The study of the effectiveness of maintenance treatment with infliximab for ulcerative colitis patients who respond to induction treatment with infliximab

Authors
Category Primary study
Registry of TrialsUMIN Clinical Trials Registry
Year 2012
INTERVENTION: 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 infusion of infliximab (5mg/kg) at week 0, 2, and 6 (not receiving infliximab at week 14, 22, 30, 38, 46 and 54). CONDITION: ulcerative colitis PRIMARY OUTCOME: Remission rate at week 54 SECONDARY OUTCOME: 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. 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.
Epistemonikos ID: 535335637362324c561205c7bc2b6c14e308b050
First added on: Aug 22, 2024