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

Tracking Information

First Received Date ^ICMJE

May 10, 2002

Last Updated Date

August 29, 2008

Start Date ^ICMJE

February 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

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.

Change History

Complete list of historical versions of study NCT00036439 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 rectalbleeding subscore of either 0 or 1; mucosal heeling at week 8

Original Secondary Outcome Measures ^ICMJE

The proportion of patients in clinical remission defined as a Mayo score of ≤ 2 points, with noindividual subscore > 1 at week 8
Patients in remission by this definition will have a rectalbleeding subscore of either 0 or 1
The proportion of patients who demonstrate mucosal healing at week 8

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Randomized, Placebo-Controlled, Double-Blind Trial to Evaluate the Safety and Efficacy of Infliximab in Patients With Active Ulcerative Colitis

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 Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Ulcerative Colitis

Intervention ^ICMJE

Drug: Infliximab

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

360

Completion Date

August 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00036439

Responsible Party

Study ID Numbers ^ICMJE

CR004777

Study Sponsor ^ICMJE

Centocor, Inc.

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Centocor, Inc. Clinical Trial

Centocor, Inc.

Information Provided By

Centocor, Inc.

Verification Date

August 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP