A Study of the Safety and Efficacy of Infliximab (Remicade) in Subjects With Fistulizing Crohn's Disease
NCT ID: NCT00207766
Last Updated: 2010-04-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
306 participants
INTERVENTIONAL
2000-06-30
2006-08-31
Brief Summary
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Detailed Description
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Subjects will receive infliximab at weeks 0, 2 and 6 followed by infusions of infliximab 5 mg/kg or placebo at weeks 14 and every 8 weeks until week 46. Patients who lose response are eligible for increasing treatment by 5 mg/kg of infliximab.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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infliximab or placebo
Eligibility Criteria
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Inclusion Criteria
* Crohn's disease of at least 3 months' duration,
Exclusion Criteria
* Positive stool culture
18 Years
ALL
No
Sponsors
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Centocor, Inc.
INDUSTRY
Principal Investigators
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Centocor, Inc. Clinical Trial
Role: STUDY_DIRECTOR
Centocor, Inc.
References
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Sands BE, Blank MA, Patel K, van Deventer SJ; ACCENT II Study. Long-term treatment of rectovaginal fistulas in Crohn's disease: response to infliximab in the ACCENT II Study. Clin Gastroenterol Hepatol. 2004 Oct;2(10):912-20. doi: 10.1016/s1542-3565(04)00414-8.
Sands BE, Anderson FH, Bernstein CN, Chey WY, Feagan BG, Fedorak RN, Kamm MA, Korzenik JR, Lashner BA, Onken JE, Rachmilewitz D, Rutgeerts P, Wild G, Wolf DC, Marsters PA, Travers SB, Blank MA, van Deventer SJ. Infliximab maintenance therapy for fistulizing Crohn's disease. N Engl J Med. 2004 Feb 26;350(9):876-85. doi: 10.1056/NEJMoa030815.
Other Identifiers
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CR005413
Identifier Type: -
Identifier Source: org_study_id
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