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Phase III trial of tocilizumab for systemic juvenile idiopathic arthritis in Japan.
A phase III trial consisted of three phases: an open-label lead-in phase of 6 weeks (OPEN); a double-blind, randomized, placebo-controlled phase of 12 weeks (BLIND); and an open-label extension phase of at least 48 weeks (EXTENSION).The double-blind part was designed as a withdrawal study after the first 6 weeks of being in a lead-in phase [Yokota et al. 2008].
