A Study of Subcutaneously Administered RoActemra/Actemra (Tocilizumab) in Patients With Polyarticular-Course Juvenile Idiopathic Arthritis

Inclusion Criteria:

- Ages 1 year up to and including 17 years at screening

- Diagnosis of polyarticular-course juvenile idiopathic arthritis according to
International League of Associations for Rheumatology classification

- Rheumatoid factor (RF)-positive polyarticular JIA (pJIA)

- RF-negative pJIA

- Extended oligoarticular JIA with a polyarticular course

- History of inadequate clinical response (in the opinion of the treating physician) to
or inability to tolerate methotrexate (MTX)

- If a patient has received previous treatment with any biologic agents other than TCZ
(tocilizumab), these must have been discontinued according to the timelines defined
by protocol prior to the baseline visit

- Patients currently receiving TCZ by the IV route of administration and with
well-controlled disease do not require a period of discontinuation of IV TCZ and
should have their first dose of SC TCZ administered on the date that their next IV
TCZ infusion would be due.

- Concurrent treatment with DMARDs (including MTX), NSAIDs, and oral corticosteroids
are permitted at the discretion of the investigator.

- Females of childbearing potential and non-sterile males with female partner of
childbearing potential must agree to use effective contraception as defined by
protocol

Exclusion Criteria:

- Prior discontinuation of IV TCZ because of inadequate clinical response or safety
events (including hypersensitivity)

- Patients with poorly controlled disease (in the opinion of the treating physician)
despite current treatment with IV TCZ

- pcJIA that is well controlled by any treatment agent other than TCZ (Juvenile
Arthritis Disease Activity Score [JADAS]-71 < / = 3.8)

- Patients who are wheelchair-bound or bedridden

- Any other auto-immune, rheumatic disease, or overlapping syndrome other than the
permitted pcJIA subsets

- Lack of recovery from recent surgery or an interval of < 6 weeks since surgery at the
time of the screening visit

- Females who are pregnant, lactating, or intending to become pregnant during study
conduct

- Any significant concurrent medical or surgical condition that would jeopardize the
patient's safety or ability to complete the study

- Known HIV infection or other acquired forms of immune compromise or inborn conditions
characterized by a compromised immune system

- History of alcohol, drug, or chemical abuse within 6 months of screening

- Any active acute, subacute, chronic, or recurrent bacterial, viral, or systemic
fungal infection or any major episode of infection requiring hospitalization or
treatment during screening or treatment with IV antibiotics completed within 4 weeks
of the screening visit or oral antibiotics completed within 2 weeks of the screening
visit

- History of atypical tuberculosis (TB) or active TB requiring treatment within 2 years
prior to screening visit

- Positive TB test at screening unless treated with anti-TB therapy for at least 4
weeks prior to receiving study drug

- History of reactivation or new onset of a systemic infection such as herpes zoster or
Epstein-Barr virus within 2 months of the screening visit

- Hepatitis B surface antigen or hepatitis C antibody positivity or chronic viral or
autoimmune hepatitis

- History of concurrent serious gastrointestinal disorders such as ulcer or
inflammatory bowel disease, Crohn's disease, ulcerative colitis, or other symptomatic
lower gastrointestinal conditions

- History of or current cancer or lymphoma

- Uncontrolled diabetes mellitus with elevated glycosylated hemoglobin

- Active uveitis at screening

- Inadequate hematologic, renal or liver function