Polymyalgia Rheumatica (PMR)REMAP PMRNCT07010484
Using Novel Imaging to Rethink Diagnostic and Treatment Strategies for Polymyalgia Rheumatica
An observational study of Polymyalgia Rheumatica (PMR), run by Kresten Krarup Keller at 7 sites in Denmark.
Trial summary
Polymyalgia rheumatica (PMR) is the most common chronic inflammatory rheumatic disease among the elderly and is characterized by proximal extremity pain and fatigue. Treatment with prednisolone carries several significant adverse effects, and it is therefore essential to avoid unnecessary treatment. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Polymyalgia Rheumatica (PMR)
- What is being tested?
- PET/MRI and PET/CT with 18-FDG
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 149 participants
- Where
- 7 sitesDenmark
- Study dates
- 21 Aug 2025to 31 Aug 2032
- 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: Patients suspected of and diagnosed with polymyalgia rheumatica are included.
Who may be able to join
- Patients suspected of PMR seen at the Department of Rheumatology/internal medicine in Aarhus, Silkeborg, Horsens, Gødstrup, Randers, and Svendborg.
- Age above 50.
- Proximal extremity pain.
Who cannot join
- Oral, intravenous, intra-articular or intramuscular glucocorticoids within the last 2 months.
- Previous prednisolone treatment for GCA/PMR.
- Unable to give consent.
- Proximal extremity pain duration for more than one year.
- Symptoms of GCA (headache, scalp tenderness, jaw or tongue claudication, vision disturbances attributable to GCA, limb claudication).
- Active malignant cancers within the last 5 years (except basal cell carcinoma).
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- Other known inflammatory rheumatic diseases (e.g. rheumatoid arthritis, polymyositis, spondyloarthritis, psoriatic arthritis, gout).
- Uncontrolled diseases (e.g. severe active asthma, cardiac disease with NYHA class IV)
- For MRI: Implants contraindicating MRI and BMI>150 kg.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Denmark7 sites, 7 recruiting
- Recruiting
Aarhus University Hospital
Aarhus
Kresten K Keller
- Not yet recruiting
Gødstrup Hospital
Gødstrup
- Not yet recruiting
Horsens Regional Hospital
Horsens
- Not yet recruiting
Odense University Hospital
Odense
- Not yet recruiting
Randers Regional Hospital
Randers
- Recruiting
Central Jutland Regional Hospital
Silkeborg
- Not yet recruiting
Svendborg Hospital
Svendborg
About this study
Polymyalgia rheumatica (PMR) is the most common chronic inflammatory rheumatic disease among the elderly and is characterized by proximal extremity pain and fatigue. Treatment with prednisolone carries several significant adverse effects, and it is therefore essential to avoid unnecessary treatment. However, clinical diagnosis and even imaging such as positron emission tomography and computed tomography (PET/CT) has low diagnostic accuracy, which decrease after start of prednisolone. The purpose is to evaluate a new method to diagnose PMR with PET/CT using magnetic resonance imaging (MRI) for informing the interpretation of PET in 111 patients suspected of PMR at baseline and after 8 weeks prednisolone treatment. In addition, a treatment initiation strategy guided by clinical diagnosis combined with PET will be evaluated in 100 patients with newly diagnosed PMR.
- Conditions
- Polymyalgia Rheumatica (PMR)
- Being tested
- PET/MRI, PET/CT with 18-FDG
- Keywords
- polymyalgia rheumatica, imaging, diagnosis, PET/CT, PET/MRI
- Medical subject headings
- Polymyalgia Rheumatica, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/MRIDiagnostic test
PET/MRI at baseline and week 8
PET/CT with 18-FDGDiagnostic test
PET/CT in patients not receiving PET/MRI
| Study group | Role | What they receive |
|---|---|---|
| Patients with and suspected of polymyalgia rheumatica | The study evaluate a new method to diagnose PMR with PET/CT using magnetic resonance imaging (MRI) for informing the interpretation of PET in 111 patients suspected of polymyalgia rheumatica (PMR) at baseline and after 8 weeks prednisolone treatment.
