Crohn'
Conditions
Interventions
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.
Sponsors
Department of Gastroenterology and Hepatology, Tokyo Medical and Dental University
Eligibility
Sex/Gender
All
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Remission rate at week 16 | — |
Countries
Japan
Outcome results
None listed