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

NCT05636501 | Active Not Recruiting

• 1 other identifier: T2T PMR
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 6

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• Change in prednisolone dose from baseline to week 52

  52 weeks

• Proportion of GCA patients diagnosed during the first 52 weeks

  52 weeks

• Self-reported number of relapses during the first 52 weeks

  52 weeks

• Change in patient-reported global visual analogue scale (VAS) from baseline to week 52

  52 weeks

• Change in polymyalgia rheumatica activity score (PMR-AS) from baseline to week 52

  52 weeks

Study Arms (2)

Treat-to-target Prednisolone Taper

ACTIVE COMPARATOR

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

Usual Care

PLACEBO COMPARATOR

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

Interventions

Usual care OTHER

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

Usual Care

Treat-to-target Prednisolone Taper OTHER

Systematic prednisolone taper

Treat-to-target Prednisolone Taper

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Regionshospitalet Silkeborg: collaborator
• Regionshospital Nordjylland: collaborator
• Aalborg University Hospital: collaborator
• Frederiksberg University Hospital: collaborator
• Aarhus University Hospital: lead
• Horsens Hospital: collaborator
• Gødstrup Hospital: collaborator

Study Sites (6)

Aalborg University Hospital

Aalborg, Denmark

Location

Aarhus University Hospital, Department of Rheumatology

Aarhus, Denmark

Location

Gødstrup Regional Hospital

Herning, Denmark

Location

Hjørring Regional Hospital

Hjørring, Denmark

Location

Horsens Regional Hospital

Horsens, Denmark

Location

Silkeborg Regional Hospital

Silkeborg, Denmark

Location

MeSH Terms

Conditions

Polymyalgia Rheumatica

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Kresten Keller

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD associate professor

Study Record Dates

• First Submitted: November 10, 2022
• First Posted: December 5, 2022
• Study Start: January 12, 2023
• Primary Completion: October 9, 2025
• Study Completion (Estimated): November 1, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Starting 6 months after publication, and 2 years.
• Access Criteria: By resonably request.

Locations

DK (6)