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Biomarkers in Giant Cells Arteritis (BioACG)

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ClinicalTrials.gov Identifier: NCT02844023
Recruitment Status : Recruiting
First Posted : July 26, 2016
Last Update Posted : July 26, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment
Giant Cells Arteritis Behavioral: Clinical evaluation Other: Paraclinical evaluation Device: Imaging Other: Ophthalmologic examination Biological: Dosage of biomarkers

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Biomarkers in Giant Cells Arteritis
Study Start Date : October 2015
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Patient with giant gells arteritis
50 patients with giant gells arteritis
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
Control patients
50 control patients : blood from French national blood service (EFS)
Biological: Dosage of biomarkers
Control patients.


Outcome Measures

Primary Outcome Measures :
  1. Biomarkers's serum sampling [ Time Frame: 3 minutes ]
    For dosage of biomarkers in serum, like serum amyloid A or interleukins.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations

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): NCT02844023


Contacts
Contact: Laurence LB Bouillet, Professor 04 76 76 55 13 lbouillet@chu-grenoble.fr
Contact: Anais Dartevel 06 27 27 30 46 adartevel@chu-grenoble.fr

Locations
France
UniversityHospitalGrenoble Recruiting
La Tronche, France, 38700
Contact: Laurence Bouillet, Professor    04 76 76 53 13    lbouillet@chu-grenoble.fr   
Contact: Anais Dartevel    06 27 27 30 46    adartevel@chu-grenoble.fr   
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Principal Investigator: Laurence Bouillet, Professor Grenoble Hospital University
More Information

Publications:

Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT02844023     History of Changes
Other Study ID Numbers: 38RC15.198
First Posted: July 26, 2016    Key Record Dates
Last Update Posted: July 26, 2016
Last Verified: July 2016

Keywords provided by University Hospital, Grenoble:
Arteritis
Biomarker
Horton disease

Additional relevant MeSH terms:
Arteritis
Giant Cell Arteritis
Polymyalgia Rheumatica
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
Autoimmune Diseases
Immune System Diseases
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases