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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: JPRN
Last refreshed on: 2 April 2019
Main ID:  JPRN-UMIN000004427
Date of registration: 01/11/2010
Prospective Registration: No
Primary sponsor: Lower GI disease, Hyogo College of Medicine
Public title: A Prospective Randomized Open Trial to Assess the Efficiency of Infliximab for Crohn's Patients after Intestinal Resection
Scientific title:
Date of first enrolment: 2007/06/01
Target sample size: 30
Recruitment status: Complete: follow-up complete
URL:  https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005290
Study type:  Interventional
Study design:  Parallel Randomized  
Phase:  Phase II,III
Countries of recruitment
Japan
Contacts
Name: Ken Fukunaga   
Address:  1-1 Mukogawa, Nishinomiya, Hyogo Pref. Japan
Telephone:
Email:
Affiliation:  Hyogo College of Medicine Lower GI disease
Name: Takayuki Matsumoto   
Address:  1-1 Mukogawa, Nishinomiya, Hyogo Pref. Japan
Telephone:
Email:
Affiliation:  Hyogo College of Medicine Lower GI disease
Key inclusion & exclusion criteria
Inclusion criteria: 1. A patient who is diagnosed as Crohn's disease (ilititis, colitis, or ileocolitis type).
2. A patient who has the first intestinal resection within 8weeks prior to enroll this trial.
3. A patient who has not been given any immunomodulator(s), such as Azathioprine, 6-Mercaptopurine, within 8 weeks prior to enroll the trial.
4. A patient who has judged not to have other active CD lesion(s) expects the rejected lesion by either just before or during the operation. (judged by a doctor in charge)
5. A patient who is 16 to 64 years old and has written his (her) signature to a document for agreement (If a patient is under 20 years old, a signature of his (her) legal representative is necessary).

Exclusion criteria: 1. A patient who has had hypersensitivity to infliximab.
2. A patient who has had a surgery for anal lesion (without intestinal resection) as a reason to be involved for this trial.
3. A patient who has abscess lesion(s).
4. A patient who has past and/or present episode of tuberoses infection.
5. A patient who is determined as ineligible for a subject in this study by a doctor in charge or others.


Age minimum: 16years-old
Age maximum: 65years-old
Gender: Male and Female
Health Condition(s) or Problem(s) studied
Crohn's disease
Intervention(s)
Non-infliximab arm:
Conventional medicine is administered, excluding Infliximab, Azathioprine, and 6-Mercaptopurine, to subjects during the study period (for 60 months, maximum).

Infliximab arm:
Infliximab is administered to subjects during the study period (for 60 months, maximum) together with other conventional medications, such as 5-aminosalicylic acid. Infliximab is administered every 8 weeks to subjects during study period after the start of protocol treatment as a rule. Immunomodulators, such as Azathioprine and 6-Mercaptopurine, are not permitted during the trial.
Primary Outcome(s)
Remission rate at 12 months after the start of protocol treatment
(Full Analysis Set; Discontinuation of protocol treatment is accounted to be non-remission.)
Secondary Outcome(s)
Evaluation of efficiency: Remission ratios at 24 months (and 60 months, maximum) after start of protocol treatment, Ratio of the protocol continuation, Clinical activity in both the CDAI and IOIBD, IBDQ score, CRP value, etc.
Evaluation of safety: Adverse event, Abnormal values in blood test, etc.
Secondary ID(s)
Source(s) of Monetary Support
Lower GI disease, Hyogo College of Medicine
Secondary Sponsor(s)
Ethics review
Status:
Approval date:
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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