Clinical trial: Study of the T CD8 Immune Response in Horton's Disease (NCT02158208)

Eligibility criteria:
Inclusion Criteria:

        Patients

          -  Patients who have provided written informed consent

          -  Patients covered by national health insurance

          -  Age > 50 years

          -  Patients with Horton's disease at the diagnosis before any treatment

        Horton's disease is defined by American College of Rheumatology criteria, the diagnosis is
        made if any 3 of the following 5 criteria are associated:

          -  age at the onset of the disease 50 years or above

          -  recent onset localised headache

          -  indurated temporal artery or decrease/absence of temporal pulse

          -  erythrocyte sedimentation rate (ESR) above 50 mm for the first hour (or CRP>20 mg/L)

          -  positive TAB showing vascularitis with infiltration of mononucleated cells or
             granulomatous inflammation with or without giant cells.

        Controls Controls will be healthy volunteers recruited from blood donors of Dijon CHU,
        voluntary hospital personnel (nurses, doctors, laboratory technicians and secretaries) and
        patients without infectious or inflammatory disease, cancer or auto-immune disease
        (CRP<5mg/L) recruited in the department of the investigators at Dijon CHU. They will be
        matched for age and sex.

          -  Age > 50 years

          -  Patients covered by national health insurance

          -  who have provided written informed consent to take part

          -  Absence of inflammatory syndrome (CRP<5 mg /L)

        Exclusion Criteria:

          -  Any patient not meeting inclusion criteria

          -  Patient treated with corticoids or immunosuppressants in the month preceding inclusion

          -  Patients treated with chemotherapy
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 50 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