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

Phase 3

Completed

• Conditions: Crohn's Disease
• Interventions: Drug: TA-650

• Registration Number: NCT00805766
• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2008-12-09
• Study First Submitted QC: 2008-12-09
• Study First Posted: 2008-12-10
• Primary Completion: 2009-11
• Study Completion: 2010-07
• Results First Submitted: 2012-09-02
• Results First Submitted QC: 2012-11-07
• Results First Posted: 2012-12-05
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-15
• Last Update Posted: 2018-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TA-650	TA-650	-

Primary Outcome Measures

Name	Time	Method
Median Crohn's Disease Activity Index (CDAI) Change From Week 0 to Week 8 in the Increased Dose Period	Increased Dose Period (Week 0 to Week 8)	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

Name	Time	Method
Antibody to TA-650 Determination	Screening Period (Week 0 to Week 16), Increased Dose Period (Week 0 to Week 40)
CDAI Change at Each Evaluation Time Point in the Increased Dose Period	Increased Dose Period (every 4 weeks for up to 40 weeks)	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.
CDAI at Each Evaluation Time Point in the Increased Dose Period	Increased Dose Period (every 4 weeks for up to 40 weeks)	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	Increased Dose Period (every 4 weeks for up to 40 weeks)	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	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

Trial Locations

Locations (1)

Investigational site; 🇯🇵 Kyushu, Japan