A Long-Term Extension Study of RoActemra/Actemra (Tocilizumab) in Patients With Juvenile Idiopathic Arthritis Who Completed WA19977 Core Study
Condition: Juvenile Idiopathic Arthritis
MeSH terms: Arthritis; Arthritis, Juvenile
Intervention: tocilizumab [RoActemra/Actemra]
Intervention description: 8 mg/kg iv every 4 weeks, 104 weeks
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 9 Years
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      This long-term, open-label extension study will evaluate the safety of RoActemra/Actemra
      (tocilizumab) in patients with polyarticular-course juvenile idiopathic arthritis who
      completed the WA19977 core study. Patients aged 9-18 years with at least JIA ACR30 clinical
      response to RoActemra/Actemra in the core study will be eligible to receive RoActemra/Actemra
      8 mg/kg intravenously every 4 weeks. Anticipated time on study treatment is 104 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients 9 to 18 years of age who completed visit 33 (week 104) of WA19977 study with
             at least JIA ACR30 clinical response to RoActemra/Actemra relative to baseline in
             WA19977, with no AEs, SAEs or conditions that lead to unacceptable risk of continued
             treatment

          -  Scheduled to receive first RoActemra/Actemra infusion in this study between 4 and 6
             weeks after the last IV infusion in the core study

          -  Females of child-bearing potential and males with female partners of child-bearing
             potential must agree to use effective contraception as defined by protocol

        Exclusion Criteria:

          -  Patients with, according to investigator judgment, not satisfactory benefit from
             RoActemra/Actemra therapy within WA19977

          -  Treatment with any investigational agent since the last administration of study drug
             in the core study WA19977 or current participation in another clinical trial except
             WA19977

          -  Patient developed any other autoimmune rheumatic disease or overlap syndrome other
             than the permitted polyarticular-course JIA subsets: rheumatoid factor positive or
             negative JIA or extended oligoarticular JIA

          -  Patient is pregnant , lactating, or intending to become pregnant during the study and
             up to 12 weeks after the last administration of study drug

          -  Any significant concomitant disease or medical or surgical condition

          -  History of significant allergic or infusion reactions to prior biologic therapy

          -  Known current active acute, subacute, chronic or history of recurrent infection;
             patients suffering from ongoing active infections with Epstein Barr virus, herpes
             zoster or recurrent history of urinary tract infection can be included after the
             (acute) infection has been excluded or subsided

          -  Positive for latent tuberculosis (TB)

          -  Currently active asthma for which the patient has required the use of oral or
             parenteral corticosteroids for >/= 2 weeks within 6 months prior to entering the study

          -  Inadequate hepatic, renal or bone marrow function