Clinical Trial: Clinical Study of TA-650 in Pediatric Patients With Crohn's Disease
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of TA-650 in Pediatric Patients With Moderate to Severe Crohn's Disease
Brief Summary: The purpose of this study is to evaluate the efficacy of TA-650 using Pediatric Crohn's Disease Activity Index (PCDAI) and other evaluation indicators in pediatric patients with moderate to severe Crohn's disease after TA-650 administration at a dose of 5 mg/kg at weeks 0, 2, and 6, then every 8 weeks 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.
Detailed Summary:
Sponsor: Mitsubishi Tanabe Pharma Corporation
Current Primary Outcome: Change from baseline of percent of participants with clinical response as defined by a decrease of PCDAI score of at least 15 points with a total score of no more than 30 points [ Time Frame: Baseline(Week 0) and Weeks 2, 6, 10, 14, 18, 22, 26, 30, 34, 38, 42, 46, 50, and 54 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- PCDAI at Weeks 0, 2, 6, 10, 14, 18, 22, 26, 30, 34, 38, 42, 46, 50, and 54 [ Time Frame: Baseline(Week 0) and Weeks 2, 6, 10, 14, 18, 22, 26, 30, 34, 38, 42, 46, 50, and 54 ]
- Change from baseline in percent of participants with clinical remission as defined by PCDAI score ≦ 10 [ Time Frame: Baseline(Week 0) and Weeks 2, 6, 10, 14, 18, 22, 26, 30, 34, 38, 42, 46, 50, and 54 ]
Original Secondary Outcome: Same as current
Information By: Mitsubishi Tanabe Pharma Corporation
Dates:
Date Received: April 3, 2012
Date Started: March 2012
Date Completion:
Last Updated: April 9, 2015
Last Verified: April 2015
