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

Horton's Disease Clinical Trial

— Horton CD8  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02158208
• Other study ID #: SAMSON APJ 2013
• Status: Completed
• Start date: July 25, 2013
• Est. completion date: January 25, 2016

Study information

• Verified date: February 2024
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 25, 2016
• Est. primary completion date: January 25, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Giant Cell Arteritis
• Horton's Disease
• Polymyalgia Rheumatica

Intervention

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

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

• Blood sample drawn into a 5 mL dry tube

• 16 blood samples drawn into 6 mL heparinized tubes

Locations

Country	Name	City	State
France	CHU de DIJON	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage of cytotoxic T lymphocytes CD8 (CD8+perforin+granzyme B+)		Change from baselines the percentage of cytotoxic T lymphocytes CD8 at 3 months of treatment