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

A Phase II/III, Multicenter, Randomized, Double-blind, Placebo-controlled Study To Assess The Efficacy And Safety Of Tocilizumab Versus Placebo In Patients With Systemic Sclerosis

This multicenter, randomized, double-blind, placebo-controlled, two-arm, parallel-group study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in participants with systemic sclerosis. Participants will be randomized to receive either RoActemra/Actemra 162 mg subcutaneously weekly or placebo for 48 weeks. From Week 48 to Week 96, all participants will receive open-label RoActemra/Actemra 162 mg subcutaneously weekly. Anticipated time on study treatment is 96 weeks.

Inclusion Criteria:

• Adult patients, >/= 18 years of age
• Systemic sclerosis, as defined by American College of Rheumatology (1980) criteria
• Disease duration of </= 60 months (defined as time from first non-Raynaud phenomenon manifestation)
• >/= 15 and </= 40 mRSS units at screening
• Active disease, as defined by protocol
• Uninvolved skin at injection sites
• Negative pregnancy test for a female subject of childbearing potential

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