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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

November 12, 2004

Last Updated Date

August 21, 2008

Start Date ^†

May 2002

Current Primary Outcome Measures ^†

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 ^†

Same as current

Change History

Complete list of historical versions of study NCT00096655 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Achievement of clinical remission defined as a Mayo score of = 2 points, with no individual subscore > 1 at week ,Patients in remission will have a rectalbleeding subscore of either 0 or 1, patients who demonstrate mucosal healing at week 8.

Original Secondary Outcome Measures ^†

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 ^†

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

Official Title ^†

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. Infliximab (Remicade) targets specific proteins in the body's immune system to help control the development of inflammation to help reduce painful disease.

Detailed Description

This study is designed to investigate the safety and effectiveness of infliximab 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 5 or 10 mg/kg or placebo at weeks 0, 2, 6, 14, and 22 up to week 164. 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 (into the vein) of either 5 or 10 mg/kg or placebo at weeks 0, 2, 6, and every 8 weeks up to week 164.

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

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

Condition ^†

Ulcerative Colitis

Intervention ^†

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 ^†

Completed

Estimated Enrollment ^†

360

Completion Date

August 2007

Primary Completion Date

Eligibility Criteria ^†

Inclusion Criteria:

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

Exclusion Criteria:

Patient must not be likely to require surgical removal of all or part of the colon within 12 weeks of beginning the study
Patient 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

Yes

Contacts ^††

Location Countries ^†

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00096655

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Centocor, Inc.

Collaborators ^††

Investigators ^†

Study Director:

Centocor, Inc. Clinical Trial

Centocor, Inc.

Information Provided By

Centocor, Inc.

Verification Date

August 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.