A PHASE IV STUDY TO EVALUATE DECREASED DOSE FREQUENCY IN PATIENTS WITH SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (SJIA) WHO EXPERIENCE LABORATORY ABNORMALITIES DURING TREATMENT WITH TOCILIZUMAB

F. Hoffmann-La Roche Ltd.0 个研究点目标入组 35 人开始时间: 2012年9月27日最近更新: 2020年5月11日

试验速览

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•Age 2 years up to and including 17 years at screening into trial
•sJIA according to International League of Associations for Rheumatology (ILAR) classification (2001)
•JADAS-71 score of 3.8 or less and absence of fever (related to sJIA) at screening and baseline (Consolaro et al. 2012)
•Neutropenia, thrombocytopenia, or elevated ALT/AST (as per defined criteria) previously experienced (and resolved) on the labeled dose (Q2W) of TCZ at any time
•Must meet one of the following:
•Not receiving MTX or discontinued MTX at least 4 weeks prior to baseline visit, or
•Taking MTX for at least 12 weeks immediately prior to the baseline visit and on a stable dose of =20 mg/m2 for at least 8 weeks prior to the baseline visit, together with either folic acid or folinic acid according to local standard of care
•Not currently receiving oral corticosteroids, or taking oral corticosteroids at a stable dose for a minimum of 2 weeks prior to the baseline visit at no more than 10 mg/day or 0.2 mg/kg/day, whichever is less
•Not taking NSAIDs, or taking no more than 1 type of NSAID at a stable dose for a minimum of 2 weeks prior to the baseline visit, with the dose being less than or equal to the maximum recommended daily dose
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 20
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Any other auto-immune, rheumatic disease, or overlap syndrome other than sJIA
•Any significant concurrent medical or surgical condition which would jeopardize the patient’s safety or ability to complete the trial
•Pregnant, lactating, or intending to become pregnant during study conduct and up to 12 weeks after the last administration of study drug
•History of significant allergic or infusion reactions to prior TCZ infusion, and/or presence of anti-TCZ antibodies by confirmatory and/or neutralizing assay at screening
•Any active acute, subacute, chronic, or recurrent bacterial, viral, or systemic fungal infection including but not limited to:
•a) Acute or chronic renal / bladder infections
•b) Acute or chronic pulmonary infections
•Significant cardiac [e.g., congenital heart disease, valvular heart disease, constrictive pericarditis (unrelated to sJIA), myocarditis] or pulmonary disease, (e.g., asthma for which the patient has required the use of oral or parenteral corticosteroids for = 2 weeks within 6 months prior to the baseline visit, cystic fibrosis)
•History of or current cancer or lymphoma
•History of MAS within 3 months prior to the screening visit

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