ulcerative colitis
Conditions
Interventions
Patients in maintenance group receive intravenous infusion of infliximab (5mg/kg) at week 0, 2, and 6 and then every 8 weeks (up to week 54).
Patients in discontinuation group receive intravenous infu
Sponsors
Tohoku University Graduate School of Medicine (Tohoku University Hospital)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Eligible patients have active ulcerative colitis with a Mayo score of 6 to 12 points and moderate-to-severe active disease on sigmoidoscopy (Mayo endoscopic subscore of at least 2) despite concurrent treatment with 5-aminosalicylates, corticosteroids, azathioprine or 6-mercaptopurine at week 0, and have a clinical response to infliximab at week 8.
Exclusion criteria
Exclusion criteria: (1) Infliximab contraindication 1) Patients with severe infection (Sepsis, etc) 2) Patients with active tuberculosis 3) Patients with history of hypersensitivity to the ingredient of infliximab, 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 ever received anti-TNF antibodies before (7) Patients who have severe obstructive strictures or abdominal abscess assessed by X-ray, abdominal computed tomography, or endoscopy (8) Patients with active hepatitis B or C (9) Patients with human immunodeficiency virus (10) Patients with malignancy (11) Patients in 6 months after surgery (12) Patients judged as inadequate at the discretion of physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Remission rate at week 54 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) The rate of remission (Mayo score of 0-2, with each individual subscore of 0-1) at week 8 and 30 2) The rate of clinical response (a decrease in the total Mayo score of at least 3 points and at least 30%, with a decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore for rectal bleeding of 0 or 1) at week 8, 30 and 54 3) The rate of mucosal healing at week 8, 30 and 54 4) 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