Study of Phenotypic and Functional Characteristics of Regulatory T Lymphocytes in Horton's Disease (ACG et TREG)

February 4, 2026 updated by: Centre Hospitalier Universitaire Dijon

Study of Phenotypic and Functional Characteristics of Regulatory T Lymphocytes in Giant Cell Arteritis (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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Dijon, France, 21079
        • Centre Hospitalier Universitaire

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

51 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: control
Biological: Blood samples
Experimental: Horton
Biological: Blood samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
through study completion an average of 30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 5, 2015

Primary Completion (Actual)

March 25, 2019

Study Completion (Actual)

March 25, 2019

Study Registration Dates

First Submitted

June 29, 2016

First Submitted That Met QC Criteria

August 2, 2016

First Posted (Estimated)

August 5, 2016

Study Record Updates

Last Update Posted (Actual)

February 6, 2026

Last Update Submitted That Met QC Criteria

February 4, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAMSON APJ 2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Horton's Disease

Clinical Trials on Blood samples

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ecuador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe