Study of Phenotypic and Functional Characteristics of Regulatory T Lymphocytes in Horton's Disease

Giant cell arteritis (GCA) is the most frequent vascularitis after 50 years of age The investigators recently showed that GCA was accompanied by an elevation in Th1 and Th17 response [1]. Even though a quantitative deficit in regulatory TL (Treg) was shown, there are to date no data concerning their precise phenotypic and functional characteristics and notably their ability to inhibit Th1 and Th17 polarisation. The hypothesis of the investigator is that, in GCA, there is quantitative and above all functional deficit of Treg. Recently, progress has been made in the identification of Treg with new markers (CD39), which will make it possible to better identify and to study their specific functions. In this study the phenotypic and functional characteristics of Treg in GCA will be analysed. Better understanding of the role des Treg in GCA should lead to better-targeted treatments for patients with GCA, notably via the blockage of cytokines that inhibit the differentiation and/or function of Treg.

The study is classified interventional because a lot of blood samples are taken.

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Key information

Conditions

Horton's Disease Arteritis Autoimmune Diseases Autoimmune Diseases of the Nervous System Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Giant Cell Arteritis Immune System Diseases Nervous System Diseases Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Vascular Diseases Vasculitis Vasculitis, Central Nervous System

Age range

51 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire

Dijon, 21079, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients

Patients who have provided written consent
Patients with national health insurance cover
Age > 50 years
Patients with a diagnosis of Horton's disease, before any treatment

Horton's disease is defined by the American College Rheumatology ACR criteria [2], as the association of 3 of the following 5 criteria:

age at disease onset 50 years or older
recent onset localized headache
indurated temporal artery or diminished/abolition of temporal pulse
erythrocyte sedimentation rate (ESR) greater than 50 mm during the first hour (or C Reactive protein (CRP)>20 mg/L)
Positive temporal artery biopsy (TAB) showing vascularitis with infiltration by mononuclear cells or granulomatous inflammation with or without giant cells.

Control subjects

Control subjects will be healthy volunteers recruited among blood donors at Dijon University Hospital, voluntary hospital personnel (nurses, doctors, laboratory technicians and secretaries) and patients without infectious, inflammatory or auto-immune diseases or cancer (CRP<5mg/L) recruited in the investigating departments of Dijon Hospital. They will be matched for age and sex and must meet the following criteria:

Age > 50 years
Patients with national health insurance cover
Signed written informed consent form
Absence of an inflammatory syndrome (CRP<5 mg /L)

Exclusion criteria

Adult under guardianship
Persons without national health insurance cover
Pregnant or breast-feeding women
Patients treated with corticoids or immunosuppressants in the month preceding inclusion
Patients treated with chemotherapy

Treatment and study plan

blood samples

Biological

Primary outcomes

Measurement by flow cytometry of the percentage of CD39+ Treg (CD4+CD25highFoxP3+CD39+) among total CD4 TL

Time frame: through study completion an average of 30 months

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Official study title

Study of Phenotypic and Functional Characteristics of Regulatory T Lymphocytes in Giant Cell Arteritis (Horton's Disease)

Acronym: ACG et TREG

Important dates

Study start: 2015
Primary completion: 2019
Study completion: 2019
First posted: Aug 5, 2016
Registry last updated: Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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