Improved Diagnostics and Monitoring of Polymyalgia Rheumatica

  • STATUS
    Recruiting
  • End date
    Oct 1, 2023
  • participants needed
    143
  • sponsor
    Kresten Krarup Keller
Updated on 17 February 2021
prednisolone
general symptoms
positron emission tomography/computed tomography
polymyalgia

Summary

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.

Details
Condition Adrenal Insufficiency, Giant Cell Arteritis, Polymyalgia Rheumatica, Polymyalgia Rheumatica (PMR), temporal arteritis, hypoadrenalism, adrenal cortical insufficiency
Treatment PET/CT
Clinical Study IdentifierNCT04519580
SponsorKresten Krarup Keller
Last Modified on17 February 2021

Eligibility

Yes No Not Sure

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
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