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

NCT02158208 | Completed

• 1 other identifier: SAMSON APJ 2013
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Horton's Disease

Keywords

before any treatment; at the diagnosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Patients with HD

Other: 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

Controls

Other: Blood sample drawn into a 5 mL dry tube; Other: 16 blood samples drawn into 6 mL heparinized tubes

Interventions

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

Patients with HD

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

Patients with HD

Blood sample drawn into a 5 mL dry tube OTHER

Controls

16 blood samples drawn into 6 mL heparinized tubes OTHER

Controls

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients presenting Horton's disease at the diagnosis before any treatment

You may qualify if:

• 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

You may not qualify if:

• Patients treated with chemotherapy

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

CHU de DIJON

Dijon, 21079, France

Location

Related Publications (2)

• Samson M, Ly KH, Tournier B, Janikashvili N, Trad M, Ciudad M, Gautheron A, Devilliers H, Quipourt V, Maurier F, Meaux-Ruault N, Magy-Bertrand N, Manckoundia P, Ornetti P, Maillefert JF, Besancenot JF, Ferrand C, Mesturoux L, Labrousse F, Fauchais AL, Saas P, Martin L, Audia S, Bonnotte B. Involvement and prognosis value of CD8(+) T cells in giant cell arteritis. J Autoimmun. 2016 Aug;72:73-83. doi: 10.1016/j.jaut.2016.05.008. Epub 2016 May 25.

  PMID: 27236507 RESULT

• Maldiney T, Greigert H, Martin L, Benoit E, Creuzot-Garcher C, Gabrielle PH, Chassot JM, Boccara C, Balvay D, Tavitian B, Clement O, Audia S, Bonnotte B, Samson M. Full-field optical coherence tomography for the diagnosis of giant cell arteritis. PLoS One. 2020 Aug 31;15(8):e0234165. doi: 10.1371/journal.pone.0234165. eCollection 2020.

  PMID: 32866179 DERIVED

MeSH Terms

Conditions

Giant Cell Arteritis

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Vasculitis, Central Nervous System; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arteritis; Vasculitis; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2014
• First Posted: June 6, 2014
• Study Start: July 25, 2013
• Primary Completion: January 25, 2016
• Study Completion: January 25, 2016
• Last Updated: March 12, 2026

Record last verified: 2026-03

Locations

FR (1)