In addition, a treatment initiation strategy guided by clinical diagnosis combined with PET will be evaluated in 100 patients with newly diagnosed PMR (estimated 64 from the 111 patients with suspected PMR, and additionally 38 diagnosed with PMR of which approximately 34 will have PMR without concurrent giant cell arteritis). Patients with a clinical diagnosis of PMR and a negative PET will not be started in routine treatment, but receive intramuscular glucocorticoids, which can be followed by oral prednisolone 15 mg tapered during a maximum of 3 month after diagnosis at discretion of the investigator. Receives: Diagnostic Test: PET/MRI; Diagnostic Test: PET/CT with 18-FDG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical diagnosis of PMR after 1 year and a positive baseline [18F]FDG-PET scan, with MRI findings used to support interpretation of the PET evaluation.
sensitivity and specificity of [18F]FDG-PET/CT using PET combined with MRI to inform the interpretation of the PET evaluation, using the clinical diagnosis at 1 year as reference standard.
Measured: Baseline
A clinical diagnosis of PMR at baseline and a negative PET not requiring glucocorticoids for more than 3 months during the first year.
proportion of patients with a positive clinical diagnosis and a negative PET not requiring glucocorticoids for more than 3 months during the first year.
Measured: Baseline to 1 year
Secondary outcomes (21)
Clinical diagnosis of PMR after 1 year and a positive [18F]FDG-PET/MRI at baseline.
Sensitivity and specificity of [18F]FDG-PET/MRI at baseline for diagnosing PMR, using the clinical diagnosis at 1 year as reference standard.
Measured: Baseline
Clinical diagnosis of PMR after 1 year and a positive MRI at baseline.
Sensitivity and specificity of MRI at baseline for diagnosing PMR, using the clinical diagnosis at 1 year as reference standard.
Measured: Baseline
Circular, focal, and/or cylindrical [18F]FDG-uptake patterns associated to synovitis, bursitis, and tendinitis/tenosynovitis in the shoulders and hips on MRI or ultrasound.
Investigate if circular, focal and cylindrical [18F]FDG-uptake patterns correspond to synovitis, bursitis and tendinitis using MRI and ultrasound for confirmation.
Measured: Baseline
Clinical diagnosis of PMR after 1 year and synovitis, bursitis, and tendinitis/tenosynovits in the shoulders and hips.
Prevalence of synovitis, tendinitis/tenosynovitis and bursitis in PMR and differential diagnoses.
Measured: Baseline
Clinical diagnosis of PMR after 1 year and extra-capsular PMR diagnosed using [18F]FDG-PET/MRI.
Proportion of patients with capsular and extra-capsular PMR.
Measured: Baseline
Extra-capsular PMR and remission after 2 or 4 weeks.
Time to remission in patients with extra-capsular involvement compared to PMR patients with capsular involvement.
Measured: Baseline to 4 weeks
Extra-capsular PMR with relapse and remaining in prednisolone treatment within the first year, first 3 years, and first 5 years.
Proportion of patients with capsular and extra-capsular PMR who experience relapse and remain in prednisolone treatment within the first year, first 3 years, and first 5 years.
Measured: Baseline to 5 years
Clinical diagnosis of PMR after 1 year and a positive [18F]FDG-PET/CT after 8 weeks of prednisolone treatment, with MRI findings used to support PET interpretation.
Sensitivity and specificity of [18F]FDG-PET after 8 weeks of prednisolone treatment using PET combined with MRI to inform the interpretation of PET scans for diagnosing PMR, using the clinical diagnosis at 1 year as reference standard.
Measured: 8 weeks
Clinical diagnosis of PMR after 1 year and a positive [18F]FDG-PET/MRI after 8 weeks of prednisolone treatment.
Sensitivity and specificity of [18F]FDG-PET/MRI after 8 weeks of prednisolone treatment for diagnosing PMR, using the clinical diagnosis at 1 year as reference standard.
Measured: 8 weeks
Clinical diagnosis of PMR after 1 year and a positive MRI after 8 weeks of prednisolone treatment.
Sensitivity and specificity of MRI after 8 weeks of prednisolone treatment for diagnosing PMR, using the clinical diagnosis at 1 year as reference standard.
