A Study of the Efficacy and Safety of Tocilizumab in Participants With Systemic Sclerosis (SSc)

Inclusion Criteria:

- Diagnosis of SSc according to American College of Rheumatology (ACR) and European
League Against Rheumatism (EULAR) criteria, meeting criteria for active disease and
with total disease duration of less than or equal to (
- mRSS of 10-35 units, inclusive

- Agreement to remain abstinent or use an effective contraceptive method among males and
females with childbearing potential

Exclusion Criteria:

- Pregnant or lactating females

- Major surgery within 8 weeks prior to screening

- Scleroderma limited to the face or areas distal to the elbows or knees

- Rheumatic autoimmune disease other than SSc

- Immunization with a live or attenuated vaccine within 4 weeks prior to Baseline

- Known hypersensitivity to human, humanized, or murine monoclonal antibodies

- Moderately severe nervous system, renal, endocrine, pulmonary, cardiovascular, or
gastrointestinal (GI) disease not related to SSc, including diverticulitis or
ulcerative lower GI disorders, or myocardial infarction (MI) within 6 months prior to
screening

- Active or significant history of infection, including treatment with intravenous (IV)
antibiotics within 4 weeks or oral antibiotics within 2 weeks prior to screening

- Significant history of tuberculosis (TB)

- Primary or secondary immunodeficiency

- Malignant disease, with the exception of excised/cured local basal or squamous cell
carcinoma of the skin or carcinoma in situ of the uterine cervix

- History of drug or alcohol abuse