NCT01585155

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2012

Typical duration for phase_3

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 25, 2012

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
5.1 years until next milestone

Results Posted

Study results publicly available

October 21, 2019

Completed
Last Updated

January 7, 2026

Status Verified

December 1, 2025

Enrollment Period

2.6 years

First QC Date

April 24, 2012

Results QC Date

September 25, 2019

Last Update Submit

December 15, 2025

Conditions

Pediatric Ulcerative Colitis

Keywords

InfliximabREMICADETA-650

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • 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

Study Arms (1)

TA-650

EXPERIMENTAL
Drug: TA-650

Interventions

TA-650DRUG

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.

TA-650

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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.).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Investigational site

Chūbu, Japan

Location

Investigational site

Hokkaido, Japan

Location

Investigational site

Hokuriku, Japan

Location

Investigational site

Kanto, Japan

Location

Investigational site

Kinki, Japan

Location

Investigational site

Kyusyu, Japan

Location

Investigational site

Tōhoku, Japan

Location

Related Publications (1)

  • 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.

    PMID: 31607268RESULT

MeSH Terms

Conditions

Pediatric ulcerative colitis

Results Point of Contact

Title
Clinical Trials, Information Desk
Organization
Tanabe Pharma Corporation
cti-inq-ml.JP@ml.tanabe-pharma.com

Study Officials

  • Toshifumi Hibi, MD

    Kitasato University Kitasato Institute Hospital

    STUDY DIRECTOR

  • Kazuoki Kondo, MD

    Mitsubihsi Tanabe Pharma Corporation

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2012

First Posted

April 25, 2012

Study Start

February 1, 2012

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

January 7, 2026

Results First Posted

October 21, 2019

Record last verified: 2025-12

Locations

JP(7)