ulcerative colitis
Conditions
Interventions
Patients in Infliximab monotherapy receive intravenous infusion of IFX at week 0, 2, and 6, and then every 8 weeks (up to week 54).
Patients in the combination therapy of Infliximab and azathiopurine
Sponsors
Department of Gastroenterology and Hepatology, Kyoto University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with moderately active ulcerative colitis (CAI; 7-11) 2) Patients treated with corticosteroid (PSL; less or equal to 30mg/day, within 2 weeks) 3) Immunomodulators (azathiopurine, methotrexate, tacrolimus, cyclosporine ) naive patients 4) Anti-TNF biologic agent naive patients
Exclusion criteria
Exclusion criteria: 1) Patients who are required total colectomy or subtotal colectomy 2) Patients with severe active ulcerative colitis (CAI; more than 12) 3) Patients with malignancy 4) Patients with intestinal stenosis to cause intestinal obstruction 5) Patients with serious extraintestinal complication 6) Patients who are pregnant or desire pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Remission and clinical response rate at week 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Remission rate (CAI 0-4) at week 8, 30, and 54 2) Clinical response (more than 50 percent reduction from baseline in their CAI) at week 8 and 54 3) Mucosal healing at week 8 and 54 4) Steroid sparing effect 5) Safety assessment | — |
Countries
Japan
Contacts
Public ContactMinoru Matsuura
Kyoto University Hospital Department of Gastroenterology and Hepatology
Outcome results
None listed