Clinical trial NCT04519580: Improved Diagnostics and Monitoring of Polymyalgia Rheumatica
Official title: Improved Diagnostics and Monitoring of Polymyalgia Rheumatica
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Polymyalgia Rheumatica
Giant Cell Arteritis
Adrenal Insufficiency
Keywords: Positron emission computed tomography
Ultrasound
Lead sponsor: Central Jutland Regional Hospital
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2020-08-19
Enrollment: 98
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study will include patients suspected for PMR.

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: PMR diagnosis at baseline with PET/CT
timeFrame: Baseline
Secondary outcomes:
measure: PMR diagnosis at week 8 with PET/CT
timeFrame: 8 weeks
measure: PMR diagnosis at week 10 with PET/CT
timeFrame: 10 weeks
measure: Change in Ultrasound parameters from baseline to week 8
timeFrame: 8 weeks
measure: Change in Ultrasound parameters from week 8 to week 10
timeFrame: 10 weeks
measure: Change in PET/CT parameters from baseline to week
timeFrame: 8 weeks
measure: Change in PET/CT parameters from week 8 to week 10.
timeFrame: 10 weeks
measure: Frequency of adrenal insufficiency at week 10.
timeFrame: 10 weeks
measure: Presence of adrenal insufficiency at week 10 as a predictor of prednisolone cessation at one year.
timeFrame: 12 months
measure: Presence of adrenal insufficiency at week 10 as a predictor of relapse at week 10.
timeFrame: 10 weeks
measure: Frequency of adrenal insufficiency
timeFrame: 18 months
measure: Lean boyd weight
timeFrame: 18 months
measure: Hypercortisolism as predictor of adrenal insufficiency.
timeFrame: 18 months
measure: Change in clinical parameters week 8.
timeFrame: 8 weeks
measure: Change in clinical parameters week 10.
timeFrame: 10 weeks
measure: Frequency of GCA
timeFrame: 12 months
measure: Change in PROM's from baseline to week 8.
timeFrame: 8 weeks
measure: Change in PROM's from week 8 to week 10.
timeFrame: 10 weeks
measure: Change in PROM's from baseline to 1 year.
timeFrame: 12 months
measure: Sensitivity and specificity of CRP for PMR diagnosis at week 10.
timeFrame: 10 weeks
measure: Level of inflammatory markers in PMR patients at baseline vs. week 8.
timeFrame: 8 weeks
measure: Level of inflammatory markers in PMR patients vs. non PMR patients at baseline.
timeFrame: Baseline
measure: Change in expression levels of clock gene mRNA as marker of prednisolone-induced changes in sleep, lipid levels and glycated hemoglobin.
timeFrame: 1 year
measure: Percentage of patients with concomitant GCA and PMR after 3 and 5 years.
timeFrame: 5 Years
measure: Percentage of patients receiving prednisolone after 3 and 5 years.
timeFrame: 5 Years
measure: PET/CT measures at baseline as a predictor of prednisolone treatment after 3 and 5 years.
timeFrame: 5 Years
measure: Changes in PET/CT parameters from baseline to week 8 as predictor of prednisolone treatment after 3 and 5 years
timeFrame: 5 Years
measure: Adrenal insufficiency as a predictor of prednisolone treatment after 3 and 5 years.
timeFrame: 5 Years
measure: Changes in US findings from baseline to week 8 as predictor of prednisolone treatment after 3 and 5 years
timeFrame: 5 Years
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Rheumatology, Aarhus University Hospital
city: Horsens
country: Denmark
facility: Department of Rheumatology, Horsens Regional Hospital
city: Silkeborg
country: Denmark
facility: Diagnostic Centre, Silkeborg Regional Hospital
Study officials:
affiliation: Department of Rheumatology, Aarhus University Hospital
name: Kresten Keller, MD
role: PRINCIPAL_INVESTIGATOR
References: