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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT00805766
Date of registration: 09/12/2008
Prospective Registration: Yes
Primary sponsor: Mitsubishi Tanabe Pharma Corporation
Public title: Efficacy and Safety of Increased Dose of TA-650 (Infliximab) in Patients With Crohn's Disease (CD)
Scientific title: Clinical Study to Assess the Efficacy and Safety of Increased Dose of TA-650 in Patients With Crohn's Disease (CD)
Date of first enrolment: December 2008
Target sample size: 39
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00805766
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 3
Countries of recruitment
Japan
Contacts
Name:     Toshifumi Hibi, Professor
Address: 
Telephone:
Email:
Affiliation:  Department of Internal Medicine, Keio University School of Medicine
Key inclusion & exclusion 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



Age minimum: 16 Years
Age maximum: 75 Years
Gender: All
Health Condition(s) or Problem(s) studied
Crohn's Disease
Intervention(s)
Drug: TA-650
Primary Outcome(s)
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)]
Secondary Outcome(s)
Antibody to TA-650 Determination [Time Frame: Screening Period (Week 0 to Week 16), Increased Dose Period (Week 0 to Week 40)]
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 Change at Each Evaluation Time Point in the Increased Dose Period [Time Frame: Increased Dose Period (every 4 weeks for up to 40 weeks)]
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)]
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]
Secondary ID(s)
TA-650-19
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 05/12/2012
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT00805766
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