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

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ClinicalTrials.gov Identifier: NCT02857192
Recruitment Status : Unknown
Verified July 2016 by Centre Hospitalier Universitaire Dijon.
Recruitment status was:  Recruiting
First Posted : August 5, 2016
Last Update Posted : August 5, 2016
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

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.


Condition or disease Intervention/treatment Phase
Horton's Disease Biological: Blood samples Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Study of Phenotypic and Functional Characteristics of Regulatory T Lymphocytes in Giant Cell Arteritis (Horton's Disease)
Study Start Date : October 2015
Estimated Primary Completion Date : April 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Horton Biological: Blood samples
Placebo Comparator: control Biological: Blood samples



Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   51 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02857192


Contacts
Contact: Maxime SAMSON 03.80.29.34.32 ext 33 maxime.samson@chu-dijon.fr

Locations
France
Centre Hospitalier Universitaire Recruiting
Dijon, France, 21079
Contact: Maxime SAMSON    03 80 29 34 32 ext 33    maxime.samson@chu-dijon.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon

Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT02857192     History of Changes
Other Study ID Numbers: SAMSON APJ 2014
First Posted: August 5, 2016    Key Record Dates
Last Update Posted: August 5, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
Giant Cell Arteritis
Polymyalgia Rheumatica
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
Autoimmune Diseases
Immune System Diseases
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases