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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00036439
Recruitment Status : Completed
First Posted : May 13, 2002
Last Update Posted : May 17, 2011
Sponsor:
Information provided by:
Centocor, Inc.

Tracking Information
First Submitted Date  ICMJE May 10, 2002
First Posted Date  ICMJE May 13, 2002
Last Update Posted Date May 17, 2011
Study Start Date  ICMJE February 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: March 6, 2008)
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 Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 29, 2010)
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
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Ulcerative Colitis
Intervention  ICMJE Drug: Infliximab
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 25, 2010)
364
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE January 2007
Primary Completion Date Not Provided
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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Belgium,   United States
 
Administrative Information
NCT Number  ICMJE NCT00036439
Other Study ID Numbers  ICMJE CR004777
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Centocor, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.
PRS Account Centocor, Inc.
Verification Date March 2010

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