a study of tocilizumab in chinese participants with systemic juvenile idiopathic arthritis (sjia)

Conditions: Juvenile Idiopathic Arthritis

Summary: this phase iv, multicenter, single-arm, open-label study will evaluate the efficacy and safety of tocilizumab in chinese participants with sjia with persistent activity and an inadequate response to non-steroidal anti-inflammatory drugs (nsaids) and steroid therapy.


Eligibility criteria:
inclusion criteria: * participants meeting international league of associations for rheumatology (ilar) classification for sjia * greater than (\>) 6 months of documented persistent sjia activity prior to screening * active disease * hscrp \>4.3 milligrams per liter (mg/l) or 0.43 milligrams per deciliter (mg/dl) * participant who has recovered from any symptomatic serositis for at least 30 days prior to the screening visit, and requires a dose of css at baseline of \</=30 mg/day or \</=0.5 mg/kg/day, whichever is less * participants meeting one of the following: participant who is not receiving mtx or discontinued mtx \>/=4 weeks prior to baseline visit; participant who has been taking mtx \>/=12 weeks immediately prior to the baseline visit and on a stable dose of \ /=8 weeks prior to the baseline visit, together with either folic acid or folinic acid according to local standard of care * participant who was never treated with biologics or, if was previously treated with biologics, discontinued etanercept (or yisaipu, qiangke, or anbainuo) \>/=2 weeks, infliximab or adalimumab \>/=8 weeks, anakinra \>/=1 week, or abatacept \>/=12 weeks prior to the baseline visit * participant who is not currently receiving oral css, or is taking oral css at a stable dose for \>/=2 weeks prior to the baseline visit at \</=30 mg/day or \</=0.5 mg/kg/day, whichever is less * participant who is not taking nsaids, or taking \ /=2 weeks prior to the baseline visit and is less than or equal to the maximum recommended daily dose exclusion criteria: * wheelchair bound or bedridden participant * any other autoimmune, rheumatic disease, or overlap syndrome other than sjia * participant who is not fully recovered from recent surgery or \<6 weeks since surgery at the time of screening visit; or planned surgery during the initial 12 weeks of the study * lack of peripheral venous access * any significant concurrent medical or surgical condition that would jeopardize the participant's safety or ability to complete the trial * evidence of serious uncontrolled concomitant diseases * asthma for which the participant has required the use of oral or parenteral css for \>/=2 weeks within 6 months prior to the baseline visit * known human immunodeficiency (hiv) infection or other acquired forms of immune compromise or congenital conditions characterized by a compromised immune system * any active acute, subacute, chronic, or recurrent bacterial, mycobacterial, viral, or systemic fungal infection or opportunistic infection * any major episode of infection requiring hospitalization or treatment during screening, 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 atypical tuberculosis (tb) * active tb requiring treatment within 2 years prior to screening visit * positive purified protein derivative (ppd) or t-spot test (interferon-gamma \[ifn-γ\]-based test) at screen * positive for latent tb * history of reactivation or new onset of a systemic infection such as herpes zoster or epstein-barr virus (ebv) within 2 months of the screening visit * hepatitis b surface antigen (ag)- or hepatitis c antibody (ab)-positive * history of macrophage activation syndrome (mas) within 3 months prior to the screening visit * evidence of active malignant disease or diagnosed malignancies * uncontrolled diabetes mellitus * previous treatment with tocilizumab * intra-articular, intramuscular, iv, or long-acting css administration within 28 days prior to the baseline visit * treatment with non-biologic disease-modifying antirheumatic drugs (dmards; other than mtx) within 6 weeks prior to the baseline visit * treatment with leflunomide that was not followed by standardized cholestyramine washout and documented to be below the limit of detection prior to the baseline visit * treatment with cyclophosphamide, etoposide (vp16) and statins within 90 days prior to the baseline visit * treatment with growth hormone and androgens within 4 weeks prior to the baseline visit * administration of iv immunoglobulin within 28 days prior to the baseline visit * treatment with any cell-depleting therapies * stem cell transplant at any time * participant who has received live or attenuated vaccines within 4 weeks prior to the baseline visit, or intending to receive while on study drug or 3 months following the last dose of study drug