Clinical Trial: Polymyalgia Rheumatica and Giant Cell Arteritis

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational

Official Title: Polymyalgia Rheumatica and Giant Cell Arteritis - Three Challenges - Consequences of the Vasculitis Process, Osteoporosis and Malignancy: A Pr

Brief Summary: The purpose of this study is to delineate the association of the 18F-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography (18F-FDG PET/CT) detected vasculitis pattern of the large vessels (PET positivity) and the clinical picture of Polymyalgia Rheumatica (PMR)/Giant Cell Arteritis (GCA) .

Detailed Summary:

Introduction:

Polymyalgia Rheumatica (PMR) and Giant Cell Arteritis (GCA) are common inflammatory conditions. The diagnosis of PMR/GCA poses many challenges since there are no specific diagnostic tests. Recent literature emphasizes the ability of 18F-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography (18F-FDG PET/CT) to assess global disease activity and/or inflammation burden. 18F-FDG PET/CT may lead to make diagnosis at an earlier stage than conventional imaging and assess response to therapy. With respect to the management of PMR/GCA, there are three significant areas of concern as follows: Vasculitis process/vascular stiffness, malignancy and osteoporosis.

Methods and Analysis:

Patients: All patients with the suspicion of PMR/GCR will be offered to participate in the study. The current protocol consists of 4 separate studies including: I) The association of clinical picture of PMR/GCA with PET detected vasculitis II) Evaluating validity of 18F-FDG PET/CT scan for diagnosis of PMR/GCA compared to temporal artery biopsy III) Incidence of new diagnosed malignancies in patients with PMR/GCA, or PMR like syndrome with the aim of PET/CT scan and Chest X ray/Abdominal ultrasound IV) Impact of disease process as well as steroid treatment on bone mineral density, body composition and vasculitis/vascular stiffness in PMR/GCA patients.


Sponsor: Svendborg Hospital

Current Primary Outcome: Cumulated prednisolone dose within the first year after treatment initiation in patients with and without vasculitis in the large vessels [ Time Frame: One year ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Patient reported global visual analogue scale (VAS) in patients with vasculitis in the large vessels (positive PET) [ Time Frame: One year ]
    Patient global assessment of disease severity as measured on a visual analogue scale (VAS) that ranges from 0 to 100, in patients with vasculitis in the large vessels detected by PET scan
  • Physician reported visual analogue scale (VAS) in patients with vasculitis in the large vessels (positive PET) [ Time Frame: One year ]
    Physician assessment of disease severity as measured on a visual analogue scale (VAS) that ranges from 0 to 100 in patients with vasculitis in the large vessels detected by PET scan.
  • Patient reported pain in patients with vasculitis in the large vessels (positive PET) [ Time Frame: One year ]
    Patient assessment of pain intensity as measured on a visual analogue scale (VAS) that ranges from 0 to 100, in patients with vasculitis in the large vessels detected by PET scan
  • Morning stiffness (minute) in patients with vasculitis in the large vessels (positive PET) [ Time Frame: One year ]
  • Biochemistry results in patients with vasculitis in the large vessels (positive PET) [ Time Frame: One year ]
    ESR, CRP and fibrinogen
  • Number of relapses in patients with vasculitis in the large vessels (positive PET) [ Time Frame: One year ]
  • Proportion of PET positivity (vasculitis in the large vessels as well as findings compatible with PMR) in patients with temporal artery biopsy positive. [ Time Frame: One year ]
  • Proportion of PET negativity (no signs of vasculitis in the large vessels) in patients with temporal artery biopsy negative. [ Time Frame: One year ]
  • Incidence of malignancies in the included patients detected by the aim of 18F-FDG PET/CT scan. [ Time Frame: One year ]
  • Incidence of malignancies in the included patients detected by the aim of Chest X Ray plus abdominal Ultrasound. [ Time Frame: One year ]
  • Impact of disease process and steroid treatment on Aortic Pulse Wave Velocity (PWV) [ Time Frame: One year ]
  • Impact of disease process and steroid treatment on upper limb PWV [ Time Frame: One year ]
  • Impact of disease process and steroid treatment on Aortic augmentation index [ Time Frame: One year ]
  • Impact of disease process and steroid treatment on Body Mass Index [ Time Frame: One year ]
  • Impact of disease process and steroid treatment on T score [ Time Frame: One year ]
  • Impact of disease process and steroid treatment on Z score [ Time Frame: One year ]
  • Impact of disease process and steroid treatment on Lean Body Mass [ Time Frame: One year ]
  • Impact of disease process and steroid treatment on Fat Mass [ Time Frame: One year ]
  • Impact of disease process and steroid treatment on Bone Mineral Density [ Time Frame: One year ]
  • Impact of disease process and steroid treatment on Bone Mineral Content [ Time Frame: One year ]
  • Impact of disease process and steroid treatment on Fat Free Mass [ Time Frame: One year ]
  • Impact of disease process and steroid treatment on Fat Free Mass Index [ Time Frame: One year ]
  • Impact of disease process and steroid treatment on Fat Mass Index [ Time Frame: One year ]


