An Efficacy and Safety Study of Tocilizumab (RoActemra/Actemra) in Participants With Giant Cell Arteritis (GCA)

Inclusion Criteria:

- Diagnosis of GCA classified according to age >/=50 years; history of ESR >/=50 mm/hr
or history of CRP >/=2.45 mg/dL; and at least one of the following: unequivocal
cranial symptoms of GCA or symptoms of polymyalgia rheumatica [PMR]; and at least one
of the following: temporal artery biopsy revealing features of GCA or evidence of
large-vessel vasculitis by angiography or cross-sectional imaging

- New onset (diagnosis within 6 weeks of baseline) or refractory (diagnosis greater than
[>] 6 weeks before baseline and previous treatment with >/= 40 milligrams per day
prednisone [or equivalent] for at least 2 consecutive weeks at any time) GCA

- Active disease (presence of clinical signs and symptoms [cranial or PMR] and ESR >/=30
mm/hour or CRP >/=1 mg/dL) within 6 weeks of baseline visit

Exclusion Criteria:

- Major surgery within 8 weeks prior to screening or planned within 12 months after
randomization

- Transplanted organs (except corneas with transplant performed >3 months prior to
screening)

- Major ischemic event, unrelated to GCA, within 12 weeks of screening

- Prior treatment with any of the following: investigational agent within 12 weeks (or 5
half-lives of the investigational drug, whichever is longer) of screening;
cell-depleting therapies including investigational agent; intravenous (IV) gamma
globulin or plasmapheresis within 6 months of baseline; alkylating agents or with
total lymphoid irradiation; tocilizumab; hydroxychloroquine, cyclosporine A,
azathioprine, or mycophenolate mofetil within 4 weeks of baseline; etanercept within 2
weeks of baseline; infliximab, certolizumab, golimumab, abatacept, or adalimumab
within 8 weeks of baseline; anakinra within 1 week of baseline; tofacitinib;
cyclophosphamide within 6 months of baseline; >100 milligrams of daily IV
methylprednisolone within 6 weeks of baseline

- Participants requiring systemic glucocorticoids for conditions other than GCA, which,
in the opinion of the investigator, would interfere with adherence to the fixed
glucocorticoid taper regimen and/or to assessment of efficacy in response to the test
article

- History of severe allergic reactions to monoclonal antibodies or to prednisone

- Evidence of serious uncontrolled concomitant disease (for example, cardiovascular,
respiratory, renal, endocrine, psychiatric, corneal ulcers/injuries, or
gastrointestinal [GI] disease)

- Current liver disease, as determined by the investigator

- History of diverticulitis, inflammatory bowel disease, or other symptomatic GI tract
condition that might predispose to bowel perforation

- Known active or history of recurrent bacterial, viral fungal, mycobacterial, or other
infection

- Primary or secondary immunodeficiency

- Evidence of malignancies diagnosed within previous 5 years (except basal and squamous
cell carcinoma of the skin or carcinoma in situ of the cervix uteri that have been
excised and cured)

- Inadequate hematologic, renal or liver function

- Positive for hepatitis B or hepatitis C infection