Clinical Study of TA-650 in Pediatric Patients With Crohn's Disease

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

TA-650

About this trial

This is an interventional treatment trial for Pediatric Crohn's Disease focused on measuring Infliximab, REMICADE, TA-650, pediatric Crohn's disease

Eligibility Criteria

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

Inclusion Criteria:

Patients who have been diagnosed as Crohn's disease at least 3 months prior to screening.
Have active Crohn's disease despite adequate conventional therapy.

Exclusion Criteria:

Patients with severe intestinal strictures (strictures which may affect the number of defecations, etc., or dilation of the colon or strictures in the proximal small bowel observed on barium radiograph, or strictures precluding the insertion of endoscope), a diagnosis of short bowel syndrome, or previous stoma surgery.
Patients who have a history of treatment with infliximab, or biological products (anti-TNFα agents and 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

Responder criteria: Case where PCDAI score on the evaluation day was decreased by at least 15 points from that in the screening period and was ≤30. Criteria for dose-increasing: When either of the following 2 items was satisfied after Week 14, the relevant patient would be considered to satisfy the criteria for dose increasing to 10 mg/kg. PCDAI score on the evaluation day was increased by at least 15 points compared to the lowest PCDAI score observed at Week 2, 6 or 10 PCDAI score on the evaluation day exceeds 30

Outcomes

Primary Outcome Measures

Percent of Patients Who Achieved PCDAI Response

Crohn's Disease Activity Index(PCDAI) response was defined as a case where PCDAI on the evaluation day was decreased by at least 15 points compared to PCDAI in the screening period and decreased to not more than 30. PCDAI was the sum (0 to 100) of the scores of 5 large categories. A larger PCDAI score represented higher disease activity. 5 large categories were as follows, i.e. history score (0 to 30), laboratory score (0 to 20), growth score (0 to 20), physical examination score (0 to 20) and extraintestinal manifestation score (0 to 10).

Secondary Outcome Measures

PCDAI Score

Crohn's Disease Activity Index (PCDAI) was the sum (0 to 100) of the scores of 5 large categories. A larger PCDAI score represented higher disease activity. 5 large categories were as follows, i.e. history score (0 to 30), laboratory score (0 to 20), growth score (0 to 20), physical examination score (0 to 20) and extraintestinal manifestation score (0 to 10).

Change From Baseline of PCDAI Score

Crohn's Disease Activity Index (PCDAI) was the sum (0 to 100) of the scores of 5 large categories. A larger PCDAI score represented higher disease activity. 5 large categories were as follows, i.e. history score (0 to 30), laboratory score (0 to 20), growth score (0 to 20), physical examination score (0 to 20) and extraintestinal manifestation score (0 to 10).

Percent of Patients Who Achieved PCDAI-Based Remission Rate.

Crohn's Disease Activity Index(PCDAI)-based remission was defined as a case where PCDAI on the evaluation day was decreased to not more than 10. Patients who satisfied the criterion for PCDAI response at least once in the evaluation at Week 2, 6 and 10 were defined as responders at Week 10. PCDAI was the sum (0 to 100) of the scores of 5 large categories. A larger PCDAI score represented higher disease activity. 5 large categories were as follows, i.e. history score (0 to 30), laboratory score (0 to 20), growth score (0 to 20), physical examination score (0 to 20) and extraintestinal manifestation score (0 to 10).

Serum TA-650 Concentration

Median, Min and Max of serum TA-650 concentration at each evaluation point after dose of 5 mg/kg TA-650.

The Percent of the Patients Who Experienced an Adverse Event

Full Information

NCT ID

NCT01580670

First Posted

April 3, 2012

Last Updated

July 11, 2019

Sponsor

Mitsubishi Tanabe Pharma Corporation

1. Study Identification

Unique Protocol Identification Number

NCT01580670

Brief Title

Clinical Study of TA-650 in Pediatric Patients With Crohn's Disease

Official Title

Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of TA-650 in Pediatric Patients With Moderate to Severe Crohn's Disease

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Completed

Study Start Date

March 2012 (undefined)

Primary Completion Date

March 2015 (Actual)

Study Completion Date

March 2015 (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 efficacy of TA-650 using Pediatric Crohn's Disease Activity Index (PCDAI) in pediatric patients with moderate to severe Crohn's disease after TA-650 administration at a dose of 5 mg/kg at week 0, 2, and 6, then every 8 week after week 14 up to week 46, and at a dose of 10 mg/kg if the effect is attenuated. The safety and pharmacokinetics are also evaluated.

