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

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

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

NCT ID

NCT03313102

First Posted

October 13, 2017

Last Updated

September 28, 2021

Sponsor

Centre Hospitalier Universitaire Dijon

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

Studies a U.S. FDA-regulated Device Product

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

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

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

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