Unique ID issued by UMIN | UMIN000005251 |
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Receipt number | R000006243 |
Scientific 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 |
Date of disclosure of the study information | 2011/06/01 |
Last modified on | 2014/09/22 16:35:46 |
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
Methotrexate in Crohn's disease patients who lost response or showed intolerance to infliximab
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
Methotrexate in Crohn's disease patients who lost response or showed intolerance to infliximab
Japan |
Crohn's disease
Gastroenterology | Adult | Child |
Others
NO
To investigate the efficacy and safety of methotrexate in patients with Crohn's disease who has activity disease regardless of scheduled infliximab treatment, or who had discontinued infliximab because of treatment failure or intolerance
Safety,Efficacy
Remission rate at week 16
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
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.
16 | years-old | <= |
Not applicable |
Male and Female
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
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
14
1st name | |
Middle name | |
Last name | Masakazu Nagahori |
Tokyo Medical and Dental University
Department of Gastroenterology and Hepatology
1-4-45 Yushima Bunkyo-ku Tokyo, Japan
1st name | |
Middle name | |
Last name |
Tokyo Medical and Dental University
Department of Gastroenterology and Hepatology
03-5803-5974
nagahori.gast@tmd.ac.jp
Department of Gastroenterology and Hepatology, Tokyo Medical and Dental University
Tokyo Medical and Dental University
Self funding
NO
2011 | Year | 06 | Month | 01 | Day |
Unpublished
Completed
2011 | Year | 03 | Month | 15 | Day |
2011 | Year | 06 | Month | 01 | Day |
2011 | Year | 03 | Month | 15 | Day |
2014 | Year | 09 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006243
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