A Study of Decreased Dose Frequency in Participants With Systemic Juvenile Arthritis Who Experience Laboratory Abnormalities During Treatment With RoActemra/Actemra (Tocilizumab)

Inclusion Criteria:

PART 1 and 2

- Children 2 to 17 years of age inclusive at screening

- Systemic juvenile idiopathic arthritis (sJIA) according to International League of
Associations for Rheumatology (ILAR) classification (2001) and sJIA symptoms lasting
for at least 1 month since diagnosis of sJIA

- Must meet one of the following:

- Not receiving methotrexate (MTX) or discontinued MTX at least 4 weeks prior to
baseline visit, or

- Taking MTX for at least 12 weeks immediately prior to the baseline visit and on a
stable dose of less than or equals ( at least 8 weeks prior to the baseline visit, together with either folic acid or
folinic acid according to local standard of care

- Participants entering Part 1 who are naive to TCZ therapy must also meet the following
inclusion criterion:

- History of inadequate clinical response (in the opinion of the treating physician) to
Non steroidal Anti-Inflammatory Drugs (NSAIDs) and corticosteroids PART 2

- Juvenile Arthritis Disease Activity Score (JADAS) -71 score of 3.8 or less and absence
of fever (related to sJIA) at screening and baseline

- Neutropenia, thrombocytopenia, or elevated Alanine transaminase/Aspartate transaminase
(ALT/AST) previously experienced on the labeled dose (Q2W) of RoActemra/Actemra at any
time

- Not currently receiving oral corticosteroids, or taking oral corticosteroids at a
stable dose for a minimum of 2 weeks prior to baseline visit at no more than 10
milligrams per day (mg/day) or 0.2 miiligrams per kilogram per day (mg/kg/day),
whichever is less

- Not taking (NSAIDs), or taking no more than 1 type of NSAID at a stable dose for a
minimum of 2 weeks prior to the baseline visit, with the dose being less than or equal
to the maximum recommended daily dose

Exclusion Criteria:

- Wheelchair bound or bedridden

- Any other auto-immune, rheumatic disease, or overlap syndrome other than sJIA

- Pregnant or lactating, or intending to become pregnant during study conduct and up to
6 months after the last administration of study drug

- Any significant concurrent medical or surgical condition which would jeopardize the
participant's safety or ability to complete the trial

- History of significant allergic or infusion reactions to prior TCZ infusion, and/or
presence of anti-TCZ antibodies at screening

- Inborn conditions characterized by a compromised immune system

- Known Human Immunodeficiency Virus (HIV) infection or other acquired forms of immune
compromise

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

- Evidence of serious uncontrolled concomitant diseases, including but not limited to
the nervous, renal, hepatic, or endocrine systems

- Any active acute, subacute, chronic or recurrent bacterial, viral, or systemic fungal
infection

- History of atypical tuberculosis (TB)

- Active TB requiring treatment within 2 years prior to the screening visit

- Positive purified protein derivative (PPD) at screening

- Any major episode of infection requiring hospitalization or treatment during screening
or treatment with IV antibiotics completing within 4 weeks of the screening visit or
oral antibiotics completing within 2 weeks of the screening visit

- History of reactivation or new onset of a systemic infection within 2 months of the
screening visit

- Positive for hepatitis B or hepatitis C infection

- Chronic hepatitis, viral or pulmonary disease

- Significant cardiac or pulmonary disease

- History of or current cancer or lymphoma

- Uncontrolled diabetes mellitus

- History of or concurrent serious gastrointestinal disorders

- History of macrophage activation syndrome (MAS) within 3 months prior to screening
visit