Detailed Description

This is an open-label, uncontrolled, multicenter Phase 3 study conducted in Japan.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pediatric Crohn's Disease

Keywords

Infliximab, REMICADE, TA-650, pediatric Crohn's disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TA-650

Arm Type

Experimental

Arm Description

Responder criteria: Case where PCDAI score on the evaluation day was decreased by at least 15 points from that in the screening period and was ≤30. Criteria for dose-increasing: When either of the following 2 items was satisfied after Week 14, the relevant patient would be considered to satisfy the criteria for dose increasing to 10 mg/kg. PCDAI score on the evaluation day was increased by at least 15 points compared to the lowest PCDAI score observed at Week 2, 6 or 10 PCDAI score on the evaluation day exceeds 30

Intervention Type

Drug

Intervention Name(s)

TA-650

Other Intervention Name(s)

Infliximab

Intervention Description

TA-650 will be intravenously infused at 5 mg/kg as an induction regimen at Week 0, 2, 6. For subjects who meet the responder criteria, TA-650 will be administered at 8-week intervals thereafter until week 46. If the criteria for a dosage escalation are met, TA-650 will be administered at a dosage of 10 mg/kg.

Primary Outcome Measure Information:

Title

Percent of Patients Who Achieved PCDAI Response

Description

Crohn's Disease Activity Index(PCDAI) response was defined as a case where PCDAI on the evaluation day was decreased by at least 15 points compared to PCDAI in the screening period and decreased to not more than 30. PCDAI was the sum (0 to 100) of the scores of 5 large categories. A larger PCDAI score represented higher disease activity. 5 large categories were as follows, i.e. history score (0 to 30), laboratory score (0 to 20), growth score (0 to 20), physical examination score (0 to 20) and extraintestinal manifestation score (0 to 10).

Time Frame

Week 2, 6, 10, 14, 18, 22, 26, 30, 34, 38, 42, 46, 50, 54, and the last time point during the period from administration of the study drug to Week 54

Secondary Outcome Measure Information:

Title

PCDAI Score

Description

Crohn's Disease Activity Index (PCDAI) was the sum (0 to 100) of the scores of 5 large categories. A larger PCDAI score represented higher disease activity. 5 large categories were as follows, i.e. history score (0 to 30), laboratory score (0 to 20), growth score (0 to 20), physical examination score (0 to 20) and extraintestinal manifestation score (0 to 10).

Time Frame

Week 0, 2, 6, 10, 14, 18, 22, 26, 30, 34, 38, 42, 46, 50, 54, and the last time point during the period from administration of the study drug to Week 54

Title

Change From Baseline of PCDAI Score

Description

Crohn's Disease Activity Index (PCDAI) was the sum (0 to 100) of the scores of 5 large categories. A larger PCDAI score represented higher disease activity. 5 large categories were as follows, i.e. history score (0 to 30), laboratory score (0 to 20), growth score (0 to 20), physical examination score (0 to 20) and extraintestinal manifestation score (0 to 10).

Time Frame

Week 0, 2, 6, 10, 14, 18, 22, 26, 30, 34, 38, 42, 46, 50, 54, and the last time point during the period from administration of the study drug to Week 54

Title

Percent of Patients Who Achieved PCDAI-Based Remission Rate.

Description

Crohn's Disease Activity Index(PCDAI)-based remission was defined as a case where PCDAI on the evaluation day was decreased to not more than 10. Patients who satisfied the criterion for PCDAI response at least once in the evaluation at Week 2, 6 and 10 were defined as responders at Week 10. PCDAI was the sum (0 to 100) of the scores of 5 large categories. A larger PCDAI score represented higher disease activity. 5 large categories were as follows, i.e. history score (0 to 30), laboratory score (0 to 20), growth score (0 to 20), physical examination score (0 to 20) and extraintestinal manifestation score (0 to 10).

Time Frame

Week 2, 6, 10, 14, 18, 22, 26, 30, 34, 38, 42, 46, 50, 54 and the last time point during the period from administration of the study drug to Week 54

Title

Serum TA-650 Concentration

Description

Median, Min and Max of serum TA-650 concentration at each evaluation point after dose of 5 mg/kg TA-650.

Time Frame

After dose of Week 0 to 54 or at the timing of discontinuation. On the blood sampling day, before administration of the study drug. Week 0, 22 and 46, before administration and one hour after the administration. Week 14, 30 and 38, before administration.

Title

The Percent of the Patients Who Experienced an Adverse Event

Time Frame

Until the last time point during the period from administration of the study drug to Week 54

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 Crohn's disease at least 3 months prior to screening. Have active Crohn's disease despite adequate conventional therapy. Exclusion Criteria: Patients with severe intestinal strictures (strictures which may affect the number of defecations, etc., or dilation of the colon or strictures in the proximal small bowel observed on barium radiograph, or strictures precluding the insertion of endoscope), a diagnosis of short bowel syndrome, or previous stoma surgery. Patients who have a history of treatment with infliximab, or biological products (anti-TNFα agents and 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

30114224

Citation

Tajiri H, Motoya S, Kinjo F, Maemoto A, Matsumoto T, Sato N, Yamada H, Nagano M, Susuta Y, Ozaki K, Kondo K, Hibi T. Infliximab for pediatric patients with Crohn's disease: A Phase 3, open-label, uncontrolled, multicenter trial in Japan. PLoS One. 2018 Aug 16;13(8):e0201956. doi: 10.1371/journal.pone.0201956. eCollection 2018. Erratum In: PLoS One. 2022 Apr 19;17(4):e0261932.

Results Reference

result

Pediatric Crohn's Disease

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial