Polymyalgia Rheumatica and Giant Cell Arteritis

• Conditions: Polymyalgia Rheumatica; Giant Cell Arteritis

• Registration Number: NCT02985424
• Lead Sponsor: Svendborg Hospital

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 Description

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.

Study Timeline

• Study First Submitted: 2016-12-01
• Study First Submitted QC: 2016-12-02
• Study First Posted: 2016-12-07
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-24
• Last Update Posted: 2017-04-25
• Study Start: 2017-05
• Primary Completion: 2018-02
• Study Completion: 2020-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• At least five (A-E) components of the PMR diagnostic criteria, including:

  • A. Age ≥50 years,
  • B. Bilateral shoulder or hip pain,
  • C. Morning stiffness lasting >45 min,
  • D. Elevated erythrocyte sedimentation rate (ESR),
  • E. Elevated C-reactive protein (CRP),
  • F. Disease duration >2weeks, should be met to suspect PMR.

• For GCA following criteria's must be seen: Age > 50 years, ESR/CRP > 50, as well as at least two symptoms related to vasculitis (scalp tenderness, vision disturbances, headache (new or changed), jaw claudication, tenderness of the temporal arteria) if patients do not simultaneously have PMR. If the patient is suspected for PMR, one cranial symptom is enough to suspect GCA.

Exclusion Criteria

• Dementia
• Inability to communicate in Danish
• Infections or malignancy when prednisolone is permanently unsuitable
• Contraindication to imaging studies (allergy to contrast materials, reduced kidney function, pregnancy and Blood Sugar (BS) >8 mmol/l after 6 hours fasting)
• Initiation of steroid treatment before the PET scan
• Inability to provide informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cumulated prednisolone dose within the first year after treatment initiation in patients with and without vasculitis in the large vessels	One year

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Rheumatology, Odense University Hospital, Svendborg Hospital; 🇩🇰 Svendborg, Denmark