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About
This is a multi-center, open-label single-arm study to investigate the pharmacokinetics and safety of tocilizumab (RoActemra/Actemra) in participants less than 2 years old with active sJIA. Participants will receive tocilizumab infusions every 2 weeks. The anticipated time on study treatment is 12 weeks (Main evaluation period). Participants will have the option to continue tocilizumab treatment until participant reaches 2 years of age or up to one year from baseline, whichever is longer. An optional extension period will follow the main evaluation period.
Enrollment
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Inclusion criteria
Fulfils international league of associations for rheumatology (ILAR) classification criteria for sJIA
Duration of sJIA symptoms lasting for at least 1 months subsequent to diagnosis of sJIA
Presence of active disease as determined by the presence of:
Not currently receiving corticosteroids (CS) or if taking oral CS like prednisone or equivalent, the dose should be less than or equal to (<=) 1 milligram per kilogram per day (mg/kg/day) and the dose has remained stable for at least 2 weeks prior to baseline
Not currently receiving methotrexate (MTX) or if taking MTX (together with either folic acid or folinic acid according to local standard-of-care), the dose has remained stable or has been discontinued for at least 4 weeks prior to baseline
Not currently receiving non-steroidal anti-inflammatory drugs (NSAIDs) or if taking NSAID, the dose has remained stable or has been discontinued for at least 2 weeks prior to baseline
If the participants has received previous treatment with any of the following biologic agents, these must have been discontinued according to the following timelines prior to the baseline visit and are not permitted during the study:
History of inadequate clinical response (in the opinion of the treating physician) to NSAIDs and CS
Exclusion criteria
General Exclusion Criteria:
General Safety Exclusion Criteria:
Excluded Previous or Concomitant Therapy:
Primary purpose
Allocation
Interventional model
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11 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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