Sponsor study identifier
interventional
21
1 country
7
Study Start
February 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2014
Actual (reported)Study Completion
September 2014
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2014
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2012
Date type not reportedThis date has not been verified as actual or estimated.
April 24, 2012
Actual (reported)April 25, 2012
Actual (reported)September 2014
Actual (reported)September 2014
Actual (reported)October 21, 2019
Actual (reported)Percent of Patients Who Achieved CAI Remission
Clinical activity index (CAI) remission was defined as a case where a CAI score was not more than 4 on the evaluation day. CAI score was an activity index to evaluate disease activity, which is calculated as the sum (0 to 29 points) of subscores for 7 clinical conditions, consisting of the number of stools per week, blood in stools (based on weekly average), investigator's global assessment of the symptomatic state, abdominal pain/cramps, temperature elevation due to ulcerative colitis, extraintestinal manifestations, and laboratory findings (hemoglobin or ESR). A higher score indicates greater disease activity.
Weeks 2, 6, 8, 10, 14, 18, 22, 26, 30, and the last time point during the period from administration of the study drug to Week 30
CAI Score
Baseline,Weeks 2, 6, 8, 10, 14, 18, 22, 26, 30, and the last time point during the period from administration of the study drug to Week 30
Partial Mayo Score
Baseline,Weeks 2, 6, 8, 10, 14, 18, 22, 26, 30, and the last time point during the period from administration of the study drug to Week 30
Pediatric Ulcerative Colitis Activity Index (PUCAI) Score
Baseline,Weeks 2, 6, 8, 10, 14, 18, 22, 26, 30, and the last time point during the period from administration of the study drug to Week 30
TA-650 will be intravenously infused at 5 mg/kg as an induction regimen at Weeks 0, 2, 6. For subjects who meet the responder criteria, TA-650 will be administered at 8-week intervals thereafter until week 22.
Investigational site
Chūbu, Japan
Investigational site
Hokkaido, Japan
Investigational site
Hokuriku, Japan
Investigational site
Kanto, Japan
Investigational site
Kinki, Japan
Investigational site
Kyusyu, Japan
Investigational site
Tōhoku, Japan
Tajiri H, Arai K, Kagimoto S, Kunisaki R, Hida N, Sato N, Yamada H, Nagano M, Susuta Y, Ozaki K, Kondo K, Hibi T. Infliximab for pediatric patients with ulcerative colitis: a phase 3, open-label, uncontrolled, multicenter trial in Japan. BMC Pediatr. 2019 Oct 13;19(1):351. doi: 10.1186/s12887-019-1739-5.
Toshifumi Hibi, MD
Kitasato University Kitasato Institute Hospital
Kazuoki Kondo, MD
Mitsubihsi Tanabe Pharma Corporation
21 participants (actual enrollment reported by the registry).
First Submitted
April 24, 2012
First Posted
April 25, 2012
Study Start
February 2012
Date type not reportedThis date has not been verified as actual or estimated.
Mission is Remission®: How Can a Disease Self-management Website Change Care?
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Primary Completion
September 2014
Actual (reported)Study Completion
September 2014
Actual (reported)Last Updated
January 7, 2026
Results First Posted
October 21, 2019
Record last verified: 2025-12
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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