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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

Tracking Information
First Submitted Date August 17, 2020
First Posted Date August 19, 2020
Last Update Posted Date August 19, 2020
Estimated Study Start Date August 10, 2020
Estimated Primary Completion Date April 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 17, 2020)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: August 17, 2020)
  • 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.
  • 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.
  • 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.
  • 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.
  • Change in PET/CT parameters from baseline to week [ Time Frame: 8 weeks ]
    Change in PET/CT parameters from baseline to week 8.
  • 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.
  • Frequency of adrenal insufficiency at week 10. [ Time Frame: 10 weeks ]
    Frequency of adrenal insufficiency at week 10.
  • 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.
  • 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.
  • Frequency of adrenal insufficiency [ Time Frame: 18 months ]
    Frequency of adrenal insufficiency after 1 and 1.5 years.
  • Lean boyd weight [ Time Frame: 18 months ]
    Lean body weight adjusted prednisolone dose as a predictor of adrenal insufficiency.
  • Hypercortisolism as predictor of adrenal insufficiency. [ Time Frame: 18 months ]
    Clinical and biochemical signs of hypercortisolism as predictor of adrenal insufficiency.
  • Change in clinical parameters week 8. [ Time Frame: 8 weeks ]
    Change in clinical parameters from baseline to week 8.
  • Change in clinical parameters week 10. [ Time Frame: 10 weeks ]
    Change in clinical parameters from week 8 to week 10.
  • Frequency of GCA [ Time Frame: 12 months ]
    Frequency of GCA at diagnosis and during follow up
  • Change in PROM's from baseline to week 8. [ Time Frame: 8 weeks ]
    Change in PROM's from baseline to week 8.
  • Change in PROM's from week 8 to week 10. [ Time Frame: 10 weeks ]
    Change in PROM's from week 8 to week 10.
  • Change in PROM's from baseline to 1 year. [ Time Frame: 12 months ]
    Change in PROM's from baseline to 1 year.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Improved Diagnostics and Monitoring of Polymyalgia Rheumatica
Official Title Improved Diagnostics and Monitoring of Polymyalgia Rheumatica
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
whole blood, plasma, serum
Sampling Method Probability Sample
Study Population The study will include patients suspected for PMR.
Condition
  • Polymyalgia Rheumatica
  • Giant Cell Arteritis
  • Adrenal Insufficiency
Intervention Diagnostic Test: PET/CT
FDG-PET/CT at baseline, week 8 and week 10.
Other Name: Ultrasound
Study Groups/Cohorts 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.
Intervention: Diagnostic Test: PET/CT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 17, 2020)
143
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 1, 2023
Estimated Primary Completion Date April 1, 2023   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Kresten Keller, MD +45 40384984 krekel@rm.dk
Listed Location Countries Denmark
Removed Location Countries  
 
Administrative Information
NCT Number NCT04519580
Other Study ID Numbers IMPROVE PMR
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Kresten Krarup Keller, Central Jutland Regional Hospital
Study Sponsor Kresten Krarup Keller
Collaborators Aarhus University Hospital
Investigators
Principal Investigator: Kresten Keller, MD Diagnostic Center, Silkeborg Regional Hospital, Denmark
PRS Account Central Jutland Regional Hospital
Verification Date August 2020