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

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ClinicalTrials.gov Identifier: NCT00096655
Recruitment Status : Completed
First Posted : November 15, 2004
Last Update Posted : May 17, 2011
Sponsor:
Information provided by:
Centocor, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: Infliximab Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 364 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-controlled, Double-blind Trial to Evaluate the Safety and Efficacy of Infliximab in Patients With Active Ulcerative Colitis
Study Start Date : May 2002
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Infliximab

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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 rectal bleeding subscore of either 0 or 1, patients who demonstrate mucosal healing at week 8.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00096655


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00096655     History of Changes
Other Study ID Numbers: CR004783
First Posted: November 15, 2004    Key Record Dates
Last Update Posted: May 17, 2011
Last Verified: March 2010
Keywords provided by Centocor, Inc.:
Ulcerative colitis
Infliximab
Remicade
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
 Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Infliximab
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents