Clinical trial: Study of T Lymphocytes in Patients With Horton Disease (NCT03313102)

Eligibility 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
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 51 Years old.


Patient description (medical language): A 61-year-old man comes to the emergency department complaining of an acute vision disturbance. He had an episode of vision disturbance in the right eye that occurred suddenly and resolved spontaneously in 15 minutes. He also has right jaw pain while chewing.  He also complains of fatigue and hip muscle aches over the last several months.  The patient has a history of mild hyperlipidemia that has been controlled by diet and lifestyle modifications.  On examination, his blood pressure is 130/70 mm Hg and pulse is 66/min.  Neurological examination is unremarkable.  Visual examination is also normal. ESR is 103 mm/h. Temporal artery biopsy shows multinuclear giant cells and internal elastic membrane fragmentation.

Patient description (patient's own words): I’m a 61-year-old man and I came to the ER because I had a sudden episode where I couldn’t see out of my right eye. It only lasted about 15 minutes and went away on its own but it really scared me. I’ve also been having pain in my right jaw when I chew. For the past few months I’ve felt really tired and noticed my hips ache a lot. I have a history of mild cholesterol issues but I’ve been managing that with my diet and lifestyle. When the doctors checked me my blood pressure and pulse were normal and my vision and neurological exams didn’t show anything wrong. However they ran some tests and said my ESR levels were very high and a biopsy of my temporal artery showed some inflammation and damage.

Does the patient match the trial criteria? 1