A Study of Adalimumab for the Induction of Clinical Remission in Japanese Subjects With Crohn's Disease
NCT ID: NCT00445939
Last Updated: 2011-06-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
90 participants
INTERVENTIONAL
2007-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Adalimumab 160 mg/80 mg
adalimumab
160 mg at Week 0, 80 mg at Week 2
Adalimumab 80 mg/40 mg
adalimumab
80 mg at Week 0, 40 mg at Week 2
Placebo
placebo
Placebo at Week 0 and Week 2
Interventions
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adalimumab
160 mg at Week 0, 80 mg at Week 2
adalimumab
80 mg at Week 0, 40 mg at Week 2
placebo
Placebo at Week 0 and Week 2
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* If subjects have previously been administered infliximab, subjects who discontinued use due to a loss of response or intolerance to infliximab therapy
Exclusion Criteria
* History of cancer, lymphoma, leukemia or lymphoproliferative disease, active tuberculosis (TB), or Human immunodeficiency virus (HIV)
* Body weight is below 30 kg
* Surgical bowel resections within the past 6 months
* Females who are pregnant or breast-feeding or considering becoming pregnant during the study
15 Years
75 Years
ALL
No
Sponsors
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Abbott Japan Co.,Ltd
INDUSTRY
Eisai Co., Ltd.
INDUSTRY
Abbott
INDUSTRY
Responsible Party
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Abbott
Principal Investigators
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Morio Ozawa
Role: STUDY_DIRECTOR
Abbott Japan Co.,Ltd
Locations
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Aichi, , Japan
Chiba, , Japan
Ehime, , Japan
Fukuoka, , Japan
Hiroshima, , Japan
Hokkaido, , Japan
Hyōgo, , Japan
Kagawa, , Japan
Kanagawa, , Japan
Kochi, , Japan
Kyoto, , Japan
Miyagi, , Japan
Okayama, , Japan
Okinawa, , Japan
Osaka, , Japan
Shiga, , Japan
Shizuoka, , Japan
Tokyo, , Japan
Countries
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References
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Watanabe M, Hibi T, Lomax KG, Paulson SK, Chao J, Alam MS, Camez A; Study Investigators. Adalimumab for the induction and maintenance of clinical remission in Japanese patients with Crohn's disease. J Crohns Colitis. 2012 Mar;6(2):160-73. doi: 10.1016/j.crohns.2011.07.013. Epub 2011 Aug 26.
Other Identifiers
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M04-729
Identifier Type: -
Identifier Source: org_study_id
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