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

Tanabe Pharma Corporation

Status and phase: Completed; Phase 3

Conditions: Crohn's Disease

Treatments: Drug: TA-650

Study type: Interventional

Funder types: Industry

Identifiers

NCT00805766

TA-650-19

Details and patient eligibility

About

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.

Enrollment: 39 patients

Sex: All

Ages: 16 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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39 participants in 1 patient group

TA-650

Experimental group

Treatment:

Drug: TA-650