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

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ClinicalTrials.gov Identifier: NCT02158208
Recruitment Status : Unknown
Verified May 2013 by Centre Hospitalier Universitaire Dijon.
Recruitment status was:  Recruiting
First Posted : June 6, 2014
Last Update Posted : June 6, 2014
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

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.

Condition or disease Intervention/treatment
Horton's Disease 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 Other: Blood sample drawn into a 5 mL dry tube Other: 16 blood samples drawn into 6 mL heparinized tubes

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of the T CD8 Immune Response in Horton's Disease
Study Start Date : July 2013
Estimated Primary Completion Date : July 2015

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. The percentage of cytotoxic T lymphocytes CD8 (CD8+perforin+granzyme B+) [ Time Frame: Change from baselines the percentage of cytotoxic T lymphocytes CD8 at 3 months of treatment ]


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients presenting Horton's disease at the diagnosis before any treatment
Criteria

Inclusion Criteria:

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
  • Absence of inflammatory syndrome (CRP<5 mg /L)

Exclusion Criteria:

  • Any patient not meeting inclusion criteria
  • Patient 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): NCT02158208


Contacts
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Contact: Maxime SAMSON 3.80.29.34.32 ext +33 maxime.samson@chu-dijon.fr

Locations
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France
CHU de DIJON Recruiting
Dijon, France, 21079
Contact: Maxime SAMSON    3.80.29.34.32 ext +33    maxime.samson@chu-dijon.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon

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Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT02158208     History of Changes
Other Study ID Numbers: SAMSON APJ 2013
First Posted: June 6, 2014    Key Record Dates
Last Update Posted: June 6, 2014
Last Verified: May 2013
Keywords provided by Centre Hospitalier Universitaire Dijon:
before any treatment
at the diagnosis
Additional relevant MeSH terms:
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Polymyalgia Rheumatica
Giant Cell Arteritis
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