Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT00805766
First received: December 9, 2008
Last updated: December 5, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Crohn's Disease
Drug: TA-650
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Study to Assess the Efficacy and Safety of Increased Dose of TA-650 in Patients With Crohn's Disease (CD)

Resource links provided by NLM:


Further study details as provided by Mitsubishi Tanabe Pharma Corporation:

Primary Outcome Measures:
  • Median Crohn's Disease Activity Index (CDAI) Change From Week 0 to Week 8 in the Increased Dose Period [ Time Frame: Week 0 to Week 8 ] [ Designated as safety issue: No ]
    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 [ Time Frame: every 4 weeks for up to 40 weeks ] [ Designated as safety issue: No ]
  • CDAI Remission Rates at Each Evaluation Time Point in the Increased Dose Period [ Time Frame: every 4 weeks for up to 40 weeks ] [ Designated as safety issue: No ]
  • CDAI Change at Each Evaluation Time Point in the Increased Dose Period [ Time Frame: every 4 weeks for up to 40 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: every 4 weeks for up to 40 weeks ] [ Designated as safety issue: No ]
  • Antibody to TA-650 Determination [ Time Frame: Weeks 24 and 40 ] [ Designated as safety issue: No ]

Enrollment: 39
Study Start Date: December 2008
Study Completion Date: July 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TA-650 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.
Other Name: Infliximab

  Eligibility

Ages Eligible for Study:   16 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00805766

Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
Investigators
Study Chair: Toshifumi Hibi, Professor Department of Internal Medicine, Keio University School of Medicine
  More Information

No publications provided

Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT00805766     History of Changes
Other Study ID Numbers: TA-650-19
Study First Received: December 9, 2008
Results First Received: September 2, 2012
Last Updated: December 5, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Mitsubishi Tanabe Pharma Corporation:
Infliximab
REMICADE
Crohn's disease

Additional relevant MeSH terms:
Crohn Disease
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases
Infliximab
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Dermatologic Agents
Gastrointestinal Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014