Measured: 8 weeks
Specific baseline clinical information and baseline, 8 weeks, or changes after 8 weeks of prednisolone treatment on [18F]FDG-PET/MRI findings, and the prediction of relapse and prednisolone-free remission after 1 year, 3 years, and 5 years.
Investigate whether clinical information or [18F]FDG-PET/MRI findings at baseline, 8 weeks, or changes after 8 weeks of prednisolone treatment can predict relapse and prednisolone-free remission after 1 year, 3 years, and 5 years.
Measured: Baseline to 5 years
Specific baseline clinical information and baseline, 8 weeks, or changes after 8 weeks of prednisolone treatment on MRI findings, and the prediction of relapse and prednisolone-free remission after 1 year, 3 years, and 5 years.
Investigate whether clinical information or MRI findings at baseline, 8 weeks, or changes after 8 weeks of prednisolone treatment can predict relapse and prednisolone-free remission after 1 year, 3 years, and 5 years.
Measured: Baseline to 5 years
Specific baseline clinical information and baseline, 8 weeks, or changes after 8 weeks of prednisolone treatment on ultrasonography findings, and the prediction of relapse and prednisolone-free remission after 1 year, 3 years, and 5 years.
Investigate whether clinical information and ultrasonography findings at baseline, 8 weeks, or changes after 8 weeks of prednisolone treatment can predict relapse and prednisolone-free remission after 1 year, 3 years, and 5 years.
Measured: Baseline to 5 years
Baseline characteristics for patients with a positive PET scan and a clinical diagnosis of PMR at baseline.
Compare baseline characteristics between patients with a positive PET scan and a clinical diagnosis of PMR and those with a negative PET scan and a clinical diagnosis of PMR.
Measured: Baseline
Baseline MRI findings for patients with a positive PET scan and a clinical diagnosis of PMR at baseline.
Compare MRI findings between patients with a positive PET scan and a clinical diagnosis of PMR and those with a negative PET scan and a clinical diagnosis of PMR.
Measured: Baseline
Baseline characteristics for patients with a clinical diagnosis of PMR at baseline and a negative PET scan not receiving glucocorticoids for more than 3 months during the first year.
Investigate if baseline characteristics can predict which patients with a clinical PMR diagnosis will have a negative PET and require glucocorticoids for no longer than 3 months during the first year.
Measured: Baseline to 1 year
Clinical diagnosis of PMR after 1 year and symptomatic or asymptomatic (subclinical) GCA at diagnosis, week 8, year 1, year 3, and year 5 in patients diagnosed with PMR.
Prevalence of symptomatic and asymptomatic (subclinical) GCA at diagnosis, week 8, year 1, year 3 and year 5 in patients diagnosed with PMR.
Measured: Baseline to 5 years
Clinical diagnosis of PMR after 1 year and positive ultrasound findings around the shoulders and hips at baseline, week 8, year 1, year 3, and year 5.
Changes in ultrasound findings around the shoulders and hips during 1 year, 3 years and 5 years.
Measured: Baseline to 5 years
Physical activity evaluated with step count using the physical activity tracking application over the course of one year in patients with PMR.
Changes in physical activity during the first year after diagnosis.
Measured: Baseline to 1 year
Decreased physical activity during doctor-diagnosed relapses of PMR.
Investigate if relapses of PMR can be detected with physical activity tracking.
Measured: Baseline to 1 year
Fulfilling the criteria for fibromyalgia at baseline and after 1, 3, and 5 years.
Proportion of PMR patients fulfilling the criteria for fibromyalgia after 1 year, 3 years and 5 years.
