Giant Cell Arteritis and Anakinra Trial

Minimum Age: 51 Years Maximum Age: Gender: Both Accepts Healthy Volunteers?: No Criteria: Inclusion Criteria: (Giant cell arteritis = GCA) Age ≥ 50 years Patient with temporal arteritis giant cell match 3 of the 5 criteria of the AmericanCollege of Rheumatology (ACR) that: Given a temporal artery biopsy compatible with a diagnosis of GCA (not necrotizingarteritis, giant cell with a granulomatous inflammatory infiltrate, usually localized tothe intima-media junction, makes lymphocytes, macrophages and multinucleated giant cells;or minimum detection of a chronic inflammatory infiltrate fact lymphocytes and someneutrophils or eosinophils without giant cells). Either abdominal thoracic aortitis diagnosed by:

• Angio CT: circumferential thickening of the aortic wall more than 3 mm, in the absenceof adjacent plaque and active infection.

• MR angiography: wall thickening of the aortic wall with hyperintense on T1 weightedand T2 weighted enhancement after gadolinium injection.

• PET scanner: increased uptake of FDG by the aorta and its branches is not typical forGCA and may be in the atheroma. The PET scanner is probably a very sensitive techniquebut not specific enough to retain the diagnosis of GCA. We therefore consider the PETCT as a diagnostic method of secondary aortite the GCA if there simultaneously on thesame exam fixing aortic (thoracic or abdominal) and blood of large caliber (artery (s)axillary ( s), subclavian (s) and / or carotid (s) of FDG. Newly diagnosed disease and from corticosteroid started up to 14 days, the initial dose isless or equal to1 mg / Kg or GCA recurrence of continuous therapy with corticosteroids (including hydroprednisone) and /or immunosuppression was stopped for at least 6 months. At the time of recurrence, at least 3 of 5 ACR criteria for the diagnosis of GCA must be present. Furthermore :

• if BAT (Biopsy of the temporal artery) was positive at the time of initial diagnosis,it is not necessary to make a new.

• if BAT was negative, the patient can not be included after completion of a new BATwhich will be positive or if there is a aortite, evidenced by angio-CT or MRangiography or PET scanner. For men and women of childbearing age, effective contraception must be used in the patientor his partner for the duration of treatment with anakinra (or placebo) and for 3 monthsafter treatment. Also, breastfeeding is allowed after 3 months of stopping anakinra. Womenconsidered not at risk of pregnancy are defined with menopause for at least a year orsurgically sterile (tubal ligation, bilateral oophorectomy or hysterectomy) Patient wo has given its written consent Patient affiliated with a social security

Exclusion Criteria: Subjects checking one of the criteria for non-inclusion may be eligible to participate inthe research. These criteria may include:

1. pathologies, habitus or other patient characteristics

• Pregnancy, breastfeeding women or women of childbearing potential not usingcontraception

• dementia syndrome

• Patient not observing

• Patients who live more than 150 km from the investigation center

• ethyl or drug intoxication history that required hospitalization in the previousyear

• Patient monitoring and / or treated to another autoimmune disease or knowninflammatory

• Hypersensitivity to anakinra or any of its excipients (Sodium citrate (E331),sodium chloride, disodium edetate (E385), polysorbate 80 (E433), sodium hydroxide (E524), water for injections, substrates of origin: Escherichia coli proteins)

• Person under judicial protection, guardianship

• Person deprived of liberty

• Person not beneficiaries of the social security system

2. Other therapeutic

• Patient has already started (or stopped there less than 6 months) in a protocol ornot frame to its ACG or another disease, treatment with anti TNF-alpha, methotrexate,cyclosporine, cyclophosphamide, dapsone or bolus corticosteroids.

• Patients on long-term glucocorticoid for another condition

• Early treatment of CAG disease with a dose> 1 mg / kg whatever the duration

• Immunization with live vaccines / mitigated during the 8 weeks

3. Infectious diseases

• Chronic viral hepatitis (acute or) B or C

• HIV Infection

• Persistent infection or severe infection requiring hospitalization or treatmentwith IV antibiotics during the 30 days prior to inclusion

• Infection requiring an oral antibiotic treatment in the preceding 14 daysinclusion

• History of active tuberculosis, histoplasmosis or listeriosis

• latent TB Signs (based on a history of untreated contagion, an opacity of greaterthan 1 cm in diameter on chest x-ray, or an in vitro test (Quantiferon Gold orT-Spot TB) positive. A history of tuberculosis disease or latent TB whosetreatment is completed and has been properly conducted is not an exclusioncriterion, whatever the result of Quantiferon or T-Spot TB.

4. Unstable disease

• Uncontrolled diabetes with a history of recurrent infections

• unstable ischemic heart

• Heart failure ≥ stage III / IV NYHA

• Stroke recent (<6 months)

• Or any other severe disease resulting in the opinion of the investigator, a riskto the patient due to its participation in the study.

5. A vascular risk, metabolic, infectious, neoplastic renal or as follows:

• Patient at high cardiovascular risk: heart disease or vascular history of proven,type 2 diabetes at high cardiovascular risk *, vascular risk> 20% at 10 years (Framingham equation) Dyslipidemia • severe uncontrolled lipid-lowering therapy

• Active Liver disease and liver failure

• Neutropenia (<1500 / mm3) at the time of the introduction of Kineret / Placebo;and a patient with initial neutropenia may be included in the study if itcorrects under Cortancyl®, and that the experimental treatment (Anakinra-Kineret / PLACEBO) may be commenced within 15 days after prednisone. Neoplasia under 5 years except carcinoma in situ of the cervix and skin cancer (excluding melanoma) with complete excision whose boundaries pass in safe area.

• Severe renal impairment (clearance <30mL / min)

• The high cardiovascular risk patients with diabetes are defined by:

• A kidney disorder (proteinuria> 300mg / 24h or creatinine clearance <60mL / minaccording to Cockroft)

• Or at least two of the following risk factors:

• Men over 50 years, over 60 year old woman

• History of premature coronary disease: myocardial infarction or sudden death inthe father or relative in the first degree male before age 55 and before age 65for females

• Current or quit smoking for less than 3 years

• High blood pressure treated or not

• HDL cholesterol <0.40 g / L regardless of sex

• Microalbuminuria (> 30 mg / 24h) NB: The moderate renal impairment (clearance ≥ 30 mL / min and <50 mL / min) is not here a criterion for non-inclusion, but theappropriate injection KINERET (anakinra) provided daily will be made every twodays.