Active, not recruitingNCT04519580Updated Sep 24, 2025

Improved Diagnostics and Monitoring of Polymyalgia Rheumatica

An observational study in Polymyalgia Rheumatica, Giant Cell Arteritis and Adrenal Insufficiency, sponsored by Kresten Krarup Keller. Active, not recruiting at 3 sites in Denmark. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2025-09-24.

Sponsored by Kresten Krarup Keller · Observational

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 98
Ages: 50 Years and older
Sex: All

Study 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.

Conditions studied

Polymyalgia Rheumatica
Giant Cell Arteritis
Adrenal Insufficiency

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Keywords

Positron emission computed tomography
Ultrasound

In context

Polymyalgia Rheumatica

68 studies on the registry are indexed under Polymyalgia Rheumatica; 22 are open to participants now.

This study's enrollment of 98 is below the median of 133 across 27 observational studies indexed under Polymyalgia Rheumatica.

Browse Polymyalgia Rheumatica studies →

Lead sponsor

Kresten Krarup Keller is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 50 Years and older
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Probability sample

Study population

The study will include patients suspected for PMR.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

Peroral, intraarticular, intramuscular and dermal application of 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 class IV)
Treatment with peroral oestrogens, aminogluthethimid, trilostan, ketoconazole, fluconazol, etomidate, phenobarbital, phenytoin, rifampicin, metyrapon, mitotane.
Known primary or secondary adrenal insufficiency.

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I: No limits: ordinary activity causes no undue tiredness or breathlessness.
II: Slight limits: comfortable at rest, ordinary activity causes symptoms.
III: Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV: Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Study design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 98 participants (actual)
Patient registry: No
Biospecimen retention: Samples with dna

Groups and cohorts

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.
Diagnostic Test: PET/CT

Interventions

Diagnostic testPET/CT
FDG-PET/CT at baseline, week 8 and week 10.
Also known as: Ultrasound

What researchers measure

Primary outcomes

PMR diagnosis at baseline with PET/CT
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.
Time frame: Baseline

Secondary outcomes

PMR diagnosis at week 8 with PET/CT
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.
Time frame: 8 weeks
PMR diagnosis at week 10 with PET/CT
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.
Time frame: 10 weeks
Change in Ultrasound parameters from baseline to week 8
Change in presence and thickness of subdeltoid bursitis and biceps tenosynovitis from baseline to week 8.
Time frame: 8 weeks
Change in Ultrasound parameters from week 8 to week 10
Change in presence and thickness of subdeltoid bursitis and biceps tenosynovitis from week 8 to week 10.
Time frame: 10 weeks
Change in PET/CT parameters from baseline to week
Change in PET/CT parameters from baseline to week 8.
Time frame: 8 weeks
Change in PET/CT parameters from week 8 to week 10.
Change in PET/CT parameters from week 8 to week 10.
Time frame: 10 weeks
Frequency of adrenal insufficiency at week 10.
Frequency of adrenal insufficiency at week 10.
Time frame: 10 weeks
Presence of adrenal insufficiency at week 10 as a predictor of prednisolone cessation at one year.
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 relapse at week 10.
Presence of adrenal insufficiency at week 10 as a predictor of relapse at week 10.
Time frame: 10 weeks
Frequency of adrenal insufficiency
Frequency of adrenal insufficiency after 1 and 1.5 years.
Time frame: 18 months
Lean boyd weight
Lean body weight adjusted prednisolone dose as a predictor of adrenal insufficiency.
Time frame: 18 months
Hypercortisolism as predictor of adrenal insufficiency.
Clinical and biochemical signs of hypercortisolism as predictor of adrenal insufficiency.
Time frame: 18 months
Change in clinical parameters week 8.
Change in clinical parameters from baseline to week 8.
Time frame: 8 weeks
Change in clinical parameters week 10.
Change in clinical parameters from week 8 to week 10.
Time frame: 10 weeks
Frequency of GCA
Frequency of GCA at diagnosis and during follow up
Time frame: 12 months
Change in PROM's from baseline to week 8.
Change in PROM's from baseline to week 8.
Time frame: 8 weeks
Change in PROM's from week 8 to week 10.
Change in PROM's from week 8 to week 10.
Time frame: 10 weeks
Change in PROM's from baseline to 1 year.
Change in PROM's from baseline to 1 year.
Time frame: 12 months
Sensitivity and specificity of CRP for PMR diagnosis at week 10.
Sensitivity and specificity of CRP for PMR diagnosis at week 10.
Time frame: 10 weeks
Level of inflammatory markers in PMR patients at baseline vs. week 8.
Level of inflammatory markers in PMR patients at baseline vs. week 8.
Time frame: 8 weeks
Level of inflammatory markers in PMR patients vs. non PMR patients at baseline.
Level of inflammatory markers in PMR patients vs. non PMR patients at baseline.
Time frame: Baseline
Change in expression levels of clock gene mRNA as marker of prednisolone-induced changes in sleep, lipid levels and glycated hemoglobin.
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
Percentage of patients with concomitant GCA and PMR after 3 and 5 years.
Percentage of patients with concomitant GCA and PMR after 3 and 5 years.
Time frame: 5 Years
Percentage of patients receiving prednisolone after 3 and 5 years.
Percentage of patients receiving prednisolone after 3 and 5 years.
Time frame: 5 Years
PET/CT measures at baseline as a predictor of prednisolone treatment after 3 and 5 years.
PET/CT measures at baseline is measured with Standard Uptake Value and dichrotone evaluation for PMR (PMR +/-)
Time frame: 5 Years
Changes in PET/CT parameters from baseline to week 8 as predictor of prednisolone treatment after 3 and 5 years
PET/CT changes from baseline to 8 weeks in Standard Uptake Value and dichrotone evaluation for PMR (PMR +/-) will be evaluated.
Time frame: 5 Years
Adrenal insufficiency as a predictor of prednisolone treatment after 3 and 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.
Time frame: 5 Years
Changes in US findings from baseline to week 8 as predictor of prednisolone treatment after 3 and 5 years
Ultrasound dichrotone changes from baseline to week 8 will be evaluated (positive/negative for bursitis/artritis)
Time frame: 5 Years

