Conventional Step-Up Versus Infliximab Monotherapy in Patients With Ulcerative Colitis (P05553)
Status:
Terminated
Trial end date:
2012-03-01
Target enrollment:
Participant gender:
Summary
This study will be performed to compare the efficacy and safety of the classical "Step-Up"
approach for treatment of moderate-to-severe active ulcerative colitis using oral
prednisolone + oral 5-aminosalicylic acid (5-ASA) or oral prednisolone + oral azathioprine
(AZA) with a more intensive and early "Top-Hold" approach with intravenous infliximab (5
mg/kg) administered at Weeks 0, 2, and 6 and 8 weeks thereafter.