ulcerative colitis
Conditions
Interventions
stop every-8-week administration of IFX
continue administration of IFX every 8 weeks
Sponsors
Center for Clinical Research, Keio University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who are diagnosed as UC based on the diagnostic criteria of Reserch Group of Intractable Inflammatory Bowel Disease (2011). 2) Patients on 5mg/kg of IFX every 8 weeks after induction at week 0, 2, 6 week. 3) Patients who are assessed their clinical activity by Clinical Activity Index (CAI) after 14th week of IFX. 4) Patients whose disease activity is 4 or lower by CAI. 5) Patients who received full-explanation and completely understood the study. Informed consent by the document is required.
Exclusion criteria
Exclusion criteria: 1) Patients who are maintained remission for longer than 16 weeks. 2) Patients who have relapsed after once induced remission but before registered to the study. 3) Females who are pregnant, breast-feeding, or cannot exclude the possibility of pregnancy. 4) Patients who have a history of severe infusion reaction. 5) Patients who are considered ineligible for this study by the principal investigator or collaborative doctors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| remission rate after 48 weeks | — |
Countries
Japan
Contacts
Public ContactTaku Kobayashi
Kitasato University Kitasato Institute Hospital Center for Advanced IBD Research and Treatment
Outcome results
None listed