Study locations

3 sites

Department of Rheumatology, Aarhus University Hospital
Aarhus, 8200, Denmark
320 other open studies at this site →
Department of Rheumatology, Horsens Regional Hospital
Horsens, 8700, Denmark
Diagnostic Centre, Silkeborg Regional Hospital
Silkeborg, 8600, Denmark

References and documents

Publications

Gaster T, Nielsen AW, Hansen SB, Donskov AO, Nielsen MK, Hansen IT, Nielsen BD, Kjaer SG, Blegvad-Nissen J, Moller Sorensen C, Hauge EM, Jorgensen JOL, Keller KK. Repeated short corticotropin testing in patients with polymyalgia rheumatica. Rheumatology (Oxford). 2026 Feb 4;65(2):keaf614. doi: 10.1093/rheumatology/keaf614. PubMed 41264768 ↗
Nielsen AW, van Praagh GD, van der Geest KSM, Hansen IT, Nielsen BD, Kjaer SG, Blegvad-Nissen J, Rewers K, Sorensen CM, Brouwer E, Hauge EM, Gormsen LC, Slart RHJA, Keller KK. Whole-body and site specific [18F]FDG uptake patterns on PET/CT have limited value in differentiating between polymyalgia rheumatica and other inflammatory diseases: two cohorts of treatment-naive suspected polymyalgia rheumatica. EJNMMI Res. 2025 Apr 30;15(1):51. doi: 10.1186/s13550-025-01233-7. PubMed 40307615 ↗
Vaben CS, Nielsen AW, Nielsen MK, Moll LT, Mork C, Dalgaard EB, Rasmussen TK, Ostgard RD, Hansen IT, Nielsen BD, Sorensen CM, Blegvad-Nissen J, Kjaer SG, Hauge EM, Keller KK. The effect of prednisolone initiation and short-term discontinuation on the clinical assessment of polymyalgia rheumatica. Rheumatology (Oxford). 2025 Aug 1;64(8):4756-4760. doi: 10.1093/rheumatology/keaf170. PubMed 40131424 ↗
Nielsen AW, Hauge EM, Hansen IT, Nielsen BD, Kjaer SG, Blegvad J, Rewers K, Moller Sorensen C, Gormsen LC, Keller KK. Low incidence of late-onset giant cell arteritis during the first year in patients with polymyalgia rheumatica-a repeated imaging study. Rheumatology (Oxford). 2025 Apr 1;64(4):2193-2198. doi: 10.1093/rheumatology/keae463. PubMed 39180419 ↗
Nielsen AW, Hansen IT, Nielsen BD, Kjaer SG, Blegvad-Nissen J, Rewers K, Sorensen CM, Hauge EM, Gormsen LC, Keller KK. The effect of prednisolone and a short-term prednisolone discontinuation for the diagnostic accuracy of FDG-PET/CT in polymyalgia rheumatica-a prospective study of 101 patients. Eur J Nucl Med Mol Imaging. 2024 Jul;51(9):2614-2624. doi: 10.1007/s00259-024-06697-8. Epub 2024 Apr 2. PubMed 38563881 ↗

Individual participant data

Plan to share: No

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2020 to primary completion in Jul 2023, 33 months.

How these figures are worked out, and which studies are left out of them.

Registered: Aug 17, 2020
First posted: Aug 19, 2020
StartActual: Sep 14, 2020
Primary completionActual: Jul 4, 2023
CompletionEst.: Jun 30, 2027
Last update: Sep 24, 2025

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Sep 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04519580
Lead sponsor: Kresten Krarup Keller
Collaborators: Aarhus University Hospital
Responsible party: Kresten Krarup Keller (MD, PhD, Central Jutland Regional Hospital) — Sponsor-investigator
First posted: Aug 19, 2020
Start date: Sep 14, 2020
Primary completion: Jul 4, 2023
Completion: Jun 30, 2027 (estimated)
Last update: Sep 24, 2025

Study contacts

Kresten Keller, MD

principal investigator · Department of Rheumatology, Aarhus University Hospital

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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