Measured: Baseline to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start21 Aug 2025
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polymyalgia Rheumatica (PMR)Studies 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
- 149 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kresten Krarup Keller
- Sponsor type
- University, hospital or other
- Collaborators
- Randers Regional Hospital, Central Jutland Regional Hospital, Gødstrup Hospital, Svendborg Hospital, Odense University Hospital, Regionshospitalet Horsens
- Responsible party
- Sponsor-investigator, Kresten Krarup Keller, Aarhus University Hospital
- Investigators
- Kresten K Keller, MD, PhD, Principal investigator, Department of Rheumatology, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07010484
- Sponsor's protocol ID
- 1-10-72-69-25
- Other IDs
- NNF24OC0094827
- Acronym
- REMAP PMR
- Status last verified
- Sep 2025
- First submitted
- 30 May 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in the publications
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Novel Imaging to Rethink Diagnostic and Treatment Strategies for Polymyalgia Rheumatica
- ClinicalTrials.gov ID
- NCT07010484
- Acronym / sponsor ID
- REMAP PMR / 1-10-72-69-25
- Conditions
- Polymyalgia Rheumatica (PMR)
- Keywords
- polymyalgia rheumatica, imaging, diagnosis, PET/CT, PET/MRI
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 149 participants (estimated)
- Lead sponsor
- Kresten Krarup KellerUniversity, hospital or other
- Collaborators
- Randers Regional Hospital, Central Jutland Regional Hospital, Gødstrup Hospital, Svendborg Hospital, Odense University Hospital, Regionshospitalet Horsens
- Study start
- 21 Aug 2025 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2032 (estimated)
- First posted
- 8 Jun 2025 (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.
Polymyalgia rheumatica (PMR) is the most common chronic inflammatory rheumatic disease among the elderly and is characterized by proximal extremity pain and fatigue. Treatment with prednisolone carries several significant adverse effects, and it is therefore essential to avoid unnecessary treatment. However, clinical diagnosis and even imaging such as positron emission tomography and computed tomography (PET/CT) has low diagnostic accuracy, which decrease after start of prednisolone. The purpose is to evaluate a new method to diagnose PMR with PET/CT using magnetic resonance imaging (MRI) for informing the interpretation of PET in 111 patients suspected of PMR at baseline and after 8 weeks prednisolone treatment. In addition, a treatment initiation strategy guided by clinical diagnosis combined with PET will be evaluated in 100 patients with newly diagnosed PMR.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with and suspected of polymyalgia rheumatica | – | Diagnostic Test: PET/MRI, Diagnostic Test: PET/CT with 18-FDGThe study evaluate a new method to diagnose PMR with PET/CT using magnetic resonance imaging (MRI) for informing the interpretation of PET in 111 patients suspected of polymyalgia rheumatica (PMR) at baseline and after 8 weeks prednisolone treatment. In addition, a treatment initiation strategy guided by clinical diagnosis combined with PET will be evaluated in 100 patients with newly diagnosed PMR (estimated 64 from the 111 patients with suspected PMR, and additionally 38 diagnosed with PMR of which approximately 34 will have PMR without concurrent giant cell arteritis). Patients with a clinical diagnosis of PMR and a negative PET will not be started in routine treatment, but receive intramuscular glucocorticoids, which can be followed by oral prednisolone 15 mg tapered during a maximum of 3 month after diagnosis at discretion of the investigator. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suspected of and diagnosed with polymyalgia rheumatica are included.
Key inclusion criteria (3 listed)
- Patients suspected of PMR seen at the Department of Rheumatology/internal medicine in Aarhus, Silkeborg, Horsens, Gødstrup, Randers, and Svendborg.
- Age above 50.
- Proximal extremity pain.
Key exclusion criteria (9 listed)
- Oral, intravenous, intra-articular or intramuscular glucocorticoids within the last 2 months.
- Previous prednisolone treatment for GCA/PMR.
- Unable to give consent.
- Proximal extremity pain duration for more than one year.
- Symptoms of GCA (headache, scalp tenderness, jaw or tongue claudication, vision disturbances attributable to GCA, limb claudication).
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/MRIPET/MRI at baseline and week 8 | Diagnostic test | Patients with and suspected of polymyalgia rheumatica |
| PET/CT with 18-FDGPET/CT in patients not receiving PET/MRI | Diagnostic test | Patients with and suspected of polymyalgia rheumatica |
Primary outcome
Clinical diagnosis of PMR after 1 year and a positive baseline [18F]FDG-PET scan, with MRI findings used to support interpretation of the PET evaluation.
Time frame: Baseline
sensitivity and specificity of [18F]FDG-PET/CT using PET combined with MRI to inform the interpretation of the PET evaluation, using the clinical diagnosis at 1 year as reference standard.
A clinical diagnosis of PMR at baseline and a negative PET not requiring glucocorticoids for more than 3 months during the first year.
