search
Back to results

Study of T Lymphocytes in Patients With Horton Disease (GAMAIT)

Primary Purpose

Horton Disease

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood samples
Sponsored by
Centre Hospitalier Universitaire Dijon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Horton Disease

Eligibility Criteria

51 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

PATIENTS

  • Patients who have provided written consent
  • Patients with national health insurance cover
  • Age > 50 years
  • Patients with Horton disease at the diagnosis, before any treatment.

Horton disease is defined by ACR criteria [7], the diagnosis is made in the presence of 3 of the following 5 criteria:

  • Age at the onset of the disease of 50 years or older
  • Recent-onset localized headache
  • Temporal artery tenderness or decreased temporal artery pulse
  • Erythrocyte sedimentation rate (ESR) greater than 50 mm in the first hour (or CRP>20 mg/L)
  • Positive temporal artery biopsy (TAB) showing vasculitis with infiltration of mononuclear cells or granulomatous inflammation with or without giant cells.

Control groups:

Control Group 1: Healthy subjects Healthy subjects will be matched for age and sex with patients. They will be recruited in Dijon only. They will be healthy volunteers recruited among blood donors, voluntary hospital personnel (nurses, doctors and secretaries) and patients without an infectious or inflammatory disease, or cancer or auto-immune disease (CRP<5mg/L) recruited in the departments of investigators at the CHU of Dijon Burgundy.

Control Group 2: (PPR without ACG)

  • Patient with oral consent
  • Patient affiliated to a social security system
  • Age > 50 years old
  • Patient with PPR at diagnosis, before corticosteroid treatment
  • No ACG (see protocol definition)

Control Group 3: (active infection)

  • Patient with oral consent
  • Patient affiliated to a social security system
  • Age > 50 years old
  • Inflammatory syndrome (CRP > 10 mg/L and fibrinogen> 4 g/L or CRP > 10 mg/L and VS > 30 mm/h) explained by a infectious syndrome defined by the association:
  • a fever ≥ 38°C, hypothermia < 35°C or fever reported by the patient within 72 hours before inclusion
  • at least 1 associated clinical and/or radiological sign to an organ infection, for example: pneumopathy, urinary infection, bacterial dermohypodermatitis, infection digestive (non-exhasutive list)
  • in the absence of an explanation of the inflammatory syndrome by another cause such as an inflammatory disease or evolutive neoplastic

Exclusion Criteria:

  • Adults under guardianship
  • Pregnant or breast-feeding women
  • Patients who have been treated with corticosteroids or immunosuppressants in the month preceding inclusion
  • Patients treated with chemotherapy, immunosuppressants or biotherapy
  • Contra-indication for corticosteroid therapy
  • Weight <41 kg or Hg <7g/l

Sites / Locations

  • CHU Dijon BourgogneRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Horton disease

control

Arm Description

Outcomes

Primary Outcome Measures

Measure the percentage of blood MAIT (CD3+TCRγδ-CD4-Vα7.2+CD161+) among total TL (CD3+) by flow cytometry

Secondary Outcome Measures

Measure the percentage of blood MAIT (CD3+TCRγδ-CD4-Vα7.2+CD161+) among total TL (CD3+) by flow cytometry

Full Information

First Posted
October 13, 2017
Last Updated
September 28, 2021
Sponsor
Centre Hospitalier Universitaire Dijon
search

1. Study Identification

Unique Protocol Identification Number
NCT03313102
Brief Title
Study of T Lymphocytes in Patients With Horton Disease
Acronym
GAMAIT
Official Title
Study of T Lymphocytes in the Mucosa in Giant-cell Arteritis (GCA) - Giant Cell Arteritis and Mucosal Associated Invariant T Cells
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 16, 2017 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Dijon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Giant-cell arteritis (GCA) is the most frequent vasculitis after 50 years. Corticosteroid therapy is the reference treatment for GCA. This treatment is highly effective but must be maintained for 12 to 24 months to avoid relapses, which causes the onset of numerous adverse effects in this elderly population. Currently clinicians have no way to estimate this risk of relapse during the treatment of GCA. Invariant T lymphocytes associated with the mucous membrane (MAIT), whose role in vasculitides has recently been shown and which produce IL-17 and IFN-γ, two key cytokines in the pathophysiology of GCA could be implicated in the pathophysiology of GCA and could constitute a predictive marker of relapse. Our hypothesis is that blood MAIT are recruited in the artery wall in patients with GCA and that the number of circulating MAIT in the blood falls and then returns to normal if the corticoids are effective. Given that it will be necessary to include a large number of patients to show that the persistence of a low number of circulating MAIT in patients treated with corticoids is a predictor of relapse, we propose, as the first step, to carry out a pilot study to obtain preliminary data on these new markers. The study is classified as interventional because a lot of blood samples are taken

