Clinical trial: Study of Phenotypic and Functional Characteristics of Regulatory T Lymphocytes in Horton's Disease (NCT02857192)

Eligibility criteria:
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
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
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