Tocilizumab for Patients With Giant Cell Arteritis

This is an interventional treatment trial for Giant Cell Arteritis focused on measuring Giant Cell Arteritis, Tocilizumab, Antibodies, Monoclonal, Glucocorticoids Read More

Inclusion Criteria:

• 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