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Improved Diagnostics and Monitoring of Polymyalgia Rheumatica

StatusActive, Not Recruiting
PhaseNot specified
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv7
  2. Primary completion date changed from estimate of Jun 30, 2023 to Jul 4, 2023v6
  3. Enrollment target: 101 to 98v5
  4. Trial status: Recruiting to Active, Not Recruitingv4 Show 4 more changesShow less
    • Enrollment target: estimated 143 to confirmed 101
    • Primary completion date: Jun 1, 2023 to Jun 30, 2023
    • Study completion date: Jun 1, 2027 to Jun 30, 2027
    • Site details revised at 3 of 3 sites
  5. Study sites: 2 to 3
    • Primary completion date: Apr 1, 2023 to Jun 1, 2023
    • Study completion date: Oct 1, 2023 to Jun 1, 2027
    • Secondary endpoints: 21 to 28
    v3
  6. Start date changed from estimate of Aug 10, 2020 to Sep 14, 2020v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04519580
Lead Sponsor Kresten Krarup Keller
Collaborators: Aarhus University Hospital
Conditions
(from sponsor)		 Polymyalgia Rheumatica, Giant Cell Arteritis, Adrenal Insufficiency
Related terms Adrenal Insufficiency, Giant Cell Arteritis, Polymyalgia Rheumatica
Enrollment 98 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov