NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	sJIA
Date of first enrollment	02/09/2005
Target sample size
Countries of recruitment
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : MRA (tocilizumab) INN of investigational material : Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Investigational material : Intravenous infusion

Outcome(s)

Primary Outcome	[Open label phase] Efficacy: JIA core set improvement. [Double blind phase] Efficacy: The main efficacy endpoint in the double blind withdrawal phase is the portion of patients maintaining JIA core set improvement. Safety: Frequency and severity of adverse events and adverse drug reactions
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 2age old
Age maximum	<= 19age old
Gender
Include criteria	Inclusion criteria 1. Patients with sJIA diagnosed according to the revised 1997 ILAR (the International league of associations for Rheumatology) criteria 2. 2 and over Age and below 20
Exclude criteria