Early access
Sign in
Active, not recruitingNo phase

Improved Diagnostics and Monitoring of Polymyalgia Rheumatica

Key facts

Who runs it
Kresten Krarup Keller
Where
Denmark3 sites in 1 countryChoose a country to see its sites
Trial code
Status
Active, not recruiting
People taking part
98 people enrolled
Started
14 Sept 2020
Expected to end
30 Jun 2027
Type of study
Observational
Treatments tested
  • PET/CT
Record updated
24 September 2025

Who can take part

Age
50 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 12 criteriaShow less

Who can take part

  • Patients suspected of PMR
  • Age above 50
  • Pain of the proximal muscles

Who cannot take part

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

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The group in the trial

  • Patients with suspected polymyalgia rheumatica

    The study investigates patients with suspected polymyalgia rheumatica (PMR). For Patients where the PMR diagnosis is dismissed, the study terminates after the first visit. Patients diagnosed with PMR will be treated with prednisolone with taper corresponding to usual care. At baseline all patients will have medical history taken, physical examination, blood drawn, Synacthen® test, PET/CT, and ultrasound performed. Physical examination, PET/CT, and ultrasound are repeated after 8 weeks of prednisolone treatment while the patients iare on 10 mg prednisolone as well as after prednisolone taper two weeks later, where Synachten® test is also performed. After 10 weeks prednisolone is restarted at 10 mg and the patient is followed by their general practitioner or at the department of rheumatology, where prednisolone is tapered according to usual care. Patients are invited to a follow up visit after one year.

    Treatment: PET/CT

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Publications
Record updated
24 September 2025