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

NCT00805766 | Completed Phase 3 Results

• 1 other identifier: TA-650-19
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 4

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.

Conditions

Crohn's Disease

Keywords

Infliximab; REMICADE; Crohn's disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• CDAI at Each Evaluation Time Point in the Increased Dose Period

  Increased Dose Period (every 4 weeks for up to 40 weeks)

• 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 Change at Each Evaluation Time Point in the Increased Dose Period

  Increased Dose Period (every 4 weeks for up to 40 weeks)

• 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

• Antibody to TA-650 Determination

  Screening Period (Week 0 to Week 16), Increased Dose Period (Week 0 to Week 40)

Study Arms (1)

TA-650

EXPERIMENTAL

Drug: TA-650

Interventions

TA-650 DRUG

(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.

Also known as: Infliximab

TA-650

Eligibility Criteria

• Age: 16 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanabe Pharma Corporation: lead

Study Sites (4)

Investigational site

Hokkaido, Japan

Location

Investigational site

Kansai, Japan

Location

Investigational site

Kanto, Japan

Location

Investigational site

Kyushu, Japan

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

Infliximab

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Clinical Trials, Information Desk
• Organization: Tanabe Pharma Corporation

cti-inq-ml.JP@ml.tanabe-pharma.com

Study Officials

• Toshifumi Hibi, Professor

  Department of Internal Medicine, Keio University School of Medicine

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2008
• First Posted: December 10, 2008
• Study Start: December 1, 2008
• Primary Completion: November 1, 2009
• Study Completion: July 1, 2010
• Last Updated: January 7, 2026
• Results First Posted: December 5, 2012

Record last verified: 2025-12

Locations

JP (4)