednisolone Taper; 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.	Other: Treat-to-target Prednisolone Taper; Systematic prednisolone taper
Placebo Comparator: Usual Care; 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.	Other: Usual care; Prednisolone taper performed by discretion of the patient's general practitioner.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients in prednisolone free remission 52 weeks from baseline	Proportion of patients in prednisolone free remission 52 weeks from baseline	52 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in prednisolone dose from baseline to week 52	Change in prednisolone dose from baseline to week 52. Key secondary.	52 weeks
Proportion of GCA patients diagnosed during the first 52 weeks	Proportion of GCA patients diagnosed during the first 52 weeks. Key secondary	52 weeks
Self-reported number of relapses during the first 52 weeks	Self-reported number of relapses during the first 52 weeks (assessed by increase in symptoms and an increase in prednisolone dosage). Key secondary	52 weeks
Change in patient-reported global visual analogue scale (VAS) from baseline to week 52	Change in patient-reported global VAS from baseline to week 52. Scale 0-10, 10 is worse. Key secondary	52 weeks
Change in polymyalgia rheumatica activity score (PMR-AS) from baseline to week 52	Change in PMR-AS from baseline to week 52. scale 0-indefinitely. High score is worse. Secondary	52 weeks
Proportion of patients with an undiagnosed vasculitis assessed by ultrasound at week 52 Proportion of patients with an undiagnosed vasculitis assessed by ultrasound at week 52	Proportion of patients with an undiagnosed vasculitis assessed by ultrasound at week 52. Secondary	52 weeks
Changes in short form (SF)-36 mental component summary (MCS) from baseline to week 52	Changes in SF-36 MCS from baseline to week 52. Secondary	52 weeks
Changes in short form (SF)-36 physical component summary (PCS) from baseline to week 52	Changes in SF-36 PCS from baseline to week 52. Secondary	52 weeks
Changes in health assessment questionnaire disability index (HAQ-DI) from baseline to week 52	Changes in HAQ-DI from baseline to week 52. High score is worse. Secondary	52 weeks
Changes in patient reported polymyalgia rheumatica visual analog scale (PMR VAS) from baseline to week 52	Changes in patient reported PMR VAS from baseline to week 52. High score is worse. Secondary	52 weeks
Changes in patient reported fatigue visal analog scale (VAS) from baseline to week 52	Changes in patient reported fatigue VAS from baseline to week 52. Higher is worse. Secondary	52 weeks
Changes in patient reported stiffness visual analog scale (VAS) from baseline to week 52	Changes in patient reported stiffness VAS from baseline to week 52. Higher is worse. Secondary	52 weeks
Changes in patient reported duration of morning stiffness from baseline to week 52	Changes in patient reported duration of morning stiffness from baseline to week 52. Secondary	52 weeks
Proportion of patients where baseline DXA scan are performed during the first 3 months after baseline visit	Proportion of patients where baseline DXA scan are performed during the first 3 months after baseline visit. Secondary	3 months
Proportion of patients where HgbA1C blood samples are taken during the first 52 weeks	Proportion of patients where HgbA1C blood samples are taken during the first 52 weeks. Secondary	52 weeks
Frequency of patient reported adverse effects and comorbidities related to prednisolone treatment after 13, 26, 39 and 52 weeks	Frequency of patient reported adverse effects and comorbidities related to prednisolone treatment after 13, 26, 39 and 52 weeks. Secondary.	52 weeks
Proportion of patients with patient reported infections during the first 52 weeks	Proportion of patients with patient reported infections during the first 52 weeks. Secondary.	52 weeks

Collaborators and Investigators

• Sponsor: Aarhus University Hospital
• Collaborators: Frederiksberg University Hospital; Aalborg University Hospital; Gødstrup Hospital; Horsens Hospital; Regionshospitalet Silkeborg; Regionshospital Nordjylland
• Investigators: Principal Investigator: Kresten Keller, Aarhus University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2023
• Primary Completion (Actual): October 9, 2025
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: November 10, 2022
• First Submitted That Met QC Criteria: December 1, 2022
• First Posted (Actual): December 5, 2022

Study Record Updates

• Last Update Posted (Actual): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 12, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Muscular Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Polymyalgia Rheumatica; Antineoplastic Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Prednisolone
• Other Study ID Numbers: T2T PMR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD that underlie results in the publications
• IPD Sharing Time Frame: Starting 6 months after publication, and 2 years.
• IPD Sharing Access Criteria: By resonably request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No