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Biomarkers in Giant Cells Arteritis (BioACG)

Primary Purpose

Giant Cells Arteritis

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Clinical evaluation
Paraclinical evaluation
Imaging
Ophthalmologic examination
Dosage of biomarkers
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Giant Cells Arteritis focused on measuring Arteritis, Biomarker, Horton disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • UniversityHospitalGrenoble

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Patient with giant gells arteritis

Control patients

Arm Description

50 patients with giant gells arteritis

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

Outcomes

Primary Outcome Measures

Biomarkers's serum sampling
For dosage of biomarkers in serum, like serum amyloid A or interleukins.

Secondary Outcome Measures

Full Information

First Posted
July 20, 2016
Last Updated
April 16, 2019
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT02844023
Brief Title
Biomarkers in Giant Cells Arteritis
Acronym
BioACG
Official Title
Biomarkers in Giant Cells Arteritis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Terminated
Why Stopped
recruitment failure
Study Start Date
January 2015 (undefined)
Primary Completion Date
January 14, 2019 (Actual)
Study Completion Date
January 14, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Giant Cells Arteritis
Keywords
Arteritis, Biomarker, Horton disease

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patient with giant gells arteritis
Arm Type
Other
Arm Description
50 patients with giant gells arteritis
Arm Title
Control patients
Arm Type
Other
Arm Description
50 control patients : blood from French national blood service (EFS)
Intervention Type
Behavioral
Intervention Name(s)
Clinical evaluation
Intervention Description
With questionnaire.
Intervention Type
Other
Intervention Name(s)
Paraclinical evaluation
Intervention Description
Symptom inflammatory, biomarkers.
Intervention Type
Device
Intervention Name(s)
Imaging
Intervention Description
Thoraco-abdominal scanner injected or PET scanner if contraindication for scanner.
Intervention Type
Other
Intervention Name(s)
Ophthalmologic examination
Intervention Type
Biological
Intervention Name(s)
Dosage of biomarkers
Intervention Description
Control patients.
Primary Outcome Measure Information:
Title
Biomarkers's serum sampling
Description
For dosage of biomarkers in serum, like serum amyloid A or interleukins.
Time Frame
3 minutes

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurence Bouillet, Professor
Organizational Affiliation
Grenoble Hospital University
Official's Role
Principal Investigator
Facility Information:
Facility Name
UniversityHospitalGrenoble
City
La Tronche
ZIP/Postal Code
38700
Country
France

12. IPD Sharing Statement

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Biomarkers in Giant Cells Arteritis

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