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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00036439 |
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Date of registration:
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10/05/2002 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Safety and Efficacy Study for Infliximab (Remicade) in Patients With Active Ulcerative Colitis
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Scientific title:
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A Randomized, Placebo-controlled, Double-blind Trial to Evaluate the Safety and Efficacy of Infliximab in Patients With Active Ulcerative Colitis |
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Date of first enrolment:
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February 2002 |
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Target sample size:
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364 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00036439 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Belgium
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United States
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Contacts
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Name:
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Centocor, Inc. Clinical Trial |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centocor, Inc. |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients who have had ulcerative colitis of at least 3 months' duration at screening
- Patients who have ulcerative colitis confirmed by the biopsy taken at screening
- Patients must have active colitis confirmed during the screening sigmoidoscopy
- Patients must have active disease.
Exclusion Criteria:
- Patients must not be likely to require surgical removal of all or part of the colon
within 12 weeks of beginning the study
- Patients 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Ulcerative Colitis
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Intervention(s)
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Drug: Infliximab
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Primary Outcome(s)
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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.
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Secondary Outcome(s)
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The proportion of patients in clinical remission defined as a Mayo score of = 2 points, with no individual subscore > 1 at week 8; Patients in remission by this definition will have a rectal bleeding subscore of either 0 or 1; mucosal heeling at week 8
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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