Improved Diagnostics and Monitoring of Polymyalgia Rheumatica

NCT04519580 | Active Not Recruiting

• 1 other identifier: IMPROVE PMR
• Study Type: observational
• Target: 98
• Locations: 1 country
• Sites: 3

Brief 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

Polymyalgia Rheumatica; Giant Cell Arteritis; Adrenal Insufficiency

Keywords

Positron emission computed tomography; Ultrasound

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline

Secondary Outcomes (28)

• PMR diagnosis at week 8 with PET/CT

  8 weeks

• PMR diagnosis at week 10 with PET/CT

  10 weeks

• Change in Ultrasound parameters from baseline to week 8

  8 weeks

• Change in Ultrasound parameters from week 8 to week 10

  10 weeks

• Change in PET/CT parameters from baseline to week

  8 weeks

Study Arms (1)

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

PET/CT DIAGNOSTIC_TEST

FDG-PET/CT at baseline, week 8 and week 10.

Also known as: Ultrasound

Patients with suspected polymyalgia rheumatica

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study will include patients suspected for PMR.

You may qualify if:

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

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Kresten Krarup Keller: lead
• Aarhus University Hospital: collaborator

Study Sites (3)

Department of Rheumatology, Aarhus University Hospital

Aarhus, 8200, Denmark

Location

Department of Rheumatology, Horsens Regional Hospital

Horsens, 8700, Denmark

Location

Diagnostic Centre, Silkeborg Regional Hospital

Silkeborg, 8600, Denmark

Location

Related Publications (4)

• 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). 2025 Nov 20:keaf614. doi: 10.1093/rheumatology/keaf614. Online ahead of print.

  PMID: 41264768 DERIVED

• 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.

  PMID: 40307615 DERIVED

• 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.

  PMID: 39180419 DERIVED

• 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.

  PMID: 38563881 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, plasma, serum

MeSH Terms

Conditions

Polymyalgia Rheumatica; Giant Cell Arteritis; Adrenal Insufficiency

Interventions

Positron Emission Tomography Computed Tomography; Ultrasonography

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Vasculitis, Central Nervous System; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arteritis; Vasculitis; Skin Diseases, Vascular; Skin Diseases; Autoimmune Diseases; Immune System Diseases; Adrenal Gland Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Positron-Emission Tomography; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, X-Ray Computed; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Kresten Keller, MD

  Department of Rheumatology, Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: August 17, 2020
• First Posted: August 19, 2020
• Study Start: September 14, 2020
• Primary Completion: July 4, 2023
• Study Completion (Estimated): June 30, 2027
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (3)