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Active, Not Recruiting

NCT Number: NCT04519580

Improved Diagnostics and Monitoring of Polymyalgia Rheumatica

Background: Polymyalgia rheumatica (PMR) is characterised by pain of the proximal muscles, general symptoms, and raised inflammatory markers. Treatment with prednisolone has several adverse effects. PMR is an exclusion diagnosis, and methods to diagnose and monitor the disease are lacking.

Objective: To investigate if ultrasound and PET/CT can be used to diagnose and monitor PMR. In addition, the importance of prednisolone induced adrenal insufficiency is investigated.

Methods: It is a prospective observational study in patients suspected of PMR. Patients diagnosed with PMR continue in the study. Ultrasound and PET/CT are performed at baseline, after 8 weeks on prednisolone, and after 10 weeks during a short prednisolone break. Adrenal insufficiency is investigated five times throughout the study. After one year the PMR diagnosis is confirmed.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Polymyalgia Rheumatica Adrenal Gland Diseases Adrenal Insufficiency Arteritis Autoimmune Diseases Autoimmune Diseases of the Nervous System Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Connective Tissue Diseases Endocrine System Diseases Giant Cell Arteritis Immune System Diseases Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Rheumatic Diseases Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Vascular Diseases Vasculitis Vasculitis, Central Nervous System

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Rheumatology, Aarhus University Hospital, Aarhus, 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 suspected of PMR.
  • Age above 50
  • Pain of the proximal muscles.

Exclusion criteria

  • Peroral, intraarticular, intramuscular and dermal application of glucocorticoids within the last 3 month.
  • Previous prednisolone treatment for GCA/PMR
  • Unable to give consent.
  • Symptoms of GCA (headache, 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 astma, cardiac disease with NYHA class IV)
  • Treatment with peroral oestrogens, aminogluthethimid, trilostan, ketoconazole, fluconazol, etomidate, phenobarbital, phenytoin, rifampicin, metyrapon, mitotane.
  • Known primary or secondary adrenal insufficiency.

Treatment and study plan

PET/CT

Diagnostic Test

FDG-PET/CT at baseline, week 8 and week 10.

Other names: Ultrasound

Primary outcomes

  1. PMR diagnosis at baseline with PET/CT

    Time frame: Baseline

    Sensitivity and specificity of PET/CT for PMR diagnosis at baseline with the clinical diagnosis after 1 year as reference standard and patients not diagnosed with PMR serving as controls.

Secondary outcomes

  1. PMR diagnosis at week 8 with PET/CT

    Time frame: 8 weeks

    Sensitivity and specificity of PET/CT for PMR diagnosis at week 8 with the clinical diagnosis after 1 year as reference standard and patients not diagnosed with PMR serving as controls.

  2. PMR diagnosis at week 10 with PET/CT

    Time frame: 10 weeks

    Sensitivity and specificity of PET/CT for PMR diagnosis after one week of discontinuation of glucocorticoids (week 10) with the clinical diagnosis after 1 year as reference standard and patients not diagnosed with PMR serving as controls.

  3. Change in Ultrasound parameters from baseline to week 8

    Time frame: 8 weeks

    Change in presence and thickness of subdeltoid bursitis and biceps tenosynovitis from baseline to week 8.

  4. Change in Ultrasound parameters from week 8 to week 10

    Time frame: 10 weeks

    Change in presence and thickness of subdeltoid bursitis and biceps tenosynovitis from week 8 to week 10.

  5. Change in PET/CT parameters from baseline to week

    Time frame: 8 weeks

    Change in PET/CT parameters from baseline to week 8.

  6. Change in PET/CT parameters from week 8 to week 10.

    Time frame: 10 weeks

    Change in PET/CT parameters from week 8 to week 10.

  7. Frequency of adrenal insufficiency at week 10.

    Time frame: 10 weeks

    Frequency of adrenal insufficiency at week 10.

  8. Presence of adrenal insufficiency at week 10 as a predictor of prednisolone cessation at one year.

    Time frame: 12 months

    Presence of adrenal insufficiency at week 10 as a predictor of prednisolone cessation at one year.

