Improved Diagnostics and Monitoring of Polymyalgia Rheumatica

Adrenal Insufficiency Clinical Trial

Official title:

Improved Diagnostics and Monitoring of Polymyalgia Rheumatica

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04519580
• Other study ID #: IMPROVE PMR
• Status: Active, not recruiting
• Start date: September 14, 2020
• Est. completion date: June 30, 2027

Study information

• Verified date: September 2023
• Source: Central Jutland Regional Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 98
• Est. completion date: June 30, 2027
• Est. primary completion date: July 4, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adrenal Insufficiency
• Arteritis
• Giant Cell Arteritis
• Polymyalgia Rheumatica

Intervention

Diagnostic Test:
• PET/CT
FDG-PET/CT at baseline, week 8 and week 10.

Locations

Country	Name	City	State
Denmark	Department of Rheumatology, Aarhus University Hospital	Aarhus
Denmark	Department of Rheumatology, Horsens Regional Hospital	Horsens
Denmark	Diagnostic Centre, Silkeborg Regional Hospital	Silkeborg

Sponsors (2)

Lead Sponsor	Collaborator
Kresten Krarup Keller	Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	8 weeks
Secondary	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.	10 weeks
Secondary	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.	8 weeks
Secondary	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.	10 weeks
Secondary	Change in PET/CT parameters from baseline to week	Change in PET/CT parameters from baseline to week 8.	8 weeks
Secondary	Change in PET/CT parameters from week 8 to week 10.	Change in PET/CT parameters from week 8 to week 10.	10 weeks
Secondary	Frequency of adrenal insufficiency at week 10.	Frequency of adrenal insufficiency at week 10.	10 weeks
Secondary	Presence of adrenal insufficiency at week 10 as a predictor of prednisolone cessation at one year.	Presence of adrenal insufficiency at week 10 as a predictor of prednisolone cessation at one year.	12 months
Secondary	Presence of adrenal insufficiency at week 10 as a predictor of relapse at week 10.	Presence of adrenal insufficiency at week 10 as a predictor of relapse at week 10.	10 weeks
Secondary	Frequency of adrenal insufficiency	Frequency of adrenal insufficiency after 1 and 1.5 years.	18 months
Secondary	Lean boyd weight	Lean body weight adjusted prednisolone dose as a predictor of adrenal insufficiency.	18 months
Secondary	Hypercortisolism as predictor of adrenal insufficiency.	Clinical and biochemical signs of hypercortisolism as predictor of adrenal insufficiency.	18 months
Secondary	Change in clinical parameters week 8.	Change in clinical parameters from baseline to week 8.	8 weeks
Secondary	Change in clinical parameters week 10.	Change in clinical parameters from week 8 to week 10.	10 weeks
Secondary	Frequency of GCA	Frequency of GCA at diagnosis and during follow up	12 months
Secondary	Change in PROM's from baseline to week 8.	Change in PROM's from baseline to week 8.	8 weeks
Secondary	Change in PROM's from week 8 to week 10.	Change in PROM's from week 8 to week 10.	10 weeks
Secondary	Change in PROM's from baseline to 1 year.	Change in PROM's from baseline to 1 year.	12 months
Secondary	Sensitivity and specificity of CRP for PMR diagnosis at week 10.	Sensitivity and specificity of CRP for PMR diagnosis at week 10.	10 weeks
Secondary	Level of inflammatory markers in PMR patients at baseline vs. week 8.	Level of inflammatory markers in PMR patients at baseline vs. week 8.	8 weeks
Secondary	Level of inflammatory markers in PMR patients vs. non PMR patients at baseline.	Level of inflammatory markers in PMR patients vs. non PMR patients at baseline.	Baseline
Secondary	Change in expression levels of clock gene mRNA as marker of prednisolone-induced changes in sleep, lipid levels and glycated hemoglobin.	Change in expression levels of clock gene mRNA as marker of prednisolone-induced changes in sleep, lipid levels and glycated hemoglobin.	1 year
Secondary	Percentage of patients with concomitant GCA and PMR after 3 and 5 years.	Percentage of patients with concomitant GCA and PMR after 3 and 5 years.	5 Years
Secondary	Percentage of patients receiving prednisolone after 3 and 5 years.	Percentage of patients receiving prednisolone after 3 and 5 years.	5 Years
Secondary	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 +/-)	5 Years
Secondary	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.	5 Years
Secondary	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.	5 Years
Secondary	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)	5 Years