Polymyalgia RheumaticaNCT04519580
Improved Diagnostics and Monitoring of Polymyalgia Rheumatica
An observational study of Polymyalgia Rheumatica and Giant Cell Arteritis, run by Kresten Krarup Keller at 3 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Polymyalgia Rheumatica, Giant Cell Arteritis, Adrenal Insufficiency
- What is being tested?
- PET/CT
- How many people
- 98 participants
- Where
- 3 sitesDenmark
- Study dates
- 14 Sep 2020to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will include patients suspected for PMR.
Who may be able to join
- Patients suspected of PMR.
- Age above 50
- Pain of the proximal muscles.
Who cannot join
- 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).
Show all 9Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Department of Rheumatology, Aarhus University Hospital
Aarhus, 8200
Department of Rheumatology, Horsens Regional Hospital
Horsens, 8700
Diagnostic Centre, Silkeborg Regional Hospital
Silkeborg, 8600
About this study
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.
- Being tested
- PET/CT
- Keywords
- Positron emission computed tomography, Ultrasound
- Medical subject headings
- Polymyalgia Rheumatica, Giant Cell Arteritis, Adrenal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/CTDiagnostic test
Also called Ultrasound
FDG-PET/CT at baseline, week 8 and week 10.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (28)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 10 weeks
Change in PET/CT parameters from baseline to week
Change in PET/CT parameters from baseline to week 8.
Measured: 8 weeks
Change in PET/CT parameters from week 8 to week 10.
Change in PET/CT parameters from week 8 to week 10.
Measured: 10 weeks
Frequency of adrenal insufficiency at week 10.
Frequency of adrenal insufficiency at week 10.
Measured: 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.
Measured: 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.
Measured: 10 weeks
Frequency of adrenal insufficiency
Frequency of adrenal insufficiency after 1 and 1.5 years.
Measured: 18 months
Lean boyd weight
Lean body weight adjusted prednisolone dose as a predictor of adrenal insufficiency.
Measured: 18 months
Hypercortisolism as predictor of adrenal insufficiency.
Clinical and biochemical signs of hypercortisolism as predictor of adrenal insufficiency.
Measured: 18 months
Change in clinical parameters week 8.
Change in clinical parameters from baseline to week 8.
Measured: 8 weeks
Change in clinical parameters week 10.
Change in clinical parameters from week 8 to week 10.
Measured: 10 weeks
Frequency of GCA
Frequency of GCA at diagnosis and during follow up
Measured: 12 months
Change in PROM's from baseline to week 8.
Change in PROM's from baseline to week 8.
Measured: 8 weeks
Change in PROM's from week 8 to week 10.
Change in PROM's from week 8 to week 10.
Measured: 10 weeks
Change in PROM's from baseline to 1 year.
Change in PROM's from baseline to 1 year.
Measured: 12 months
Sensitivity and specificity of CRP for PMR diagnosis at week 10.
Sensitivity and specificity of CRP for PMR diagnosis at week 10.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 5 Years
Percentage of patients receiving prednisolone after 3 and 5 years.
Percentage of patients receiving prednisolone after 3 and 5 years.
Measured: 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 +/-)
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2020
- Study start14 Sep 2020
- Primary completion4 Jul 2023
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Polymyalgia RheumaticaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kresten Krarup Keller
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor-investigator, Kresten Krarup Keller, Central Jutland Regional Hospital
- Investigators
- Kresten Keller, MD, Principal investigator, Department of Rheumatology, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04519580
- Sponsor's protocol ID
- IMPROVE PMR
- Status last verified
- Sep 2025
- First submitted
- 17 Aug 2020
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vaben CS, Nielsen AW, Sandovici M, Kjaer SG, Hansen IT, Blegvad-Nissen J, Nielsen BD, Sorensen CM, Bouwman K, Hauge EM, Keller KK, Brouwer E, van der Geest KSM. Diagnostic accuracy of musculoskeletal ultrasound in suspected polymyalgia rheumatica: a multicentre, cohort study. Lancet Rheumatol. 2026 Oct;8(10):e776-e787. doi: 10.1016/S2665-9913(26)00187-6.
