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Polymyalgia Rheumatica and Giant Cell Arteritis

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ClinicalTrials.gov Identifier: NCT02985424
Recruitment Status : Not yet recruiting
First Posted : December 7, 2016
Last Update Posted : April 25, 2017
Sponsor:
Collaborator:
Odense University Hospital
Information provided by (Responsible Party):
Amir Emamifar, 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) .

Condition or disease Intervention/treatment
Polymyalgia Rheumatica Giant Cell Arteritis 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.


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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Polymyalgia Rheumatica and Giant Cell Arteritis - Three Challenges - Consequences of the Vasculitis Process, Osteoporosis and Malignancy: A Prospective Cohort Study Protocol
Estimated Study Start Date : May 2017
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : February 2020



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


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

Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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

  4. Morning stiffness (minute) in patients with vasculitis in the large vessels (positive PET) [ Time Frame: One year ]
  5. Biochemistry results in patients with vasculitis in the large vessels (positive PET) [ Time Frame: One year ]
    ESR, CRP and fibrinogen

  6. Number of relapses in patients with vasculitis in the large vessels (positive PET) [ Time Frame: One year ]
  7. 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 ]
  8. Proportion of PET negativity (no signs of vasculitis in the large vessels) in patients with temporal artery biopsy negative. [ Time Frame: One year ]
  9. Incidence of malignancies in the included patients detected by the aim of 18F-FDG PET/CT scan. [ Time Frame: One year ]
  10. Incidence of malignancies in the included patients detected by the aim of Chest X Ray plus abdominal Ultrasound. [ Time Frame: One year ]
  11. Impact of disease process and steroid treatment on Aortic Pulse Wave Velocity (PWV) [ Time Frame: One year ]
  12. Impact of disease process and steroid treatment on upper limb PWV [ Time Frame: One year ]
  13. Impact of disease process and steroid treatment on Aortic augmentation index [ Time Frame: One year ]
  14. Impact of disease process and steroid treatment on Body Mass Index [ Time Frame: One year ]
  15. Impact of disease process and steroid treatment on T score [ Time Frame: One year ]
  16. Impact of disease process and steroid treatment on Z score [ Time Frame: One year ]
  17. Impact of disease process and steroid treatment on Lean Body Mass [ Time Frame: One year ]
  18. Impact of disease process and steroid treatment on Fat Mass [ Time Frame: One year ]
  19. Impact of disease process and steroid treatment on Bone Mineral Density [ Time Frame: One year ]
  20. Impact of disease process and steroid treatment on Bone Mineral Content [ Time Frame: One year ]
  21. Impact of disease process and steroid treatment on Fat Free Mass [ Time Frame: One year ]
  22. Impact of disease process and steroid treatment on Fat Free Mass Index [ Time Frame: One year ]
  23. Impact of disease process and steroid treatment on Fat Mass Index [ Time Frame: One year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All new patients with clinical suspicion of PMR/GCA.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02985424


Contacts
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Contact: Amir Emamifar, MD +45 71399718 amir.emamifar@rsyd.dk
Contact: Inger Marie Jensen Hansen, PhD, DMSci +45 63202506 inger.marie.jensen.hansen@rsyd.dk

Locations
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Denmark
Department of Rheumatology, Odense University Hospital, Svendborg Hospital Not yet recruiting
Svendborg, Denmark, 5700
Contact: Inger Marie Jensen Hansen, PhD, DMSci    +45 63202506    inger.marie.jensen.hansen@rsyd.dk   
Sponsors and Collaborators
Svendborg Hospital
Odense University Hospital
Investigators
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Study Chair: Inger Marie Jensen Hansen, Phd, DMSci Department of Rheumatology, Odense University Hospital, Svendborg Hospital, Svendborg, Denmark.

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Responsible Party: Amir Emamifar, Doctor of Medicine, Svendborg Hospital
ClinicalTrials.gov Identifier: NCT02985424     History of Changes
Other Study ID Numbers: S-20160098
16/40522 ( Other Identifier: Danish Data Protection Agency )
First Posted: December 7, 2016    Key Record Dates
Last Update Posted: April 25, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Vasculitis
Vasculitis, Central Nervous System
Arteritis
Giant Cell Arteritis
Polymyalgia Rheumatica
Vascular Diseases
Cardiovascular Diseases
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Skin Diseases, Vascular
Skin Diseases
Autoimmune Diseases
Immune System Diseases
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases