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Conventional Step-Up Versus Infliximab Monotherapy in Patients With Ulcerative Colitis (Study P05553)

2014-08-27 03:19:04 | BioPortfolio

Summary

This study will be performed to directly compare the efficacy and safety of the classical "Step-Up" approach for treatment of moderate to severe active ulcerative colitis using prednisolone and 5-aminosalicylic acid (5-ASA) and oral Azathioprine (AZA) with a more intensive and early "Top-Hold" approach with infliximab (5 mg/kg) continuously given every 8 weeks following induction at weeks 0, 2, and 6.

Investigational Medical Product: Infliximab at 5 mg/kg body weight intravenously (IV) for induction and maintenance treatment given at week 0,2,6, followed by q8w (Level 1) and q4w (Level 2) weeks through week 46. Non responders in Level 2 will be switched to prednisolone combined with AZA (oral Azathioprine) (Level 3).

Reference Products: Level 1: Oral prednisolone (40 mg/day or 1mg/kg/day in case of non-response) and oral 5-ASA (2 g/day); Level 2: Oral prednisolone (40 mg/day or 1 mg/kg/day in case of non-response) and oral AZA at a dose of 2.0 - 2.5 mg/kg/day. Non-responders in Level 2 will enter Level 3: Infliximab at 5 mg/kg. The reference therapy in Levels 1 and 2 will be administered daily up to week 50, or in Level 3 infliximab q8w through week 46.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Colitis, Ulcerative

Intervention

Infliximab, Prednisolone, 5-aminosalicylic acid (5-ASA), Azathioprine (AZA)

Location

Investigational Site 44
Amberg
Germany
92224

Status

Recruiting

Source

Schering-Plough

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:19:04-0400

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