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

Centocor, Inc.364 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

364

Conditions

Ulcerative Colitis

Interventions

InfliximabDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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