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

This study has been completed.
Sponsor:
Information provided by:
Centocor, Inc.
ClinicalTrials.gov Identifier:
NCT00096655
First received: November 12, 2004
Last updated: May 16, 2011
Last verified: March 2010

November 12, 2004
May 16, 2011
May 2002
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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 .
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Complete list of historical versions of study NCT00096655 on ClinicalTrials.gov Archive Site
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.
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A Safety and Efficacy Study for Infliximab (Remicade) in Patients With Ulcerative Colitis
A Randomized, Placebo-controlled, Double-blind Trial to Evaluate the Safety and Efficacy of Infliximab in Patients With Active Ulcerative Colitis

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Ulcerative Colitis
Drug: Infliximab
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
364
August 2007
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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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
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NCT00096655
CR004783
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Centocor, Inc.
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Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.
Centocor, Inc.
March 2010

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