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Efficacy and Safety of Increased Dose of TA-650 (Infliximab) in Patients With Crohn's Disease (CD)

Primary Purpose

Crohn's Disease

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 Crohn's Disease focused on measuring Infliximab, REMICADE, Crohn's disease

Eligibility Criteria

16 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with Crohn's disease
  • Patients who have relapsed with symptoms associated with Crohn's disease within 8 weeks in spite of maintenance treatment with 5mg/kg REMICADE every 8 weeks, and who are judged to be showing an insufficient response to the previous treatment by their physician

Exclusion Criteria:

  • Severe intestinal strictures (which may have an effect on the number of loose stools or diarrhea or dilation of the colon or small bowel proximal to the stricture on barium radiograph or an inability to traverse the stricture at endoscopy), a diagnosis of short bowel syndrome, or previous stoma surgery
  • The presence of significant internal fistula (possibility that surgery might be needed, etc.) is confirmed
  • A history of a serious infusion reaction to REMICADE
  • Pregnant, lactating, and probably pregnant women
  • Patients who have participated in other trials and have been administered other investigational products within 12 weeks before consent
  • Patients judged to be inadequate to participate in this study by their physician

Sites / Locations

  • 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

Median Crohn's Disease Activity Index (CDAI) Change From Week 0 to Week 8 in the Increased Dose Period
To confirm the decrease in median CDAI at week 8 by ≥ 50 points compared to the CDAI score at week 0 in the increased dose period. In the indication of CDAI change, decrease in CDAI was expressed by positive numbers. CDAI is a research tool used to quantify the symptoms of patients with Crohn's disease. CDAI scores generally range from 0 to 600 points. Clinical remission = CDAI < 150 points. Moderate disease = CDAI 220 - 450 points. Severe disease = CDAI > 450 points.

Secondary Outcome Measures

CDAI at Each Evaluation Time Point in the Increased Dose Period
CDAI is a research tool used to quantify the symptoms of patients with Crohn's disease. CDAI scores generally range from 0 to 600 points. Clinical remission = CDAI < 150 points. Moderate disease = CDAI 220 - 450 points. Severe disease = CDAI > 450 points.
CDAI Remission Rates at Each Evaluation Time Point in the Increased Dose Period
CDAI is a research tool used to quantify the symptoms of patients with Crohn's disease. CDAI scores generally range from 0 to 600 points. Clinical remission = CDAI < 150 points. Moderate disease = CDAI 220 - 450 points. Severe disease = CDAI > 450 points.
CDAI Change at Each Evaluation Time Point in the Increased Dose Period
To confirm the decrease in median CDAI at week 8 by ≥ 50 points compared to the CDAI score at week 0 in the increased dose period. In the indication of CDAI change, decrease in CDAI was expressed by positive numbers. CDAI is a research tool used to quantify the symptoms of patients with Crohn's disease. CDAI scores generally range from 0 to 600 points. Clinical remission = CDAI < 150 points. Moderate disease = CDAI 220 - 450 points. Severe disease = CDAI > 450 points.
Serum Concentration of TA-650 at Each Time Point
Antibody to TA-650 Determination

