NCT lookup

Inclusion Criteria:

* Age \> 60 years
* Diagnosis of
* GCA (according to ACR criteria or positive temporal artery biopsy) (de novo and/or relapse) And neurovascular involvement:
* Either Ischemic stroke (including TIA) in the vertebro-basilar or carotid territory (symptomatic arterial involvement)
* Either PET uptake of vertebral and/or carotid arteries (extra or intra cranial) and/or angioCT or angioMRI showing arterial involvement consistent with vasculitis (asymptomatic arterial involvement)
* Inclusion should be done
* within 4 weeks after the stroke concerning the "symptomatic" patients
* within 4 weeks after the diagnosis of GCA (or relapse) concerning the patients with asymptomatic neurovascular involvement.
* Within 21 days after starting the corticosteroids
* Signed Informed Consent Form
* Affiliation to social security

Exclusion Criteria:

* Other proven cause of stroke: atrial fibrillation, significant atheromatous stenosis of carotid or vertebro-basilar arteries
* Contraindication to and precaution in use of tocilizumab:

  * Treatment with any investigational agent within 12 weeks (or 5 half-lives of the investigational drug, whichever was longer) of screening
  * Previous treatment with cell-depleting therapies, including investigational agents,including but not limited to Campath (alemtuzumab), anti-CD4, anti-CD5, anti-CD3, anti-CD19, and anti-CD20 within 6 months before the baseline
  * Treatment with IV gamma globulin or plasmapheresis within 24 weeks of baseline
  * Previous treatment with alkylating agents, such as chlorambucil, or with total lymphoid irradiation within 2 months before the baseline
  * Previous treatment with TCZ within 6 months before the baseline
  * Immunization with a live/attenuated vaccine within 4 weeks prior to baseline or simultaneously with tocilizumab treatment
  * Treatment with hydroxychloroquine, cyclosporine A, azathioprine, or mycophenolate mofetil (MMF) within 4 weeks of baseline
  * Treatment with etanercept within 2 weeks; infliximab, certolizumab, golimumab,abatacept, or adalimumab within 8 weeks; or anakinra within 1 week of baseline
  * Previous treatment with tofacitinib within 2 months before the baseline
  * Treatment with cyclophosphamide within 24 weeks of baseline
  * History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies or to prednisone
  * Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary (including obstructive pulmonary disease), renal, hepatic, endocrine (including uncontrolled diabetes mellitus), psychiatric, osteoporosis/osteomalacia, glaucoma, corneal ulcers/injuries, or gastrointestinal disease
  * Current liver disease, as determined by the investigator
  * History of diverticulitis, diverticulosis requiring antibiotic treatment, or chronic ulcerative lower GI disease such as Crohn's disease, ulcerative colitis, or other symptomatic lower GI conditions that might predispose a patient to perforations
  * Known active current or history of recurrent bacterial, viral, fungal, mycobacterial, or other infections (including but not limited to tuberculosis \[TB\] and atypical mycobacterial disease, hepatitis B and C, and herpes zoster, but excluding fungal infections of the nail beds)
  * Any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks of screening
  * Active TB requiring treatment within the previous 3 years
  * Patients treated for TB with no recurrence within 3 years and patients treated for latent TB within 3 years were eligible.
  * Primary or secondary immunodeficiency (history of or currently active)
  * Evidence of malignant disease or malignancies diagnosed within the previous 5 years (except basal and squamous cell carcinoma of the skin or carcinoma in situ of the cervix uteri that had been excised and cured)
  * History of alcohol, drug, or chemical abuse within 1 year prior to screening
  * Body weight \>150 kg
  * Serum creatinine \>1.4 mg/dL (124 µmol/L) in female patients and 1.6 mg/dL (141 µmol/L) in male patients
  * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST)× 3 Upper limit of normal (ULN)\>
  * Platelet count \< 100 109/L (100,000/mm3)
  * Hemoglobin \< 85 g/L (8.5 g/dL; 5.3 mmol/L)
  * White blood cells \<3.0 x109/L (3000/mm3)
  * Absolute neutrophil count \< 2.0 x 109/L (2000/mm3)
  * Absolute lymphocyte count \< 0.5 X 109/L (500/mm3)
  * Positive hepatitis B surface antigen or hepatitis C antibody
  * Contraindication to aspirin, clopidogrel, steroids use, rifampicin and/or isoniazid
  * Major surgery within 8 weeks prior to screening or planned major surgery within 12 months after randomization, except arterial thrombectomy if necessary for ischemic stroke
  * Transplanted organs (except corneal transplant performed more than 3 months prior to screening)
  * Inability to provide informed consent
  * Participation in another interventional research

• Paris, France