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A Safety and Efficacy Study for Infliximab (Remicade) in Patients With Active Ulcerative Colitis
This study has been completed.
Sponsored by: Centocor, Inc.
Information provided by: Centocor, Inc.
ClinicalTrials.gov Identifier: NCT00036439
  Purpose

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


Condition Intervention Phase
Ulcerative Colitis
Drug: Infliximab
Phase III

Genetics Home Reference related topics: Crohn disease
MedlinePlus related topics: Ulcerative Colitis
Drug Information available for: Infliximab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title: A Randomized, Placebo-Controlled, Double-Blind Trial to Evaluate the Safety and Efficacy of Infliximab in Patients With Active Ulcerative Colitis

Further study details as provided by Centocor, Inc.:

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.

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 360
Study Start Date: February 2002
Study Completion Date: August 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00036439

Sponsors and Collaborators
Centocor, Inc.
Investigators
Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.
  More Information

A Randomized, Placebo-controlled, Double-blind Trial to Evaluate the Safety and Efficacy of Infliximab in Patients with Active Ulcerative Colitis  This link exits the ClinicalTrials.gov site
/A Randomized, Placebo-controlled, Double-blind Trial to Evaluate the Safety and Efficacy of Infliximab in Patients with Active Ulcerative Coliti  This link exits the ClinicalTrials.gov site
/A Randomized, Placebo-controlled, Double-blind Trial to Evaluate the Safety and Efficacy of Infliximab in Patients with Active Ulcerative Coliti  This link exits the ClinicalTrials.gov site

Publications of Results:
Study ID Numbers: CR004777
Study First Received: May 10, 2002
Last Updated: August 29, 2008
ClinicalTrials.gov Identifier: NCT00036439  
Health Authority: United States: Food and Drug Administration

Keywords provided by Centocor, Inc.:
infliximab
Remicade
infusion
ulcerative colitis

Study placed in the following topic categories:
Digestive System Diseases
Infliximab
Gastrointestinal Diseases
Ulcer
Colonic Diseases
Inflammatory Bowel Diseases
Colitis, Ulcerative
Intestinal Diseases
Gastroenteritis
Colitis

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Pathologic Processes
Therapeutic Uses
Gastrointestinal Agents
Antirheumatic Agents
Dermatologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009