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

NCT02857192 | Completed

• 1 other identifier: SAMSON APJ 2014
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Horton's Disease

Outcome Measures

Primary Outcomes (1)

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

  through study completion an average of 30 months

Study Arms (2)

Horton

EXPERIMENTAL

Biological: Blood samples

control

PLACEBO COMPARATOR

Biological: Blood samples

Interventions

Blood samples BIOLOGICAL

Horton; control

Eligibility Criteria

• Age: 51 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Adult under guardianship
• Persons without national health insurance cover
• Pregnant or breast-feeding women
• Patients treated with chemotherapy

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

Centre Hospitalier Universitaire

Dijon, 21079, France

Location

Related Publications (2)

• Samson M, Greigert H, Ciudad M, Gerard C, Ghesquiere T, Trad M, Corbera-Bellalta M, Genet C, Ouandji S, Cladiere C, Thebault M, Ly KH, Liozon E, Maurier F, Bienvenu B, Terrier B, Guillevin L, Charles P, Quipourt V, Devilliers H, Gabrielle PH, Creuzot-Garcher C, Tarris G, Martin L, Saas P, Audia S, Cid MC, Bonnotte B. Improvement of Treg immune response after treatment with tocilizumab in giant cell arteritis. Clin Transl Immunology. 2021 Sep 12;10(9):e1332. doi: 10.1002/cti2.1332. eCollection 2021.

  PMID: 34532040 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

Blood Specimen Collection

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

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2016
• First Posted: August 5, 2016
• Study Start: October 5, 2015
• Primary Completion: March 25, 2019
• Study Completion: March 25, 2019
• Last Updated: February 6, 2026

Record last verified: 2026-02

Locations

FR (1)