Original Secondary Outcome:

  • Patient reported visual analogue scale (VAS) in patients with vasculitis in the large vessels (positive PET) [ Time Frame: One year ]
  • Physician reported visual analogue scale (VAS) in patients with vasculitis in the large vessels (positive PET) [ Time Frame: One year ]
  • Patient reported pain in patients with vasculitis in the large vessels (positive PET) [ Time Frame: One year ]
  • Morning stiffness (minute) in patients with vasculitis in the large vessels (positive PET) [ Time Frame: One year ]
  • Biochemistry results in patients with vasculitis in the large vessels (positive PET) [ Time Frame: One year ]
    ESR, CRP and fibrinogen
  • Number of relapses in patients with vasculitis in the large vessels (positive PET) [ Time Frame: One year ]
  • Proportion of PET positivity (vasculitis in the large vessels as well as findings compatible with PMR) in patients with temporal artery biopsy positive. [ Time Frame: One year ]
  • Proportion of PET negativity (no signs of vasculitis in the large vessels) in patients with temporal artery biopsy negative. [ Time Frame: One year ]
  • Incidence of malignancies in the included patients detected by the aim of 18F-FDG PET/CT scan. [ Time Frame: One year ]
  • Incidence of malignancies in the included patients detected by the aim of Chest X Ray plus abdominal Ultrasound. [ Time Frame: One year ]
  • Impact of disease process and steroid treatment on Aortic Pulse Wave Velocity (PWV) [ Time Frame: One year ]
  • Impact of disease process and steroid treatment on upper limb PWV [ Time Frame: One year ]
  • Impact of disease process and steroid treatment on Aortic augmentation index [ Time Frame: One year ]
  • Impact of disease process and steroid treatment on Body Mass Index [ Time Frame: One year ]
  • Impact of disease process and steroid treatment on T score [ Time Frame: One year ]
  • Impact of disease process and steroid treatment on Z score [ Time Frame: One year ]
  • Impact of disease process and steroid treatment on Lean Body Mass [ Time Frame: One year ]
  • Impact of disease process and steroid treatment on Fat Mass [ Time Frame: One year ]
  • Impact of disease process and steroid treatment on Bone Mineral Density [ Time Frame: One year ]
  • Impact of disease process and steroid treatment on Bone Mineral Content [ Time Frame: One year ]
  • Impact of disease process and steroid treatment on Fat Free Mass [ Time Frame: One year ]
  • Impact of disease process and steroid treatment on Fat Free Mass Index [ Time Frame: One year ]
  • Impact of disease process and steroid treatment on Fat Mass Index [ Time Frame: One year ]


Information By: Svendborg Hospital

Dates:
Date Received: December 1, 2016
Date Started: May 2017
Date Completion: February 2020
Last Updated: April 24, 2017
Last Verified: April 2017