Skip to main content
OpenTrials
Completed

NCT Number: NCT01585155

Clinical Study of TA-650 in Pediatric Patients With Ulcerative Colitis

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pediatric Ulcerative Colitis

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigational site, Chūbu, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who have been diagnosed as ulcerative colitis at least 3 months prior to screening.
  • Have active ulcerative colitis despite adequate conventional therapy.

Exclusion criteria

  • Patients who have severe pancolitis.
  • Patients who have undergone surgery for ulcerative colitis within 8 weeks before enrollment or who were judged to require surgery for ulcerative colitis at enrollment.
  • Patients who have a history of treatment with infliximab or other biologic products (anti-TNFα agents, anti-IL-6 agents, etc.).

Treatment and study plan

TA-650

Drug

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.

Primary outcomes

  1. Percent of Patients Who Achieved CAI Remission

    Time frame: 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

    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.

Secondary outcomes

  1. CAI Score

    Time frame: 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

    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.

  2. Partial Mayo Score

    Time frame: 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

    Mayo score consists of four subscores (stool frequency, rectal bleeding, physician's global assessment and findings of endoscopy), each of which was assessed according to a four-level rating scale (0 to 3 points), and was determined from a total of the four subscores (0 to 12 points). In addition, the sum of the subscores (0 to 9 points) for stool frequency, rectal bleeding and physician's global assessment was used as a partial Mayo score. A higher score indicates greater disease activity.

  3. Pediatric Ulcerative Colitis Activity Index (PUCAI) Score

    Time frame: 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

    PUCAI score was determined as a total of the subscores for each of the six evaluation items (0 to 85), including abdominal pain, rectal bleeding, stool consistency of most stools, number of stools per 24 hours, nocturnal stools and activity level. A higher score indicates greater disease activity.

Sponsors and collaborators

Lead sponsor

Tanabe Pharma Corporation

Industry

Registry information

Official study title

Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of TA-650 in Pediatric Patients With Moderate to Severe Ulcerative Colitis.

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Apr 25, 2012
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.