Ulcerative Colitis |
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Clinical Trial: Study of Infliximab for the Treatment of Patients with Active Ulcerative Colitis
This study has been completed.
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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
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:
- Have severe colitis
- Are pregnant or breast-feeding.
- Have used investigational drug within 30 days prior to screening.
- Have received previous administration of infliximab.
- Have a concomitant diagnosis of congestive heart failure (CHF).
Location Information
Minnesota
Mayo Clinic, Rochester, Minnesota, 55905, United States
Belgium
Academisch Ziekenhuis Gasthuisberg, Leuven, B-3000, Belgium
More Information
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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