Using Novel Imaging to Rethink Diagnostic and Treatment Strategies for Polymyalgia Rheumatica (REMAP PMR)

September 26, 2025 updated by: Kresten Krarup Keller
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
149

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Kresten K Keller, MD, PhD
  • Phone Number: +45 40384984
  • Email: krekel@rm.dk

Study Locations

  • Denmark
      • Aarhus, Denmark
        • Recruiting
        • Aarhus University Hospital
        • Contact:
          • Kresten K Keller
      • Gødstrup, Denmark
        • Not yet recruiting
        • Gødstrup Hospital
      • Horsens, Denmark
        • Not yet recruiting
        • Horsens Regional Hospital
      • Odense, Denmark
        • Not yet recruiting
        • Odense University Hospital
      • Randers, Denmark
        • Not yet recruiting
        • Randers Regional Hospital
      • Silkeborg, Denmark
        • Recruiting
        • Central Jutland Regional Hospital
      • Svendborg, Denmark
        • Not yet recruiting
        • Svendborg Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients suspected of and diagnosed with polymyalgia rheumatica are included.

Description

Inclusion Criteria:

  1. Patients suspected of PMR seen at the Department of Rheumatology/internal medicine in Aarhus, Silkeborg, Horsens, Gødstrup, Randers, and Svendborg.
  2. Age above 50.
  3. Proximal extremity pain.

Exclusion Criteria:

  1. Oral, intravenous, intra-articular or intramuscular glucocorticoids within the last 2 months.
  2. Previous prednisolone treatment for GCA/PMR.
  3. Unable to give consent.
  4. Proximal extremity pain duration for more than one year.
  5. Symptoms of GCA (headache, scalp tenderness, jaw or tongue claudication, vision disturbances attributable to GCA, limb claudication).
  6. Active malignant cancers within the last 5 years (except basal cell carcinoma).
  7. Other known inflammatory rheumatic diseases (e.g. rheumatoid arthritis, polymyositis, spondyloarthritis, psoriatic arthritis, gout).
  8. Uncontrolled diseases (e.g. severe active asthma, cardiac disease with NYHA class IV)
  9. For MRI: Implants contraindicating MRI and BMI>150 kg.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Diagnostic test: PET/MRI
PET/MRI at baseline and week 8
Diagnostic test: PET/CT with 18-FDG
PET/CT in patients not receiving PET/MRI

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline
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.
Baseline to 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clinical diagnosis of PMR after 1 year and a positive [18F]FDG-PET/MRI at baseline.
Time Frame: Baseline
Sensitivity and specificity of [18F]FDG-PET/MRI at baseline for diagnosing PMR, using the clinical diagnosis at 1 year as reference standard.
Baseline
Clinical diagnosis of PMR after 1 year and a positive MRI at baseline.
Time Frame: Baseline
Sensitivity and specificity of MRI at baseline for diagnosing PMR, using the clinical diagnosis at 1 year as reference standard.
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
Investigate if circular, focal and cylindrical [18F]FDG-uptake patterns correspond to synovitis, bursitis and tendinitis using MRI and ultrasound for confirmation.
Baseline
Clinical diagnosis of PMR after 1 year and synovitis, bursitis, and tendinitis/tenosynovits in the shoulders and hips.
Time Frame: Baseline
Prevalence of synovitis, tendinitis/tenosynovitis and bursitis in PMR and differential diagnoses.
Baseline
Clinical diagnosis of PMR after 1 year and extra-capsular PMR diagnosed using [18F]FDG-PET/MRI.
Time Frame: Baseline
Proportion of patients with capsular and extra-capsular PMR.
Baseline
Extra-capsular PMR and remission after 2 or 4 weeks.
Time Frame: Baseline to 4 weeks
Time to remission in patients with extra-capsular involvement compared to PMR patients with capsular involvement.
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
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.
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
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.
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
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.
8 weeks
Clinical diagnosis of PMR after 1 year and a positive MRI after 8 weeks of prednisolone treatment.
Time Frame: 8 weeks
Sensitivity and specificity of MRI after 8 weeks of prednisolone treatment for diagnosing PMR, using the clinical diagnosis at 1 year as reference standard.
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
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.
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
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.
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
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.
Baseline to 5 years
Baseline characteristics for patients with a positive PET scan and a clinical diagnosis of PMR at baseline.
Time Frame: 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.
Baseline
Baseline MRI findings for patients with a positive PET scan and a clinical diagnosis of PMR at baseline.
Time Frame: 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.
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
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.
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
Prevalence of symptomatic and asymptomatic (subclinical) GCA at diagnosis, week 8, year 1, year 3 and year 5 in patients diagnosed with PMR.
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
Changes in ultrasound findings around the shoulders and hips during 1 year, 3 years and 5 years.
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
Changes in physical activity during the first year after diagnosis.
Baseline to 1 year
Decreased physical activity during doctor-diagnosed relapses of PMR.
Time Frame: Baseline to 1 year
Investigate if relapses of PMR can be detected with physical activity tracking.
Baseline to 1 year
Fulfilling the criteria for fibromyalgia at baseline and after 1, 3, and 5 years.
Time Frame: Baseline to 5 years
Proportion of PMR patients fulfilling the criteria for fibromyalgia after 1 year, 3 years and 5 years.
Baseline to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kresten Krarup Keller

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Odense University Hospital
Gødstrup Hospital
Svendborg Hospital
Regionshospitalet Horsens
Randers Regional Hospital
Central Jutland Regional Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kresten K Keller, MD, PhD, Department of Rheumatology, Aarhus University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 21, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2032

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 30, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 8, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 1, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 26, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1-10-72-69-25
  • NNF24OC0094827 (Other Grant/Funding Number: Novo Nordisk Foundation)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD that underlie results in the publications

IPD Sharing Time Frame

Starting 6 months after publication, and 2 years.

IPD Sharing Access Criteria

By resonably request.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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