Biomarkers in Giant Cells Arteritis

Overview

Giant cells arteritis or Horton disease is a vasculitis that affects great vessels. This is the most frequent vasculitis of the population over the age of 50. This vasculitis is at the origin of an inflammatory infiltrate of arterial tunics, essentially composed of lymphocytes. Clinical signs are a deterioration of general state, unusual cephalgias, jaw pain, scalp hyperesthesia, but can also be serious ischemic complication, especially ophthalmologic with the possibility to go blind. Until now, the standard treatment is a high dosage corticosteroid therapy. Diagnosis is based on criterias of the American College of Rheumatology, dating back to 1990. The relapse rate is important, ranging from 10 to 64 % according to studies. There are also issues of becoming dependent on steroid. So it is important to determine new diagnosis markers and a therapeutic following of giant cells arteritis. With this study several biomarkers of inflammation will be studied in order to determine if one ore many of them have a good sensitivity and special feature for diagnosis and following of giant cells arteritis. The main goal is to determine a new diagnosis marker for giant cells arteritis.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 14, 2019

Interventions

  • Behavioral: Clinical evaluation
    • With questionnaire.
  • Other: Paraclinical evaluation
    • Symptom inflammatory, biomarkers.
  • Device: Imaging
    • Thoraco-abdominal scanner injected or PET scanner if contraindication for scanner.
  • Other: Ophthalmologic examination
  • Biological: Dosage of biomarkers
    • Control patients.

Arms, Groups and Cohorts

  • Other: Patient with giant gells arteritis
    • 50 patients with giant gells arteritis
  • Other: Control patients
    • 50 control patients : blood from French national blood service (EFS)

Clinical Trial Outcome Measures

Primary Measures

  • Biomarkers’s serum sampling
    • Time Frame: 3 minutes
    • For dosage of biomarkers in serum, like serum amyloid A or interleukins.

Participating in This Clinical Trial

Inclusion Criteria

  • Patient suffering from giant cells arteritis. – Inclusion while discovery of symptoms, or during relapse. Exclusion Criteria:

  • Healthy volunteer – Treatment with corticosteroid since more than 8 days for a patient suffering from giant cells arteritis, exept for patients under corticosteroid for a polymyalgia rheumatica. – Other diseases than giant cells arteritis that could introduce an inflammatory symptom, especially a tumoral process in progress or a chronic inflammatory disease (any other one than giant cells arteritis)

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Grenoble
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Laurence Bouillet, Professor, Principal Investigator, Grenoble Hospital University

References

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