A Safety and Efficacy Study for Infliximab (Remicade) in Patients With Ulcerative Colitis
Information source: Centocor, Inc.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Ulcerative Colitis
Intervention: Infliximab (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Centocor, Inc. Official(s) and/or principal investigator(s):
Centocor, Inc. Clinical Trial, Study Director, Affiliation: Centocor, Inc.
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.
Clinical Details
Official title: A Randomized, Placebo-Controlled, Double-Blind Trial to Evaluate the Safety and Efficacy of Infliximab in Patients With Active Ulcerative Colitis
Study design: Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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 .
Secondary outcome: 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.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Additional Information
A Randomized, Placebo-controlled, Double-blind Trial to Evaluate the Safety and Efficacy of Infliximab in Patients with Active Ulcerative Colitis A Randomized, Placebo-controlled, Double-blind Trial to Evaluate the Safety and Efficacy of Infliximab in Patients with Active Ulcerative Colitis
Starting date: May 2002
Ending date: January 2007
Last updated: March 24, 2008
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