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

Study of T Lymphocytes in the Mucosa in Giant-cell Arteritis (GCA) - Giant Cell Arteritis and Mucosal Associated Invariant T Cells

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

Study Overview

• Status: Recruiting
• Conditions: Horton Disease
• Intervention / Treatment: Biological: blood samples

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maxime SAMSON, MD; Phone Number: +33 3.80.29.34.32; Email: maxime.samson@chu-dijon.fr

Study Locations

• France
  • Dijon, France, 21079
    • Recruiting
    • CHU Dijon Bourgogne
    • Contact: Maxime SAMSON, MD; Phone Number: +33 3 80 29 34 32; Email: maxime.samson@chu-dijon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 49 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: control	Biological: blood samples; sample of 16 blood tubes
Experimental: Horton disease	Biological: blood samples; sample of 16 blood tubes

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Measure the percentage of blood MAIT (CD3+TCRγδ-CD4-Vα7.2+CD161+) among total TL (CD3+) by flow cytometry	at 3 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2017
• Primary Completion (Anticipated): November 1, 2023
• Study Completion (Anticipated): November 1, 2024

Study Registration Dates

• First Submitted: October 13, 2017
• First Submitted That Met QC Criteria: October 13, 2017
• First Posted (Actual): October 18, 2017

Study Record Updates

• Last Update Posted (Actual): September 29, 2021
• Last Update Submitted That Met QC Criteria: September 28, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Skin Diseases; Immune System Diseases; Autoimmune Diseases of the Nervous System; Autoimmune Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Muscular Diseases; Vasculitis; Skin Diseases, Vascular; Vasculitis, Central Nervous System; Arteritis; Polymyalgia Rheumatica; Giant Cell Arteritis
• Other Study ID Numbers: Samson APJ 2016

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No