PubMed 42767765Gaster 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 41264768Nielsen 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 40307615Vaben 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 40131424Nielsen 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 39180419Nielsen 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
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Diagnostics and Monitoring of Polymyalgia Rheumatica
- ClinicalTrials.gov ID
- NCT04519580
- Acronym / sponsor ID
- IMPROVE PMR
- Keywords
- Positron emission computed tomography, Ultrasound
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Kresten Krarup KellerUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- 14 Sep 2020 (actual)
- Primary completion
- 4 Jul 2023 (actual)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 19 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with suspected polymyalgia rheumatica | – | Diagnostic Test: PET/CTThe 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include patients suspected for PMR.
Key inclusion criteria (3 listed)
- Patients suspected of PMR.
- Age above 50
- Pain of the proximal muscles.
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET/CTAlso: UltrasoundFDG-PET/CT at baseline, week 8 and week 10. | Diagnostic test | Patients with suspected polymyalgia rheumatica |
Primary outcome
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.
28 secondary outcomes
PMR diagnosis at week 8 with PET/CT
Time frame: 8 weeks
PMR diagnosis at week 10 with PET/CT
Time frame: 10 weeks
Change in Ultrasound parameters from baseline to week 8
Time frame: 8 weeks
Change in Ultrasound parameters from week 8 to week 10
Time frame: 10 weeks
Change in PET/CT parameters from baseline to week
Time frame: 8 weeks
Change in PET/CT parameters from week 8 to week 10.
Time frame: 10 weeks
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.
Time frame: 12 months
Presence of adrenal insufficiency at week 10 as a predictor of relapse at week 10.
Time frame: 10 weeks
Frequency of adrenal insufficiency
Time frame: 18 months
Lean boyd weight
Time frame: 18 months
Hypercortisolism as predictor of adrenal insufficiency.
Time frame: 18 months
Change in clinical parameters week 8.
Time frame: 8 weeks
Change in clinical parameters week 10.
Time frame: 10 weeks
Frequency of GCA
Time frame: 12 months
Change in PROM's from baseline to week 8.
Time frame: 8 weeks
Change in PROM's from week 8 to week 10.
Time frame: 10 weeks
Change in PROM's from baseline to 1 year.
Time frame: 12 months
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.
Time frame: 8 weeks
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.
Time frame: 1 year
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.
Time frame: 5 Years
PET/CT measures at baseline as a predictor of prednisolone treatment after 3 and 5 years.
Time frame: 5 Years
Changes in PET/CT parameters from baseline to week 8 as predictor of prednisolone treatment after 3 and 5 years
Time frame: 5 Years
Adrenal insufficiency as a predictor of prednisolone treatment after 3 and 5 years.
Time frame: 5 Years
Changes in US findings from baseline to week 8 as predictor of prednisolone treatment after 3 and 5 years
Time frame: 5 Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- Derived from this study: PubMed 42767765Vaben CS, Nielsen AW, Sandovici M, Kjaer SG, Hansen IT, Blegvad-Nissen J, Nielsen BD, Sorensen CM, Bouwman K, Hauge EM, Keller KK, Brouwer E, van der Geest KSM. Diagnostic accuracy of musculoskeletal ultrasound in suspected polymyalgia rheumatica: a multicentre, cohort study. Lancet Rheumatol. 2026 Oct;8(10):e776-e787. doi: 10.1016/S2665-9913(26)00187-6.
- Derived from this study: PubMed 41264768Gaster 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.
- Derived from this study: PubMed 40307615Nielsen 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.
- Derived from this study: PubMed 40131424Vaben 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.
- Derived from this study: PubMed 39180419Nielsen 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.
- Derived from this study: PubMed 38563881Nielsen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kresten Keller, MD principal investigator
Department of Rheumatology, Aarhus University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polymyalgia Rheumatica and Giant Cell Arteritis, run by Kresten Krarup Keller at 3 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PMR diagnosis at baseline with PET/CT (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04519580, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.