Full Information

First Posted
December 9, 2008
Last Updated
January 15, 2018
Sponsor
Mitsubishi Tanabe Pharma Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00805766
Brief Title
Efficacy and Safety of Increased Dose of TA-650 (Infliximab) in Patients With Crohn's Disease (CD)
Official Title
Clinical Study to Assess the Efficacy and Safety of Increased Dose of TA-650 in Patients With Crohn's Disease (CD)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
July 2010 (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 assess the efficacy, safety and pharmacokinetics after administration of 10mg/kg TA-650 every 8 weeks to patients with Crohn's disease showing an insufficient response to previous treatment with 5 mg/kg of REMICADE every 8 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
Infliximab, REMICADE, 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
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TA-650
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
TA-650
Other Intervention Name(s)
Infliximab
Intervention Description
(1) Screening Period: 5 mg/kg of TA-650 will be intravenously infused over a period of more than 2 hours at week 0. If patients do not meet the Eligibility Criteria at week 8, they will be administered 5 mg/kg of TA-650 at week 8. (2) Increased Dose Period: 10 mg/kg of TA-650 will be intravenously infused over a period of more than 2 hours every 8 weeks for 32 weeks.
Primary Outcome Measure Information:
Title
Median Crohn's Disease Activity Index (CDAI) Change From Week 0 to Week 8 in the Increased Dose Period
Description
To confirm the decrease in median CDAI at week 8 by ≥ 50 points compared to the CDAI score at week 0 in the increased dose period. In the indication of CDAI change, decrease in CDAI was expressed by positive numbers. CDAI is a research tool used to quantify the symptoms of patients with Crohn's disease. CDAI scores generally range from 0 to 600 points. Clinical remission = CDAI < 150 points. Moderate disease = CDAI 220 - 450 points. Severe disease = CDAI > 450 points.
Time Frame
Increased Dose Period (Week 0 to Week 8)
Secondary Outcome Measure Information:
Title
CDAI at Each Evaluation Time Point in the Increased Dose Period
Description
CDAI is a research tool used to quantify the symptoms of patients with Crohn's disease. CDAI scores generally range from 0 to 600 points. Clinical remission = CDAI < 150 points. Moderate disease = CDAI 220 - 450 points. Severe disease = CDAI > 450 points.
Time Frame
Increased Dose Period (every 4 weeks for up to 40 weeks)
Title
CDAI Remission Rates at Each Evaluation Time Point in the Increased Dose Period
Description
CDAI is a research tool used to quantify the symptoms of patients with Crohn's disease. CDAI scores generally range from 0 to 600 points. Clinical remission = CDAI < 150 points. Moderate disease = CDAI 220 - 450 points. Severe disease = CDAI > 450 points.
Time Frame
Increased Dose Period (every 4 weeks for up to 40 weeks)
Title
CDAI Change at Each Evaluation Time Point in the Increased Dose Period
Description
To confirm the decrease in median CDAI at week 8 by ≥ 50 points compared to the CDAI score at week 0 in the increased dose period. In the indication of CDAI change, decrease in CDAI was expressed by positive numbers. CDAI is a research tool used to quantify the symptoms of patients with Crohn's disease. CDAI scores generally range from 0 to 600 points. Clinical remission = CDAI < 150 points. Moderate disease = CDAI 220 - 450 points. Severe disease = CDAI > 450 points.
Time Frame
Increased Dose Period (every 4 weeks for up to 40 weeks)
Title
Serum Concentration of TA-650 at Each Time Point
Time Frame
Screening Period (every 4 weeks for up to 16 weeks), Increased Dose Period (every 4 weeks for up to 40 weeks), a total of 56 weeks
Title
Antibody to TA-650 Determination
Time Frame
Screening Period (Week 0 to Week 16), Increased Dose Period (Week 0 to Week 40)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with Crohn's disease Patients who have relapsed with symptoms associated with Crohn's disease within 8 weeks in spite of maintenance treatment with 5mg/kg REMICADE every 8 weeks, and who are judged to be showing an insufficient response to the previous treatment by their physician Exclusion Criteria: Severe intestinal strictures (which may have an effect on the number of loose stools or diarrhea or dilation of the colon or small bowel proximal to the stricture on barium radiograph or an inability to traverse the stricture at endoscopy), a diagnosis of short bowel syndrome, or previous stoma surgery The presence of significant internal fistula (possibility that surgery might be needed, etc.) is confirmed A history of a serious infusion reaction to REMICADE Pregnant, lactating, and probably pregnant women Patients who have participated in other trials and have been administered other investigational products within 12 weeks before consent Patients judged to be inadequate to participate in this study by their physician
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Toshifumi Hibi, Professor
Organizational Affiliation
Department of Internal Medicine, Keio University School of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Investigational site
City
Hokkaido
Country
Japan
Facility Name
Investigational site
City
Kansai
Country
Japan
Facility Name
Investigational site
City
Kanto
Country
Japan
Facility Name
Investigational site
City
Kyushu
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

Efficacy and Safety of Increased Dose of TA-650 (Infliximab) in Patients With Crohn's Disease (CD)

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