Study of T Lymphocytes in Patients With Horton Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 11 October 2021
• Main ID: NCT03313102
• Date of registration: 13/10/2017
• Prospective Registration: Yes
• Primary sponsor: Centre Hospitalier Universitaire Dijon
• Public title: Study of T Lymphocytes in Patients With Horton Disease GAMAIT
• Scientific title: Study of T Lymphocytes in the Mucosa in Giant-cell Arteritis (GCA) - Giant Cell Arteritis and Mucosal Associated Invariant T Cells
• Date of first enrolment: November 16, 2017
• Target sample size: 60
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03313102
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

France

Contacts

• Name: Maxime SAMSON, MD

• Name: Maxime SAMSON, MD

Key inclusion & exclusion criteria

Inclusion Criteria:

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 Criteria:

- 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



Age minimum: 51 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Horton Disease

Intervention(s)

Biological: blood samples

Primary Outcome(s)

Measure the percentage of blood MAIT (CD3+TCR?d-CD4-Va7.2+CD161+) among total TL (CD3+) by flow cytometry [Time Frame: at inclusion]

Secondary Outcome(s)

Measure the percentage of blood MAIT (CD3+TCR?d-CD4-Va7.2+CD161+) among total TL (CD3+) by flow cytometry [Time Frame: at 3 months]

Secondary ID(s)

Samson APJ 2016

Source(s) of Monetary Support

Please refer to primary and secondary sponsors