Active Crohn's Disease
Conditions
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: * Primary lesion in either small intestine or large intestine * C-reactive protein (CRP) level above the upper limit of the normal range * Patients who have been receiving a 5-ASA formulation (oral mesalazine) at a fixed dose of 2.25 g/day or higher (not exceeding the approved dose) and at a fixed dosing regimen * Patients who have not received enteral nutrition or who have been receiving enteral nutrition at a fixed intake of 1200 kcal/day or less
Exclusion criteria
Exclusion criteria: * Patients with an uncontrolled external fistula (including anal fistula) * Patients with a history of total proctocolectomy or subtotal colectomy * Patients with short bowel syndrome * Patients with an artificial anus * Patients with serious infectious disease (intra-abdominal abscess, etc) * Patients with malignant tumor * Female patients who are pregnant, lactating, or possibly pregnant, or who wish to become pregnant during the trial period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Clinical improvement rate after 8 weeks number of subjects showing clinical improvement / number of subjects evaluated x 100 | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy Clinical improvement rate after 4 weeks efficacy Remission rate after 4, 8 weeks efficacy CRP after 4, 8 weeks mean change in CRP level from the baseline | — |
Countries
Asia except Japan, Japan
Outcome results
None listed