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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  04/15/2011
 
Trade Name:  Actemra
 
Generic or Proper Name (*):  tocilizumab
 
Indications Studied:  Treatment of active Systemic Juvenile Idiopathic Arthritis (SJIA)
 
Therapeutic Category:  Biological response modifier
 
Study #:  1
 
Study Type:  Efficacy/Safety
 
Study Design:  Blind/Placebo/Parallel Group
 
No Patients:  112
 
No Centers:  43
 
No Countries:  17
 
BPCA(B), PREA(P):  P
 
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