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

Primary Purpose

Horton's Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood samples
Sponsored by
Centre Hospitalier Universitaire Dijon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Horton's Disease

Eligibility Criteria

51 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier Universitaire

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Horton

control

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 29, 2016
Last Updated
March 4, 2020
Sponsor
Centre Hospitalier Universitaire Dijon
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1. Study Identification

Unique Protocol Identification Number
NCT02857192
Brief Title
Study of Phenotypic and Functional Characteristics of Regulatory T Lymphocytes in Horton's Disease
Acronym
ACG et TREG
Official Title
Study of Phenotypic and Functional Characteristics of Regulatory T Lymphocytes in Giant Cell Arteritis (Horton's Disease)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
October 5, 2015 (Actual)
Primary Completion Date
March 25, 2019 (Actual)
Study Completion Date
March 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Dijon

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Horton's Disease

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Horton
Arm Type
Experimental
Arm Title
control
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
Blood samples
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
51 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Centre Hospitalier Universitaire
City
Dijon
ZIP/Postal Code
21079
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
32866179
Citation
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.
Results Reference
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Study of Phenotypic and Functional Characteristics of Regulatory T Lymphocytes in Horton's Disease

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