Polymyalgia Rheumatica and Giant Cell Arteritis

Giant Cell Arteritis Clinical Trial

Official title:

Polymyalgia Rheumatica and Giant Cell Arteritis - Three Challenges - Consequences of the Vasculitis Process, Osteoporosis and Malignancy: A Prospective Cohort Study Protocol

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02985424
• Other study ID #: S-20160098
• Secondary ID: 16/40522
• Status: Not yet recruiting
• Phase: N/A
• First received: December 1, 2016
• Last updated: April 24, 2017
• Start date: May 2017
• Est. completion date: February 2020

Study information

• Verified date: April 2017
• Source: Svendborg Hospital
• Contact: Amir Emamifar, MD
• Phone: +45 71399718
• Email: amir.emamifar[@]rsyd.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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) .

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: February 2020
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Arteritis
• Giant Cell Arteritis
• Polymyalgia Rheumatica

Intervention

Other:
• 18F-FDG PET/CT
18F-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography

Locations

Country	Name	City	State
Denmark	Department of Rheumatology, Odense University Hospital, Svendborg Hospital	Svendborg

Sponsors (2)

Lead Sponsor	Collaborator
Svendborg Hospital	Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulated prednisolone dose within the first year after treatment initiation in patients with and without vasculitis in the large vessels		One year
Secondary	Patient reported global visual analogue scale (VAS) in patients with vasculitis in the large vessels (positive PET)	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	One year
Secondary	Physician reported visual analogue scale (VAS) in patients with vasculitis in the large vessels (positive PET)	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.	One year
Secondary	Patient reported pain in patients with vasculitis in the large vessels (positive PET)	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	One year
Secondary	Morning stiffness (minute) in patients with vasculitis in the large vessels (positive PET)		One year
Secondary	Biochemistry results in patients with vasculitis in the large vessels (positive PET)	ESR, CRP and fibrinogen	One year
Secondary	Number of relapses in patients with vasculitis in the large vessels (positive PET)		One year
Secondary	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
Secondary	Proportion of PET negativity (no signs of vasculitis in the large vessels) in patients with temporal artery biopsy negative.		One year
Secondary	Incidence of malignancies in the included patients detected by the aim of 18F-FDG PET/CT scan.		One year
Secondary	Incidence of malignancies in the included patients detected by the aim of Chest X Ray plus abdominal Ultrasound.		One year
Secondary	Impact of disease process and steroid treatment on Aortic Pulse Wave Velocity (PWV)		One year
Secondary	Impact of disease process and steroid treatment on upper limb PWV		One year
Secondary	Impact of disease process and steroid treatment on Aortic augmentation index		One year
Secondary	Impact of disease process and steroid treatment on Body Mass Index		One year
Secondary	Impact of disease process and steroid treatment on T score		One year
Secondary	Impact of disease process and steroid treatment on Z score		One year
Secondary	Impact of disease process and steroid treatment on Lean Body Mass		One year
Secondary	Impact of disease process and steroid treatment on Fat Mass		One year
Secondary	Impact of disease process and steroid treatment on Bone Mineral Density		One year
Secondary	Impact of disease process and steroid treatment on Bone Mineral Content		One year
Secondary	Impact of disease process and steroid treatment on Fat Free Mass		One year
Secondary	Impact of disease process and steroid treatment on Fat Free Mass Index		One year
Secondary	Impact of disease process and steroid treatment on Fat Mass Index		One year