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Clinical Trial Summary

The purpose of this study is to evaluate the efficacy of TA-650 using Pediatric Crohn's Disease Activity Index (PCDAI) in pediatric patients with moderate to severe Crohn's disease after TA-650 administration at a dose of 5 mg/kg at week 0, 2, and 6, then every 8 week after week 14 up to week 46, and at a dose of 10 mg/kg if the effect is attenuated. The safety and pharmacokinetics are also evaluated.


Clinical Trial Description

This is an open-label, uncontrolled, multicenter Phase 3 study conducted in Japan. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01580670
Study type Interventional
Source Mitsubishi Tanabe Pharma Corporation
Contact
Status Completed
Phase Phase 3
Start date March 2012
Completion date March 2015

See also
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