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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-UMIN000005251
Date of registration: 01/06/2011
Prospective Registration: Yes
Primary sponsor: Department of Gastroenterology and Hepatology, Tokyo Medical and Dental University
Public title: A prospective open-label study to investigate the efficacy and safety of methotrexate in Crohn's disease patients who lost response or showed intolerance to infliximab
Scientific title:
Date of first enrolment: 2011/06/01
Target sample size: 14
Recruitment status: Complete: follow-up complete
URL:  https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006243
Study type:  Interventional
Study design:  Single arm Non-randomized  
Phase:  Not selected
Countries of recruitment
Japan
Contacts
Name:    
Address:  Japan
Telephone: 03-5803-5974
Email: nagahori.gast@tmd.ac.jp
Affiliation:  Tokyo Medical and Dental University Department of Gastroenterology and Hepatology
Name: Masakazu Nagahori   
Address:  1-4-45 Yushima Bunkyo-ku Tokyo, Japan Japan
Telephone:
Email:
Affiliation:  Tokyo Medical and Dental University Department of Gastroenterology and Hepatology
Key inclusion & exclusion criteria
Inclusion criteria: Patients with active disease who had CDAI(Crohn's Disease Activity Index) above 200 at 8-week scheduled infliximab treatment or who had CDAI above 200, where infliximab had been discontinued because of inefficacy or intolerance
Patients who were explained the study schedule and agreed to participate by their own will, accompanied by written informed consent
When patients are under the age of 20, written informed consent must be obtained by their legal guardians as well as by themselves
Patients can be either inpatients or outpatients

Exclusion criteria: Either patients
who have ostomy
who have obstructive symptoms
who are complicated by severe infection such as abscess
whoes white cell count is less than 3,000
whoes platelet count is less than 10,000
whoes Hb is less than 8.0g/dL
who have severe cardiac disease
who have severe renal disease
who have severe liver disease such as
AST or ALT level is above the upper normal limit
liver cirrhosis
who haves severe respiratory disease
who are pregnant, or whoes partner is considering of pregnancy
who started or increased the dosage of corticosteroids within 2 weeks before the study initiation
who started or increase the dosage of immunomodulator (azathioprine or 6-mercaptopurine) within 2 weeks before the study initiation
who are considered by study investigators to be inappropriate to be included in the study


Age minimum: 16years-old
Age maximum: Not applicable
Gender: Male and Female
Health Condition(s) or Problem(s) studied
Crohn's disease
Intervention(s)
Administration of oral methotrexate 15mg divided after breakfast and dinner weekly for 16 weeks.If remission(CDAI<150) cannot be obtained at week 8, the dose of methotrexate can be increased to 25mg weekly.
Primary Outcome(s)
Remission rate at week 16
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
Tokyo Medical and Dental University
Secondary Sponsor(s)
Ethics review
Status:
Approval date:
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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