A Study of RoActemra/Actemra (Tocilizumab) Versus Placebo in Patients With Systemic Sclerosis

Exclusion Criteria

• •Major surgery (including joint surgery) within 8 weeks prior to and/or during study enrollment
• •Rheumatic autoimmune disease other than systemic sclerosis
• •Skin thickening (scleroderma) limited to areas distal to the elbows or knees at screening
• •Previous treatment with tocilizumab
• •History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies
• •Severe cardiopulmonary disease
• •Known active current or history of recurrent infections
• •Use of any investigational, biologic, or immunosuppressive therapies including intra-articular or parenteral corticosteroids prior to study enrollment as specified in the protocol
• •As specified in the protocol, any current or past medical condition or medical history involving but not limited to the nervous, renal, pulmonary, endocrine, and gastrointestinal organ systems determined by the Principal Investigator to pose a significant safety risk to any subject while participating in the study
• •Primary or secondary immunodeficiency