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

Crohn's Disease Clinical Trial

Official title:

Clinical Study to Assess the Efficacy and Safety of Increased Dose of TA-650 in Patients With Crohn's Disease (CD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00805766
• Other study ID #: TA-650-19
• Status: Completed
• Phase: Phase 3
• First received: December 9, 2008
• Last updated: January 15, 2018
• Start date: December 2008
• Est. completion date: July 2010

Study information

• Verified date: January 2018
• Source: Mitsubishi Tanabe Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: July 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Drug:
• TA-650
(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.

Locations

Country	Name	City	State
Japan	Investigational site	Hokkaido
Japan	Investigational site	Kansai
Japan	Investigational site	Kanto
Japan	Investigational site	Kyushu

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Increased Dose Period (Week 0 to Week 8)
Secondary	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.	Increased Dose Period (every 4 weeks for up to 40 weeks)
Secondary	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.	Increased Dose Period (every 4 weeks for up to 40 weeks)
Secondary	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.	Increased Dose Period (every 4 weeks for up to 40 weeks)
Secondary	Serum Concentration of TA-650 at Each Time Point		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
Secondary	Antibody to TA-650 Determination		Screening Period (Week 0 to Week 16), Increased Dose Period (Week 0 to Week 40)