Crohn disease
Conditions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Biologics-resistant patients against maintenance therapy of biologics
Exclusion criteria
Exclusion criteria: Non-responder for biologics Patients with small intestinal lesion and having risk of ileus Patient with fulminant Crohn disease(CD) Patient need early operation for CD Patient with active infection Patient with severe complication(s) Patient with malignancy or past history of malignancy Pregnant woman
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy change of CDAI at week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy change of CDAIat week 4 and 6 effective rate of CDAI at week 8 endoscopic evaluation (SESCD) at week 8 change of CRP at week 4 and 8 fecal immunochemical test and calprotectin at week 1 | — |
Countries
Japan