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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail

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Approval Date:  02/21/2008
 
Trade Name:  Humira
 
Generic or Proper Name (*):  adalimumab
 
Indications Studied:  Treatment of juvenile idiopathic arthritis
 
Therapeutic Category:  Anti-inflammatory
 
Ages Studied:  4 years and older
 
Study #:  1
 
Study Type:  Efficacy/Safety/Pharmacokinetic
 
Study Design:  Open Label/Blind/Placebo/Parallel Group/Population Pharmacokinetic
 
No Patients:  171
 
No Centers:  31
 
No Countries:  8
 
BPCA(B), PREA(P):  P
 
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