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Trial record 34 of 135 for:    GCA

Biomarkers in Giant Cells Arteritis (BioACG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02844023
Recruitment Status : Terminated (recruitment failure)
First Posted : July 26, 2016
Last Update Posted : April 18, 2019
Information provided by (Responsible Party):
University Hospital, Grenoble

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 Phase
Giant Cells Arteritis Behavioral: Clinical evaluation Other: Paraclinical evaluation Device: Imaging Other: Ophthalmologic examination Biological: Dosage of biomarkers Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Biomarkers in Giant Cells Arteritis
Study Start Date : January 2015
Actual Primary Completion Date : January 14, 2019
Actual Study Completion Date : January 14, 2019

Resource links provided by the National Library of Medicine

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.

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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)

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 identifier (NCT number): NCT02844023

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La Tronche, France, 38700
Sponsors and Collaborators
University Hospital, Grenoble
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Principal Investigator: Laurence Bouillet, Professor Grenoble Hospital University


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Responsible Party: University Hospital, Grenoble Identifier: NCT02844023    
Other Study ID Numbers: 38RC15.198
First Posted: July 26, 2016    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Keywords provided by University Hospital, Grenoble:
Horton disease
Additional relevant MeSH terms:
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Polymyalgia Rheumatica
Giant Cell Arteritis
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