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NCT Number: NCT05636501

Treat-to-target Prednisolon 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.

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Key information

Conditions

Polymyalgia Rheumatica Connective Tissue Diseases Muscular Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aalborg University Hospital, Aalborg, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Treat-to-target Prednisolone Taper

Other

Systematic prednisolone taper

Usual Care

Other

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

Primary outcomes

  1. Proportion of patients in prednisolone free remission 52 weeks from baseline

    Time frame: 52 weeks

    Proportion of patients in prednisolone free remission 52 weeks from baseline

Secondary outcomes

  1. Change in prednisolone dose from baseline to week 52

    Time frame: 52 weeks

    Change in prednisolone dose from baseline to week 52. Key secondary.

  2. Proportion of GCA patients diagnosed during the first 52 weeks

    Time frame: 52 weeks

    Proportion of GCA patients diagnosed during the first 52 weeks. Key secondary

  3. Self-reported number of relapses during the first 52 weeks

    Time frame: 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

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

    Time frame: 52 weeks

    Change in patient-reported global VAS from baseline to week 52. Scale 0-10, 10 is worse. Key secondary

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

    Time frame: 52 weeks

    Change in PMR-AS from baseline to week 52. scale 0-indefinitely. High score is worse. Secondary

  6. 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

    Time frame: 52 weeks

    Proportion of patients with an undiagnosed vasculitis assessed by ultrasound at week 52. Secondary

  7. Changes in short form (SF)-36 mental component summary (MCS) from baseline to week 52

    Time frame: 52 weeks

    Changes in SF-36 MCS from baseline to week 52. Secondary

  8. Changes in short form (SF)-36 physical component summary (PCS) from baseline to week 52

    Time frame: 52 weeks

    Changes in SF-36 PCS from baseline to week 52. Secondary

  9. Changes in health assessment questionnaire disability index (HAQ-DI) from baseline to week 52

    Time frame: 52 weeks

    Changes in HAQ-DI from baseline to week 52. High score is worse. Secondary

  10. Changes in patient reported polymyalgia rheumatica visual analog scale (PMR VAS) from baseline to week 52

    Time frame: 52 weeks

    Changes in patient reported PMR VAS from baseline to week 52. High score is worse. Secondary

  11. Changes in patient reported fatigue visal analog scale (VAS) from baseline to week 52

    Time frame: 52 weeks

    Changes in patient reported fatigue VAS from baseline to week 52. Higher is worse. Secondary

  12. Changes in patient reported stiffness visual analog scale (VAS) from baseline to week 52

    Time frame: 52 weeks

    Changes in patient reported stiffness VAS from baseline to week 52. Higher is worse. Secondary

  13. Changes in patient reported duration of morning stiffness from baseline to week 52

    Time frame: 52 weeks

    Changes in patient reported duration of morning stiffness from baseline to week 52. Secondary

  14. Proportion of patients where baseline DXA scan are performed during the first 3 months after baseline visit

    Time frame: 3 months

    Proportion of patients where baseline DXA scan are performed during the first 3 months after baseline visit. Secondary

  15. Proportion of patients where HgbA1C blood samples are taken during the first 52 weeks

    Time frame: 52 weeks

    Proportion of patients where HgbA1C blood samples are taken during the first 52 weeks. Secondary

  16. Frequency of patient reported adverse effects and comorbidities related to prednisolone treatment after 13, 26, 39 and 52 weeks

    Time frame: 52 weeks

    Frequency of patient reported adverse effects and comorbidities related to prednisolone treatment after 13, 26, 39 and 52 weeks. Secondary.

  17. Proportion of patients with patient reported infections during the first 52 weeks

    Time frame: 52 weeks

    Proportion of patients with patient reported infections during the first 52 weeks. Secondary.

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Collaborators

  • Aalborg University Hospital
  • Frederiksberg University Hospital
  • Gødstrup Hospital
  • Horsens Hospital
  • Regionshospital Nordjylland
  • Regionshospitalet Silkeborg

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Dec 5, 2022
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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