Biomarkers in Giant Cells Arteritis

NCT02844023 | Terminated

• 1 other identifier: 38RC15.198
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Giant Cells Arteritis

Keywords

Arteritis; Biomarker; Horton disease

Outcome Measures

Primary Outcomes (1)

• Biomarkers's serum sampling

  For dosage of biomarkers in serum, like serum amyloid A or interleukins.

  3 minutes

Study Arms (2)

Patient with giant gells arteritis

OTHER

50 patients with giant gells arteritis

Behavioral: Clinical evaluation; Other: Paraclinical evaluation; Device: Imaging; Other: Ophthalmologic examination

Control patients

OTHER

50 control patients : blood from French national blood service (EFS)

Biological: Dosage of biomarkers

Interventions

Clinical evaluation BEHAVIORAL

With questionnaire.

Patient with giant gells arteritis

Paraclinical evaluation OTHER

Symptom inflammatory, biomarkers.

Patient with giant gells arteritis

Imaging DEVICE

Thoraco-abdominal scanner injected or PET scanner if contraindication for scanner.

Patient with giant gells arteritis

Ophthalmologic examination OTHER

Patient with giant gells arteritis

Dosage of biomarkers BIOLOGICAL

Control patients.

Control patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient suffering from giant cells arteritis.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

UniversityHospitalGrenoble

La Tronche, 38700, France

Location

Related Publications (25)

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• Salvarani C, Magnani L, Catanoso M, Pipitone N, Versari A, Dardani L, Pulsatelli L, Meliconi R, Boiardi L. Tocilizumab: a novel therapy for patients with large-vessel vasculitis. Rheumatology (Oxford). 2012 Jan;51(1):151-6. doi: 10.1093/rheumatology/ker296. Epub 2011 Nov 10.

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MeSH Terms

Conditions

Arteritis; Giant Cell Arteritis

Interventions

Diagnostic Imaging

Condition Hierarchy (Ancestors)

Vasculitis; Vascular Diseases; Cardiovascular Diseases; Vasculitis, Central Nervous System; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Laurence Bouillet, Professor

  Grenoble Hospital University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2016
• First Posted: July 26, 2016
• Study Start: January 1, 2015
• Primary Completion: January 14, 2019
• Study Completion: January 14, 2019
• Last Updated: April 18, 2019

Record last verified: 2019-04

Locations

FR (1)