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Horton Disease

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Horton disease
Arm Type
Experimental
Arm Title
control
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
blood samples
Intervention Description
sample of 16 blood tubes
Primary Outcome Measure Information:
Title
Measure the percentage of blood MAIT (CD3+TCRγδ-CD4-Vα7.2+CD161+) among total TL (CD3+) by flow cytometry
Time Frame
at inclusion
Secondary Outcome Measure Information:
Title
Measure the percentage of blood MAIT (CD3+TCRγδ-CD4-Vα7.2+CD161+) among total TL (CD3+) by flow cytometry
Time Frame
at 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
51 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: PATIENTS Patients who have provided written consent Patients with national health insurance cover Age > 50 years Patients with Horton disease at the diagnosis, before any treatment. Horton disease is defined by ACR criteria [7], the diagnosis is made in the presence of 3 of the following 5 criteria: Age at the onset of the disease of 50 years or older Recent-onset localized headache Temporal artery tenderness or decreased temporal artery pulse Erythrocyte sedimentation rate (ESR) greater than 50 mm in the first hour (or CRP>20 mg/L) Positive temporal artery biopsy (TAB) showing vasculitis with infiltration of mononuclear cells or granulomatous inflammation with or without giant cells. Control groups: Control Group 1: Healthy subjects Healthy subjects will be matched for age and sex with patients. They will be recruited in Dijon only. They will be healthy volunteers recruited among blood donors, voluntary hospital personnel (nurses, doctors and secretaries) and patients without an infectious or inflammatory disease, or cancer or auto-immune disease (CRP<5mg/L) recruited in the departments of investigators at the CHU of Dijon Burgundy. Control Group 2: (PPR without ACG) Patient with oral consent Patient affiliated to a social security system Age > 50 years old Patient with PPR at diagnosis, before corticosteroid treatment No ACG (see protocol definition) Control Group 3: (active infection) Patient with oral consent Patient affiliated to a social security system Age > 50 years old Inflammatory syndrome (CRP > 10 mg/L and fibrinogen> 4 g/L or CRP > 10 mg/L and VS > 30 mm/h) explained by a infectious syndrome defined by the association: a fever ≥ 38°C, hypothermia < 35°C or fever reported by the patient within 72 hours before inclusion at least 1 associated clinical and/or radiological sign to an organ infection, for example: pneumopathy, urinary infection, bacterial dermohypodermatitis, infection digestive (non-exhasutive list) in the absence of an explanation of the inflammatory syndrome by another cause such as an inflammatory disease or evolutive neoplastic Exclusion Criteria: Adults under guardianship Pregnant or breast-feeding women Patients who have been treated with corticosteroids or immunosuppressants in the month preceding inclusion Patients treated with chemotherapy, immunosuppressants or biotherapy Contra-indication for corticosteroid therapy Weight <41 kg or Hg <7g/l
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maxime SAMSON, MD
Phone
3.80.29.34.32
Ext
+33
Email
maxime.samson@chu-dijon.fr
Facility Information:
Facility Name
CHU Dijon Bourgogne
City
Dijon
ZIP/Postal Code
21079
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maxime SAMSON, MD
Phone
3 80 29 34 32
Ext
+33
Email
maxime.samson@chu-dijon.fr

12. IPD Sharing Statement

Learn more about this trial

Study of T Lymphocytes in Patients With Horton Disease

We'll reach out to this number within 24 hrs