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

Primary Purpose

Pediatric Ulcerative Colitis

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
TA-650
Sponsored by
Mitsubishi Tanabe Pharma Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pediatric Ulcerative Colitis focused on measuring Infliximab, REMICADE, TA-650

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.).

Sites / Locations

  • Investigational site
  • Investigational site
  • Investigational site
  • Investigational site
  • Investigational site
  • Investigational site
  • Investigational site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TA-650

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

CAI Score
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.
Partial Mayo Score
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.
Pediatric Ulcerative Colitis Activity Index (PUCAI) Score
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.

Full Information

First Posted
April 24, 2012
Last Updated
October 23, 2019
Sponsor
Mitsubishi Tanabe Pharma Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01585155
Brief Title
Clinical Study of TA-650 in Pediatric Patients With Ulcerative Colitis
Official Title
Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of TA-650 in Pediatric Patients With Moderate to Severe Ulcerative Colitis.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mitsubishi Tanabe Pharma Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Ulcerative Colitis
Keywords
Infliximab, REMICADE, TA-650

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TA-650
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
TA-650
Intervention Description
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 Outcome Measure Information:
Title
Percent of Patients Who Achieved CAI Remission
Description
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.
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
Secondary Outcome Measure Information:
Title
CAI Score
Description
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.
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
Title
Partial Mayo Score
Description
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.
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
Title
Pediatric Ulcerative Colitis Activity Index (PUCAI) Score
Description
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.
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Toshifumi Hibi, MD
Organizational Affiliation
Kitasato University Kitasato Institute Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kazuoki Kondo, MD
Organizational Affiliation
Mitsubihsi Tanabe Pharma Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Investigational site
City
Chubu
Country
Japan
Facility Name
Investigational site
City
Hokkaido
Country
Japan
Facility Name
Investigational site
City
Hokuriku
Country
Japan
Facility Name
Investigational site
City
Kanto
Country
Japan
Facility Name
Investigational site
City
Kinki
Country
Japan
Facility Name
Investigational site
City
Kyusyu
Country
Japan
Facility Name
Investigational site
City
Tohoku
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
31607268
Citation
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.
Results Reference
result

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

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