Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT02857192 |
Date of registration:
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29/06/2016 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Study of Phenotypic and Functional Characteristics of Regulatory T Lymphocytes in Horton's Disease
ACG et TREG |
Scientific title:
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Study of Phenotypic and Functional Characteristics of Regulatory T Lymphocytes in Giant Cell Arteritis (Horton's Disease) |
Date of first enrolment:
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October 5, 2015 |
Target sample size:
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41 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT02857192 |
Study type:
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Interventional |
Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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France
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Key inclusion & exclusion criteria
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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
Age minimum:
51 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Horton's Disease
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Intervention(s)
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Biological: Blood samples
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Primary Outcome(s)
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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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Secondary ID(s)
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SAMSON APJ 2014
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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