Clinical Trial: Clinical Study of TA-650 in Pediatric Patients With Ulcerative Colitis
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 Ulcerative Colitis.
Brief Summary: The purpose of this study is to evaluate the the efficacy of TA-650 using Clinical activity index (CAI) score and other evaluation indicators in pediatric patients with moderate to severe ulcerative colitis after TA-650 administration of at a dose of 5 mg/kg at weeks 0, 2, and 6, and then every 8 weeks at weeks 14 and 22. 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 remission as defined by CAI score ≦4 [ Time Frame: Baseline (Week 0) and Weeks 2, 6, 8, 10, 14, 18, 22, 26, and 30 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- CAI score at Weeks 0, 2, 6, 8, 10, 14, 18, 22, 26, and 30 [ Time Frame: Baseline (Week 0) and Weeks 2, 6, 8, 10, 14, 18, 22, 26, and 30 ]
- partial Mayo score at Weeks 0, 2, 6, 8, 10, 14, 18, 22, 26, and 30 [ Time Frame: Baseline (Week 0) and Weeks 2, 6, 8, 10, 14, 18, 22, 26, and 30 ]
- Pediatric ulcerative colitis activity index (PUCAI) score at Weeks 0, 2, 6, 8, 10, 14, 18, 22, 26, and 30 [ Time Frame: Baseline (Week 0) and Weeks 2, 6, 8, 10, 14, 18, 22, 26, and 30 ]
Original Secondary Outcome: Same as current
Information By: Mitsubishi Tanabe Pharma Corporation
Dates:
Date Received: April 24, 2012
Date Started: February 2012
Date Completion:
Last Updated: May 10, 2015
Last Verified: May 2015
