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Study of Infliximab for the Treatment of Patients with Active Ulcerative Colitis - Article


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Infliximab

Remicade



Clinical Trial: Study of Infliximab for the Treatment of Patients with Active Ulcerative Colitis

This study has been completed.

Sponsored by: Centocor
Information provided by: Centocor

Purpose

A research study to evaluate the safety and effectiveness of an investigational drug is currently being conducted in adults with moderate to severe ulcerative colitis. The aim of the international study is to evaluate the efficacy and safety of Infliximab in patients with active ulcerative colitis. The study is being conducted in the US, Canada, Denmark, Spain, UK, Belgium and Germany.

Condition Treatment or Intervention Phase
Ulcerative Colitis
 Drug: Infliximab
Phase III

MedlinePlus related topics:  Ulcerative Colitis

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, 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: 

Study start: March 2002

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria

Patients may be eligible for this study if they:

  • Have had ulcerative colitis of at least 3 months duration.
  • Have active disease
  • Are at least 18 years old.
  • Agree to use a barrier method of birth control during the study.

Exclusion Criteria

Patients will not be eligible for this study if they:


Location Information


Minnesota
      Mayo Clinic, Rochester,  Minnesota,  55905,  United States

Belgium
      Academisch Ziekenhuis Gasthuisberg, Leuven,  B-3000,  Belgium

More Information

Study ID Numbers:  CO168T37
Record last reviewed:  November 2004
Last Updated:  November 9, 2004
Record first received:  May 10, 2002
ClinicalTrials.gov Identifier:  NCT00036439
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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November 18, 2008



Page Updated: June 1, 2005
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