A Safety and Efficacy Study for Infliximab (Remicade) in Patients With Ulcerative Colitis
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|ClinicalTrials.gov Identifier: NCT00096655|
Recruitment Status : Completed
First Posted : November 15, 2004
Last Update Posted : May 17, 2011
|Condition or disease||Intervention/treatment||Phase|
|Ulcerative Colitis||Drug: Infliximab||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||364 participants|
|Intervention Model:||Parallel Assignment|
|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 Date :||May 2002|
|Actual Study Completion Date :||August 2007|
- 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 .
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00096655
|Study Director:||Centocor, Inc. Clinical Trial||Centocor, Inc.|