A Study of Subcutaneously (SC) Administered Tocilizumab (TCZ) in Participants With Polyarticular-Course Juvenile Idiopathic Arthritis (pJIA)
Condition: Juvenile Idiopathic Arthritis
MeSH terms: Arthritis; Arthritis, Juvenile
Intervention: Tocilizumab
Intervention description: Participants will receive 162 mg of TCZ as SC injection Q3W or Q2W for 52 weeks
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 1 Year
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      This open-label, multicenter study evaluated the pharmacokinetics, pharmacodynamics and
      safety of SC administered TCZ in participants with pJIA.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ages 1 year (12 years for participants in Russia) up to and including 17 years at
             screening

          -  Diagnosis of pJIA according to International League of Associations for Rheumatology
             classification

          -  Rheumatoid factor (RF)-positive 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)

          -  Participants currently receiving TCZ by the intravenous (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. Participants participating in the study may be either naive
             to TCZ therapy or may be switching from IV to SC. The total number of participants
             switching from IV TCZ must account for no more than 50 percent (%) of the total
             participant number. To account for the baseline TCZ concentrations in these
             participants, information on the last 4 IV TCZ infusions prior to baseline will be
             collected

          -  Concurrent treatment with disease-modifying antirheumatic drugs (DMARDs) (including
             MTX), nonsteroidal anti-inflammatory drugs (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)

          -  Participants with poorly controlled disease (in the opinion of the treating physician)
             despite current treatment with IV TCZ

          -  pJIA that is well controlled by any treatment agent other than TCZ (Juvenile Arthritis
             Disease Activity Score 71 [JADAS-71] less than or equal to (< / =) 3.8)

          -  Participants 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
             participant's safety or ability to complete the study

          -  Known human immunodeficiency virus (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 purified protein derivative (PPD) at screen, unless treated with anti-TB
             therapy for at least 4 weeks prior to receiving study drug and chest radiograph is
             negative for active TB within 6 months of screening visit according to local practice

          -  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

          -  Prior stem cell transplant at any time