Polymyalgia Rheumatica and Giant Cell Arteritis

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

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) .

Study Overview

• Status: Unknown
• Conditions: Giant Cell Arteritis; Polymyalgia Rheumatica
• Intervention / Treatment: Other: 18F-FDG PET/CT

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 Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

• Study Contact: Name: Amir Emamifar, MD; Phone Number: +45 71399718; Email: amir.emamifar@rsyd.dk
• Study Contact Backup: Name: Inger Marie Jensen Hansen, PhD, DMSci; Phone Number: +45 63202506; Email: inger.marie.jensen.hansen@rsyd.dk

Study Locations

• Denmark
  • Svendborg, Denmark, 5700
    • Department of Rheumatology, Odense University Hospital, Svendborg Hospital
    • Contact: Inger Marie Jensen Hansen, PhD, DMSci; Phone Number: +45 63202506; Email: inger.marie.jensen.hansen@rsyd.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 93 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All new patients with clinical suspicion of PMR/GCA.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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
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
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
Morning stiffness (minute) in patients with vasculitis in the large vessels (positive PET)		One year
Biochemistry results in patients with vasculitis in the large vessels (positive PET)	ESR, CRP and fibrinogen	One year
Number of relapses in patients with vasculitis in the large vessels (positive PET)		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
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
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 upper limb PWV		One year
Impact of disease process and steroid treatment on Aortic augmentation index		One year
Impact of disease process and steroid treatment on Body Mass Index		One year
Impact of disease process and steroid treatment on T score		One year
Impact of disease process and steroid treatment on Z score		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
Impact of disease process and steroid treatment on Bone Mineral Density		One year
Impact of disease process and steroid treatment on Bone Mineral Content		One year
Impact of disease process and steroid treatment on Fat Free Mass		One year
Impact of disease process and steroid treatment on Fat Free Mass Index		One year
Impact of disease process and steroid treatment on Fat Mass Index		One year

Collaborators and Investigators

• Sponsor: Svendborg Hospital
• Collaborators: Odense University Hospital
• Investigators: Study Chair: Inger Marie Jensen Hansen, Phd, DMSci, Department of Rheumatology, Odense University Hospital, Svendborg Hospital, Svendborg, Denmark.

Publications and helpful links

General Publications

• Emamifar A, Hess S, Ellingsen T, Gerke O, Ahangarani Farahani Z, Syrak Hansen P, Jensen Hansen IM, Thye-Ronn P. Clinical presentation and treatment response in patients with polymyalgia rheumatica and giant cell arteritis during a 40-week follow-up. Rheumatol Adv Pract. 2021 Nov 24;5(3):rkab091. doi: 10.1093/rap/rkab091. eCollection 2021.

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2017
• Primary Completion (Anticipated): February 1, 2018
• Study Completion (Anticipated): February 1, 2020

Study Registration Dates

• First Submitted: December 1, 2016
• First Submitted That Met QC Criteria: December 2, 2016
• First Posted (Estimate): December 7, 2016

Study Record Updates

• Last Update Posted (Actual): April 25, 2017
• Last Update Submitted That Met QC Criteria: April 24, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Skin Diseases; Immune System Diseases; Autoimmune Diseases of the Nervous System; Autoimmune Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Muscular Diseases; Vasculitis; Skin Diseases, Vascular; Vasculitis, Central Nervous System; Polymyalgia Rheumatica; Giant Cell Arteritis; Arteritis; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; Fluorodeoxyglucose F18
• Other Study ID Numbers: S-20160098; 16/40522 (Other Identifier: Danish Data Protection Agency)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No