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Tracking Information | |||||
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First Received Date † | November 12, 2004 | ||||
Last Updated Date | August 21, 2008 | ||||
Start Date † | May 2002 | ||||
Current Primary Outcome Measures † |
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 † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00096655 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
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 rectalbleeding subscore of either 0 or 1, patients who demonstrate mucosal healing at week 8. | ||||
Original Secondary Outcome Measures † |
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Descriptive Information | |||||
Brief Title † | A Safety and Efficacy Study for Infliximab (Remicade) in Patients With Ulcerative Colitis | ||||
Official Title † | 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. Infliximab (Remicade) targets specific proteins in the body's immune system to help control the development of inflammation to help reduce painful disease. |
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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. |
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Study Phase | Phase III | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study | ||||
Condition † | Ulcerative Colitis | ||||
Intervention † | Drug: Infliximab | ||||
Study Arms / Comparison Groups | |||||
Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Estimated Enrollment † | 360 | ||||
Completion Date | August 2007 | ||||
Primary Completion Date | |||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts †† | |||||
Location Countries † | |||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00096655 | ||||
Responsible Party | |||||
Secondary IDs †† | |||||
Study Sponsor † | Centocor, Inc. | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | Centocor, Inc. | ||||
Verification Date | August 2008 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |