Study of the T CD8 Immune Response in Horton's Disease

The research hypothesis is that T lymphocytes CD8 play a role in the physiopathology of Horton's disease.

At the inclusion visit, patients will have, as is the case in the usual strategy:

* A complete clinical examination carried out by the doctor in charge of the patient * ESR, and CRP and fibrinogen assay * A full blood count for leukocytes and lymphocytes * A biopsy of the temporal artery (TAB) to screen for signs of vascularitis, suggesting Horton's disease. The clinician in charge of the patient will decide if a second biopsy is necessary. The biopsy will be sent to and analysed at Anatomy and Pathological cytology service. Immunohistochemical analyses will be done if the TAB is positive.

In addition to the standard clinical examination and complementary examinations relative to the patients' pathology, the following will be done:

* Lymphocyte immunophenotyping for the quantity of T CD4 (cluster of differentiation 4) and CD8 lymphocytes, B lymphocytes and natural killer lymphocytes. This will make it possible to calculate the absolute value for different T lymphocyte populations. * A blood sample drawn into a dry 5 mL tube (large yellow) to isolate the serum, which will be stored at -80°C for future assays for cytokines and other biomarkers of interest for Horton's disease. * 16 blood samples drawn into 6 mL heparinized tubes (large green). These will be used immediately for cytometric and functional analyses.

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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

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de DIJON

Dijon, 21079, France

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Patients

Patients who have provided written informed consent
Patients covered by national health insurance
Age > 50 years
Patients with Horton's disease at the diagnosis before any treatment

Horton's disease is defined by American College of Rheumatology criteria, the diagnosis is made if any 3 of the following 5 criteria are associated:

age at the onset of the disease 50 years or above
recent onset localised headache
indurated temporal artery or decrease/absence of temporal pulse
erythrocyte sedimentation rate (ESR) above 50 mm for the first hour (or CRP>20 mg/L)
positive TAB showing vascularitis with infiltration of mononucleated cells or granulomatous inflammation with or without giant cells.

Controls Controls will be healthy volunteers recruited from blood donors of Dijon CHU, voluntary hospital personnel (nurses, doctors, laboratory technicians and secretaries) and patients without infectious or inflammatory disease, cancer or auto-immune disease (CRP<5mg/L) recruited in the department of the investigators at Dijon CHU. They will be matched for age and sex.

Age > 50 years
Patients covered by national health insurance
who have provided written informed consent to take part
Absence of inflammatory syndrome (CRP<5 mg /L)

Exclusion criteria

Any patient not meeting inclusion criteria
Patient treated with corticoids or immunosuppressants in the month preceding inclusion
Patients treated with chemotherapy

Treatment and study plan

Blood sample drawn into a 5 mL dry tube at the diagnosis and after 3 months of treatment

Other

16 blood samples drawn into 6 mL heparinized tubes at the diagnosis and after 3 months of treatment

Other

Blood sample drawn into a 5 mL dry tube

Other

16 blood samples drawn into 6 mL heparinized tubes

Other

Primary outcomes

The percentage of cytotoxic T lymphocytes CD8 (CD8+perforin+granzyme B+)

Time frame: Change from baselines the percentage of cytotoxic T lymphocytes CD8 at 3 months of treatment

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Acronym: Horton CD8

Important dates

Study start: 2013
Primary completion: 2016
Study completion: 2016
First posted: Jun 6, 2014
Registry last updated: Mar 12, 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.

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