Clinical Drug Experience Knowledgebase

Criteria

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 American College of Rheumatology (ACR) that:

Given a temporal artery biopsy compatible with a diagnosis of GCA (not necrotizing arteritis, giant cell with a granulomatous inflammatory infiltrate, usually localized to the intima-media junction, makes lymphocytes, macrophages and multinucleated giant cells; or minimum detection of a chronic inflammatory infiltrate fact lymphocytes and some neutrophils 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 absence of adjacent plaque and active infection.
MR angiography: wall thickening of the aortic wall with hyperintense on T1 weighted and T2 weighted enhancement after gadolinium injection.
PET scanner: increased uptake of FDG by the aorta and its branches is not typical for GCA and may be in the atheroma. The PET scanner is probably a very sensitive technique but not specific enough to retain the diagnosis of GCA. We therefore consider the PET CT as a diagnostic method of secondary aortite the GCA if there simultaneously on the same 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 is less 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 BAT which will be positive or if there is a aortite, evidenced by angio-CT or MR angiography or PET scanner.

For men and women of childbearing age, effective contraception must be used in the patient or his partner for the duration of treatment with anakinra (or placebo) and for 3 months after treatment. Also, breastfeeding is allowed after 3 months of stopping anakinra. Women considered not at risk of pregnancy are defined with menopause for at least a year or surgically 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 in the research. These criteria may include:

pathologies, habitus or other patient characteristics

Pregnancy, breastfeeding women or women of childbearing potential not using contraception
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 previous year
Patient monitoring and / or treated to another autoimmune disease or known inflammatory
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

Other therapeutic

- Patient has already started (or stopped there less than 6 months) in a protocol or not 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

Infectious diseases

Chronic viral hepatitis (acute or) B or C
HIV Infection
Persistent infection or severe infection requiring hospitalization or treatment with IV antibiotics during the 30 days prior to inclusion
Infection requiring an oral antibiotic treatment in the preceding 14 days inclusion
History of active tuberculosis, histoplasmosis or listeriosis
latent TB Signs (based on a history of untreated contagion, an opacity of greater than 1 cm in diameter on chest x-ray, or an in vitro test (Quantiferon Gold or T-Spot TB) positive. A history of tuberculosis disease or latent TB whose treatment is completed and has been properly conducted is not an exclusion criterion, whatever the result of Quantiferon or T-Spot TB.

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 risk to the patient due to its participation in the study.

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 it corrects 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 / min according 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 in the father or relative in the first degree male before age 55 and before age 65 for 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 the appropriate injection KINERET (anakinra) provided daily will be made every two days.