Status:
UNKNOWN
Study of T Lymphocytes in Patients With Horton Disease
Lead Sponsor:
Centre Hospitalier Universitaire Dijon
Conditions:
Horton Disease
Eligibility:
All Genders
51+ years
Phase:
NA
Brief Summary
Giant-cell arteritis (GCA) is the most frequent vasculitis after 50 years. Corticosteroid therapy is the reference treatment for GCA. This treatment is highly effective but must be maintained for 12 t...
Eligibility Criteria
Inclusion
- PATIENTS
- Patients who have provided written consent
- Patients with national health insurance cover
- Age \> 50 years
- Patients with Horton disease at the diagnosis, before any treatment.
- Horton disease is defined by ACR criteria \[7\], the diagnosis is made in the presence of 3 of the following 5 criteria:
- Age at the onset of the disease of 50 years or older
- Recent-onset localized headache
- Temporal artery tenderness or decreased temporal artery pulse
- Erythrocyte sedimentation rate (ESR) greater than 50 mm in the first hour (or CRP\>20 mg/L)
- Positive temporal artery biopsy (TAB) showing vasculitis with infiltration of mononuclear cells or granulomatous inflammation with or without giant cells.
- Control groups:
- Control Group 1: Healthy subjects Healthy subjects will be matched for age and sex with patients. They will be recruited in Dijon only. They will be healthy volunteers recruited among blood donors, voluntary hospital personnel (nurses, doctors and secretaries) and patients without an infectious or inflammatory disease, or cancer or auto-immune disease (CRP\<5mg/L) recruited in the departments of investigators at the CHU of Dijon Burgundy.
- Control Group 2: (PPR without ACG)
- Patient with oral consent
- Patient affiliated to a social security system
- Age \> 50 years old
- Patient with PPR at diagnosis, before corticosteroid treatment
- No ACG (see protocol definition)
- Control Group 3: (active infection)
- Patient with oral consent
- Patient affiliated to a social security system
- Age \> 50 years old
- Inflammatory syndrome (CRP \> 10 mg/L and fibrinogen\> 4 g/L or CRP \> 10 mg/L and VS \> 30 mm/h) explained by a infectious syndrome defined by the association:
- a fever ≥ 38°C, hypothermia \< 35°C or fever reported by the patient within 72 hours before inclusion
- at least 1 associated clinical and/or radiological sign to an organ infection, for example: pneumopathy, urinary infection, bacterial dermohypodermatitis, infection digestive (non-exhasutive list)
- in the absence of an explanation of the inflammatory syndrome by another cause such as an inflammatory disease or evolutive neoplastic
Exclusion
- Adults under guardianship
- Pregnant or breast-feeding women
- Patients who have been treated with corticosteroids or immunosuppressants in the month preceding inclusion
- Patients treated with chemotherapy, immunosuppressants or biotherapy
- Contra-indication for corticosteroid therapy
- Weight \<41 kg or Hg \<7g/l
Key Trial Info
Start Date :
November 16 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03313102
Start Date
November 16 2017
End Date
November 1 2024
Last Update
September 29 2021
Active Locations (1)
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1
CHU Dijon Bourgogne
Dijon, France, 21079