ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00805766
Recruitment Status : Completed
First Posted : December 10, 2008
Results First Posted : December 5, 2012
Last Update Posted : February 9, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Crohn's Disease Drug: TA-650 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Intervention Model: Single Group Assignment
Masking: None (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)
Study Start Date : December 2008
Actual Primary Completion Date : November 2009
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
Drug Information available for: Infliximab
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Median Crohn's Disease Activity Index (CDAI) Change From Week 0 to Week 8 in the Increased Dose Period [ Time Frame: 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 :
  1. CDAI at Each Evaluation Time Point in the Increased Dose Period [ Time Frame: 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.

  2. CDAI Remission Rates at Each Evaluation Time Point in the Increased Dose Period [ Time Frame: 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.

  3. CDAI Change at Each Evaluation Time Point in the Increased Dose Period [ Time Frame: 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.

  4. Serum Concentration of TA-650 at Each Time Point [ Time Frame: 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 ]
  5. Antibody to TA-650 Determination [ Time Frame: Screening Period (Week 0 to Week 16), Increased Dose Period (Week 0 to Week 40) ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   16 Years to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00805766


Locations
Japan
Investigational site
Hokkaido, Japan
Investigational site
Kansai, Japan
Investigational site
Kanto, Japan
Investigational site
Kyushu, Japan
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
Investigators
Study Chair: Toshifumi Hibi, Professor Department of Internal Medicine, Keio University School of Medicine

Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT00805766     History of Changes
Other Study ID Numbers: TA-650-19
First Posted: December 10, 2008    Key Record Dates
Results First Posted: December 5, 2012
Last Update Posted: February 9, 2018
Last Verified: January 2018

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

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Infliximab
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents