Improved Diagnostics and Monitoring of Polymyalgia Rheumatica

N/AActive Not RecruitingNCT04519580

Kresten Krarup Keller98 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Polymyalgia Rheumatica Giant Cell Arteritis Adrenal Insufficiency

Interventions

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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.

Locations (3)

Department of Rheumatology, Aarhus University Hospital

Aarhus, Denmark

Department of Rheumatology, Horsens Regional Hospital

Horsens, Denmark

Diagnostic Centre, Silkeborg Regional Hospital

Silkeborg, Denmark

Outcomes

Primary Outcomes

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.

Time frame: Baseline

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 10 weeks

Change in PET/CT parameters from baseline to week

Change in PET/CT parameters from baseline to week 8.

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

Frequency of adrenal insufficiency after 1 and 1.5 years.

Time frame: 18 months

Lean boyd weight

Lean body weight adjusted prednisolone dose as a predictor of adrenal insufficiency.

Time frame: 18 months

Hypercortisolism as predictor of adrenal insufficiency.

Clinical and biochemical signs of hypercortisolism as predictor of adrenal insufficiency.

Time frame: 18 months

Change in clinical parameters week 8.

Change in clinical parameters from baseline to week 8.

Time frame: 8 weeks

Change in clinical parameters week 10.

Change in clinical parameters from week 8 to week 10.

Time frame: 10 weeks

Frequency of GCA

Frequency of GCA at diagnosis and during follow up

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.

PET/CT measures at baseline is measured with Standard Uptake Value and dichrotone evaluation for PMR (PMR +/-)

Time frame: 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.

Time frame: 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.

Time frame: 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)

Time frame: 5 Years