  9. Presence of adrenal insufficiency at week 10 as a predictor of relapse at week 10.

    Time frame: 10 weeks

    Presence of adrenal insufficiency at week 10 as a predictor of relapse at week 10.

  10. Frequency of adrenal insufficiency

    Time frame: 18 months

    Frequency of adrenal insufficiency after 1 and 1.5 years.

  11. Lean boyd weight

    Time frame: 18 months

    Lean body weight adjusted prednisolone dose as a predictor of adrenal insufficiency.

  12. Hypercortisolism as predictor of adrenal insufficiency.

    Time frame: 18 months

    Clinical and biochemical signs of hypercortisolism as predictor of adrenal insufficiency.

  13. Change in clinical parameters week 8.

    Time frame: 8 weeks

    Change in clinical parameters from baseline to week 8.

  14. Change in clinical parameters week 10.

    Time frame: 10 weeks

    Change in clinical parameters from week 8 to week 10.

  15. Frequency of GCA

    Time frame: 12 months

    Frequency of GCA at diagnosis and during follow up

  16. Change in PROM's from baseline to week 8.

    Time frame: 8 weeks

    Change in PROM's from baseline to week 8.

  17. Change in PROM's from week 8 to week 10.

    Time frame: 10 weeks

    Change in PROM's from week 8 to week 10.

  18. Change in PROM's from baseline to 1 year.

    Time frame: 12 months

    Change in PROM's from baseline to 1 year.

  19. Sensitivity and specificity of CRP for PMR diagnosis at week 10.

    Time frame: 10 weeks

    Sensitivity and specificity of CRP for PMR diagnosis at week 10.

  20. Level of inflammatory markers in PMR patients at baseline vs. week 8.

    Time frame: 8 weeks

    Level of inflammatory markers in PMR patients at baseline vs. week 8.

  21. Level of inflammatory markers in PMR patients vs. non PMR patients at baseline.

    Time frame: Baseline

    Level of inflammatory markers in PMR patients vs. non PMR patients at baseline.

  22. Change in expression levels of clock gene mRNA as marker of prednisolone-induced changes in sleep, lipid levels and glycated hemoglobin.

    Time frame: 1 year

    Change in expression levels of clock gene mRNA as marker of prednisolone-induced changes in sleep, lipid levels and glycated hemoglobin.

  23. Percentage of patients with concomitant GCA and PMR after 3 and 5 years.

    Time frame: 5 Years

    Percentage of patients with concomitant GCA and PMR after 3 and 5 years.

  24. Percentage of patients receiving prednisolone after 3 and 5 years.

    Time frame: 5 Years

    Percentage of patients receiving prednisolone after 3 and 5 years.

  25. PET/CT measures at baseline as a predictor of prednisolone treatment after 3 and 5 years.

    Time frame: 5 Years

    PET/CT measures at baseline is measured with Standard Uptake Value and dichrotone evaluation for PMR (PMR +/-)

  26. Changes in PET/CT parameters from baseline to week 8 as predictor of prednisolone treatment after 3 and 5 years

    Time frame: 5 Years

    PET/CT changes from baseline to 8 weeks in Standard Uptake Value and dichrotone evaluation for PMR (PMR +/-) will be evaluated.

  27. Adrenal insufficiency as a predictor of prednisolone treatment after 3 and 5 years.

    Time frame: 5 Years

    Adrenal insufficiency (+/-) will be evaluated with synachten test 4-5 times during the first 1,5 year of the study. At least one positive value will contribute to the parameter.

  28. Changes in US findings from baseline to week 8 as predictor of prednisolone treatment after 3 and 5 years

    Time frame: 5 Years

    Ultrasound dichrotone changes from baseline to week 8 will be evaluated (positive/negative for bursitis/artritis)

Sponsors and collaborators

Lead sponsor

Kresten Krarup Keller

Other

Collaborators

  • Aarhus University Hospital

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2027
First posted
Aug 19, 2020
Registry last updated
Sep 24, 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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