Tocilizumab for Patients With Giant Cell Arteritis

• Patients with newly onset or relapsed GCA
• > 50 years of age
• satisfying ACR criteria
• elevated sedimentation rate above 40 mm
• CRP > 20 mg/L
• Patients with histologically proven GCA or with large vessel vasculitis assessed by MRI

Exclusion Criteria

• Rheumatic diseases (except for CPPD/chondrocalcinosis) other than GCA/Takayasu disease or polymyalgia rheumatica (i.e., RA, autoimmune connectivitides, other systemic vasculitides, a.o.)
• Evidence of significant and/or uncontrolled concomitant disease
• Diagnosis of GCA > 4 weeks before screening visit and beginning of GC treatment > 4 weeks before screening (only valid for new onset GCA), or when a patient received treatment with tocilizumab or with other biological agents (such as TNFα-blockers) within 3 months before screening
• Any condition or general state of health which, in the Investigator's opinion, would preclude participation in the study
• Actual or recent myocardial infarction (within the last 3 months before screening visit)
• Significant cardiac disease (NYHA Class III and IV), known severe chronic obstructive pulmonary disease (COPD) (FEV1 \< 50% predicted or Functional dyspnoea > Grade 3 on the MRC Dyspnoea Scale) or other significant pulmonary disease
• Uncontrolled disease (such as asthma, psoriasis or inflammatory bowel disease) where flares are commonly treated with oral or injectable corticosteroids
• Known active infection of any kind, or any major episode of infection requiring hospitalization or treatment with i.v. anti-infectives within 4 weeks of baseline or completion of oral anti-infectives within 2 weeks prior to baseline
• History of deep space/tissue infection (e.g. fasciitis, abscess, osteomyelitis) within 52 weeks prior to baseline
• Any surgical procedure, including bone/joint surgery within 8 weeks prior to baseline or planned within the duration of the study
• History of serious recurrent or chronic infection (for screening for a chest infection a chest radiograph will be performed at screening if not performed within 12 weeks prior to screening)
• Lack of peripheral venous access
• Body weight > 150 kg or BMI > 35
• Previous treatment with tocilizumab or any other biological agent
• Treatment with any investigational agent within 28 days of screening or 5 half-lives of the investigational drug (whichever is the longer)
• History of severe allergic or anaphylactic reaction to any biologic agent or known hypersensitivity to any component of tocilizumab (RoActemra)
• Receipt of any vaccine within 28 days prior to baseline (a patient's vaccination record and need for immunization prior to receiving tocilizumab/placebo must be carefully investigated)
• Positive tests for hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (HbcAb) or hepatitis C serology
• Positive Quantiferon-TB® test for latent Tb without subsequent INH prophylaxis
• Patients with active Tb which had to be treated for Tb within 2 years before the screening visit