Crohn'
Conditions
Interventions
Non-infliximab arm: Conventional medicine is administered, excluding Infliximab, Azathioprine, and 6-Mercaptopurine, to subjects during the study period (for 60 months, maximum).
Infliximab arm: I
Sponsors
Lower GI disease, Hyogo College of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. A patient who is diagnosed as Crohn's disease (ilititis, colitis, or ileocolitis type). 2. A patient who has the first intestinal resection within 8weeks prior to enroll this trial. 3. A patient who has not been given any immunomodulator(s), such as Azathioprine, 6-Mercaptopurine, within 8 weeks prior to enroll the trial. 4. A patient who has judged not to have other active CD lesion(s) expects the rejected lesion by either just before or during the operation. (judged by a doctor in charge) 5. A patient who is 16 to 64 years old and has written his (her) signature to a document for agreement (If a patient is under 20 years old, a signature of his (her) legal representative is necessary).
Exclusion criteria
Exclusion criteria: 1. A patient who has had hypersensitivity to infliximab. 2. A patient who has had a surgery for anal lesion (without intestinal resection) as a reason to be involved for this trial. 3. A patient who has abscess lesion(s). 4. A patient who has past and/or present episode of tuberoses infection. 5. A patient who is determined as ineligible for a subject in this study by a doctor in charge or others.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of efficiency: Remission ratios at 24 months (and 60 months, maximum) after start of protocol treatment, Ratio of the protocol continuation, Clinical activity in both the CDAI and IOIBD, IBDQ score, CRP value, etc. Evaluation of safety: Adverse event, Abnormal values in blood test, etc. | — |
Primary
| Measure | Time frame |
|---|---|
| Remission rate at 12 months after the start of protocol treatment (Full Analysis Set; Discontinuation of protocol treatment is accounted to be non-remission.) | — |
Countries
Japan
Contacts
Public ContactKen Fukunaga
Hyogo College of Medicine Lower GI disease
Outcome results
None listed