A Safety and Efficacy Study for Infliximab (Remicade) in Patients With Active Ulcerative Colitis

Phase 3

Completed

• Conditions: Ulcerative Colitis

• Registration Number: NCT00036439
• Lead Sponsor: Centocor, Inc.

Brief Summary

The purpose of this study is to evaluate the effectiveness and safety of infliximab (Remicade) in patients with Ulcerative Colitis.

Detailed Description

This is a study designed to investigate the safety and effectiveness of a medication called infliximab (the active drug in (REMICADE®) in adult patients with active ulcerative colitis. The purpose of this study is to see if the symptoms of ulcerative colitis are lessened with this medication, infliximab, and what dose is needed to do that safely. Patients will receive infusions of either 5mg/kg, 10 mg/kg or placebo at weeks 0, 2, 6, and then once every 8 weeks thereafter through week 46 for up to 3 years.

Safety evaluations will be performed at specified intervals throughout the study and will consist of laboratory tests, vital signs (such as blood pressure), physical examinations and the occurrence and severity of adverse events as well as other study specific procedures. Patients will receive infusions of either 5mg/kg, 10 mg/kg or placebo at weeks 0, 2, 6, and then once every 8 weeks thereafter through week 46 for up to 3 years.

Study Timeline

• Study Start: 2002-02
• Study First Submitted: 2002-05-10
• Study First Submitted QC: 2002-05-10
• Study First Posted: 2002-05-13
• Study Completion: 2007-01
• Status Verified: 2010-03
• Last Update Submitted: 2011-05-16
• Last Update Posted: 2011-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 364

Inclusion Criteria

• Patients who have had ulcerative colitis of at least 3 months' duration at screening
• Patients who have ulcerative colitis confirmed by the biopsy taken at screening
• Patients must have active colitis confirmed during the screening sigmoidoscopy
• Patients must have active disease.

Exclusion Criteria

• Patients must not be likely to require surgical removal of all or part of the colon within 12 weeks of beginning the study
• Patients must not require, or required within the 2 months prior to beginning the study, surgery for active gastrointestinal bleeding, peritonitis, intestinal obstruction, or intra-abdominal or pancreatic abscess requiring surgical drainage

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The proportion of patients with clinical response, defined as a decrease from baseline in the Mayo score by = 30% and = 3 points, with a decrease in the rectal bleeding subscore of = 1 or a rectal bleeding subscore of 0 or 1, at week 8.

Secondary Outcome Measures

Name	Time	Method
The proportion of patients in clinical remission defined as a Mayo score of = 2 points, with no individual subscore > 1 at week 8; Patients in remission by this definition will have a rectal bleeding subscore of either 0 or 1; mucosal heeling at week 8