Improved Diagnostics and Monitoring of Polymyalgia Rheumatica

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

98 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-14

Study Completion Date

2027-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Polymyalgia Rheumatica Giant Cell Arteritis Adrenal Insufficiency

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

PET/CT

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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PET/CT

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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Ultrasound

Eligibility Criteria

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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.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No