Crohn'
Conditions
Interventions
Patients in monotherapy group receive
1) intravenous infusion of infliximab (10mg/kg) at every 8 weeks (dose escalation of anti-TNF antibody), or 2) intravenous infusion of infliximab (5mg/kg) at week 0, 2, and 6 and then every 8 weeks, o
Sponsors
Tohoku University Graduate School of Medicine (Tohoku University Hospital)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Eligible patients have active Crohn's disease with a CDAI score of 220 to 450 points, and have a clinical response to anti-TNF antibody with a CDAI score of less than 220 at week 8. This study is especially aimed at the patients who require dose escalation of 1st anti-TNF antibody or switch to 2nd anti-TNF antibody, after loss of response and/or intolerance to 1st anti-TNF antibody.
Exclusion criteria
Exclusion criteria: (1) anti-TNF antibody contraindication 1) Patients with severe infection (Sepsis, etc) 2) Patients with active tuberculosis 3) Patients with history of hypersensitivity to the ingredient of anti-TNF antibody, or the protein of mouse origin 4) Patients with demyelinating disease (Multiple sclerosis, etc) or with history of demyelinating disease 5) Patients with congestive heart failure (2) Pregnant or likely to be pregnant women (3) Pregnant or lactating women (4) Patients < 20 years of age (5) Patients not approving the study consent (6) Patients who have severe obstructive strictures or abdominal abscess assessed by X-ray, abdominal computed tomography, or endoscopy (7) Patients with active hepatitis B or C (8) Patients with human immunodeficiency virus (9) Patients with malignancy (10) Patients judged as inadequate at the discretion of physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The occurrence of relapse (Relapse was defined as either the increase of CDAI score of more than 70 points compared with the score at week 8, or the need for therapy to induce remission.) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) The rate of clinical response (CDAI score of less than 220) at week 8 2) The rate of mucosal healing at week 24 and 48 3) Safety assessment etc. | — |
Countries
Japan
Contacts
Public ContactHisashi Shiga
Tohoku University Graduate School of Medicine (Tohoku University Hospital) Division of Gastroenterology
Outcome results
None listed