Time frame: Baseline to 1 year
proportion of patients with a positive clinical diagnosis and a negative PET not requiring glucocorticoids for more than 3 months during the first year.
21 secondary outcomes
Clinical diagnosis of PMR after 1 year and a positive [18F]FDG-PET/MRI at baseline.
Time frame: Baseline
Clinical diagnosis of PMR after 1 year and a positive MRI at baseline.
Time frame: Baseline
Circular, focal, and/or cylindrical [18F]FDG-uptake patterns associated to synovitis, bursitis, and tendinitis/tenosynovitis in the shoulders and hips on MRI or ultrasound.
Time frame: Baseline
Clinical diagnosis of PMR after 1 year and synovitis, bursitis, and tendinitis/tenosynovits in the shoulders and hips.
Time frame: Baseline
Clinical diagnosis of PMR after 1 year and extra-capsular PMR diagnosed using [18F]FDG-PET/MRI.
Time frame: Baseline
Extra-capsular PMR and remission after 2 or 4 weeks.
Time frame: Baseline to 4 weeks
Extra-capsular PMR with relapse and remaining in prednisolone treatment within the first year, first 3 years, and first 5 years.
Time frame: Baseline to 5 years
Clinical diagnosis of PMR after 1 year and a positive [18F]FDG-PET/CT after 8 weeks of prednisolone treatment, with MRI findings used to support PET interpretation.
Time frame: 8 weeks
Clinical diagnosis of PMR after 1 year and a positive [18F]FDG-PET/MRI after 8 weeks of prednisolone treatment.
Time frame: 8 weeks
Clinical diagnosis of PMR after 1 year and a positive MRI after 8 weeks of prednisolone treatment.
Time frame: 8 weeks
Specific baseline clinical information and baseline, 8 weeks, or changes after 8 weeks of prednisolone treatment on [18F]FDG-PET/MRI findings, and the prediction of relapse and prednisolone-free remission after 1 year, 3 years, and 5 years.
Time frame: Baseline to 5 years
Specific baseline clinical information and baseline, 8 weeks, or changes after 8 weeks of prednisolone treatment on MRI findings, and the prediction of relapse and prednisolone-free remission after 1 year, 3 years, and 5 years.
Time frame: Baseline to 5 years
Specific baseline clinical information and baseline, 8 weeks, or changes after 8 weeks of prednisolone treatment on ultrasonography findings, and the prediction of relapse and prednisolone-free remission after 1 year, 3 years, and 5 years.
Time frame: Baseline to 5 years
Baseline characteristics for patients with a positive PET scan and a clinical diagnosis of PMR at baseline.
Time frame: Baseline
Baseline MRI findings for patients with a positive PET scan and a clinical diagnosis of PMR at baseline.
Time frame: Baseline
Baseline characteristics for patients with a clinical diagnosis of PMR at baseline and a negative PET scan not receiving glucocorticoids for more than 3 months during the first year.
Time frame: Baseline to 1 year
Clinical diagnosis of PMR after 1 year and symptomatic or asymptomatic (subclinical) GCA at diagnosis, week 8, year 1, year 3, and year 5 in patients diagnosed with PMR.
Time frame: Baseline to 5 years
Clinical diagnosis of PMR after 1 year and positive ultrasound findings around the shoulders and hips at baseline, week 8, year 1, year 3, and year 5.
Time frame: Baseline to 5 years
Physical activity evaluated with step count using the physical activity tracking application over the course of one year in patients with PMR.
Time frame: Baseline to 1 year
Decreased physical activity during doctor-diagnosed relapses of PMR.
Time frame: Baseline to 1 year
Fulfilling the criteria for fibromyalgia at baseline and after 1, 3, and 5 years.
Time frame: Baseline to 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 1 Oct 2025.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in the publications
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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.
Kresten K Keller, MD, PhD principal investigator
Department of Rheumatology, Aarhus University Hospital
7 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 (PMR), run by Kresten Krarup Keller at 7 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: looking for participants now, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
Contact Kresten K Keller, MD, PhD (+45 40384984, krekel@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical diagnosis of PMR after 1 year and a positive baseline [18F]FDG-PET scan, with MRI findings used to support interpretation of the PET evaluation. (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Oct 2025.