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Improved Diagnostics and Monitoring of Polymyalgia Rheumatica

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ClinicalTrials.gov Identifier: NCT04519580
Recruitment Status : Recruiting
First Posted : August 19, 2020
Last Update Posted : August 19, 2020
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
Kresten Krarup Keller, Central Jutland Regional Hospital

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.


Condition or disease Intervention/treatment
Polymyalgia Rheumatica Giant Cell Arteritis Adrenal Insufficiency Diagnostic Test: PET/CT

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Study Type : Observational
Estimated Enrollment : 143 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Improved Diagnostics and Monitoring of Polymyalgia Rheumatica
Estimated Study Start Date : August 10, 2020
Estimated Primary Completion Date : April 1, 2023
Estimated Study Completion Date : October 1, 2023


Group/Cohort Intervention/treatment
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
FDG-PET/CT at baseline, week 8 and week 10.
Other Name: Ultrasound




Primary Outcome Measures :
  1. PMR diagnosis at baseline with PET/CT [ Time Frame: Baseline ]
    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.


Secondary Outcome Measures :
  1. PMR diagnosis at week 8 with PET/CT [ Time Frame: 8 weeks ]
    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.

  2. PMR diagnosis at week 10 with PET/CT [ Time Frame: 10 weeks ]
    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.

  3. Change in Ultrasound parameters from baseline to week 8 [ Time Frame: 8 weeks ]
    Change in presence and thickness of subdeltoid bursitis and biceps tenosynovitis from baseline to week 8.

  4. Change in Ultrasound parameters from week 8 to week 10 [ Time Frame: 10 weeks ]
    Change in presence and thickness of subdeltoid bursitis and biceps tenosynovitis from week 8 to week 10.

  5. Change in PET/CT parameters from baseline to week [ Time Frame: 8 weeks ]
    Change in PET/CT parameters from baseline to week 8.

  6. Change in PET/CT parameters from week 8 to week 10. [ Time Frame: 10 weeks ]
    Change in PET/CT parameters from week 8 to week 10.

  7. Frequency of adrenal insufficiency at week 10. [ Time Frame: 10 weeks ]
    Frequency of adrenal insufficiency at week 10.

  8. 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 prednisolone cessation at one year.

  9. Presence of adrenal insufficiency at week 10 as a predictor of relapse at week 10. [ Time Frame: 10 weeks ]
    Presence of adrenal insufficiency at week 10 as a predictor of relapse at week 10.

  10. Frequency of adrenal insufficiency [ Time Frame: 18 months ]
    Frequency of adrenal insufficiency after 1 and 1.5 years.

  11. Lean boyd weight [ Time Frame: 18 months ]
    Lean body weight adjusted prednisolone dose as a predictor of adrenal insufficiency.

  12. Hypercortisolism as predictor of adrenal insufficiency. [ Time Frame: 18 months ]
    Clinical and biochemical signs of hypercortisolism as predictor of adrenal insufficiency.

  13. Change in clinical parameters week 8. [ Time Frame: 8 weeks ]
    Change in clinical parameters from baseline to week 8.

  14. Change in clinical parameters week 10. [ Time Frame: 10 weeks ]
    Change in clinical parameters from week 8 to week 10.

  15. Frequency of GCA [ Time Frame: 12 months ]
    Frequency of GCA at diagnosis and during follow up

  16. Change in PROM's from baseline to week 8. [ Time Frame: 8 weeks ]
    Change in PROM's from baseline to week 8.

  17. Change in PROM's from week 8 to week 10. [ Time Frame: 10 weeks ]
    Change in PROM's from week 8 to week 10.

  18. Change in PROM's from baseline to 1 year. [ Time Frame: 12 months ]
    Change in PROM's from baseline to 1 year.

  19. Sensitivity and specificity of CRP for PMR diagnosis at week 10. [ Time Frame: 10 weeks ]
    Sensitivity and specificity of CRP for PMR diagnosis at week 10.

  20. Level of inflammatory markers in PMR patients at baseline vs. week 8. [ Time Frame: 8 weeks ]
    Level of inflammatory markers in PMR patients at baseline vs. week 8.

  21. Level of inflammatory markers in PMR patients vs. non PMR patients at baseline. [ Time Frame: Baseline ]
    Level of inflammatory markers in PMR patients vs. non PMR patients at baseline.


Biospecimen Retention:   Samples With DNA
whole blood, plasma, serum


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study will include patients suspected for PMR.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04519580


Contacts
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Contact: Kresten Keller, MD +45 40384984 krekel@rm.dk

Locations
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Denmark
Department of Rheumatology, Aarhus University Hospital Recruiting
Aarhus, Denmark, 8200
Contact: Ib Hansen, MD       ib.hansen@aarhus.rm.dk   
Diagnostic Center, Silkeborg Regional Hospital Recruiting
Silkeborg, Denmark, 8600
Contact: Kresten Keller, MD    40384984    krekel@rm.dk   
Sponsors and Collaborators
Kresten Krarup Keller
Aarhus University Hospital
Investigators
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Principal Investigator: Kresten Keller, MD Diagnostic Center, Silkeborg Regional Hospital, Denmark
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Responsible Party: Kresten Krarup Keller, MD, PhD, Central Jutland Regional Hospital
ClinicalTrials.gov Identifier: NCT04519580    
Other Study ID Numbers: IMPROVE PMR
First Posted: August 19, 2020    Key Record Dates
Last Update Posted: August 19, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kresten Krarup Keller, Central Jutland Regional Hospital:
Positron emission computed tomography
Ultrasound
Additional relevant MeSH terms:
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Polymyalgia Rheumatica
Giant Cell Arteritis
Arteritis
Adrenal Insufficiency
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Adrenal Gland Diseases
Endocrine System Diseases
Vasculitis, Central Nervous System
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Skin Diseases, Vascular
Skin Diseases
Autoimmune Diseases
Immune System Diseases
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases