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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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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000032485 |
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Date of registration:
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08/05/2018 |
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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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efficacy of early adalimumab or immunomodulator on postoperative remission maintenance in patients with Crohn's disease
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Scientific title:
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efficacy of early adalimumab or immunomodulator on postoperative remission maintenance in patients with Crohn's disease - postoperative early adalimumab or immunomodulator in CD study |
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Date of first enrolment:
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2015/01/01 |
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Target sample size:
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20 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037045 |
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Study type:
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Interventional |
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Study design:
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Parallel Randomized
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Phase:
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Not selected
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Countries of recruitment
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Japan
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Contacts
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Name:
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Akihiro
Yamada |
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Address:
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564-1,shimoshizu, sakura,chiba
285-0841
Japan |
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Telephone:
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043-462-8811 |
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Email:
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taro-dog@sakura.med.toho-u.ac.jp |
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Affiliation:
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Sakura medical center, Toho university gastroenterology |
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Name:
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Akihiro
Yamada |
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Address:
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564-1,shimoshizu, sakura,chiba
Japan |
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Telephone:
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043-462-8811 |
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Email:
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taro-dog@sakura.med.toho-u.ac.jp |
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Affiliation:
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Sakura medical center, Toho university gastroenterology |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: stoma without intestinal resection
Age minimum:
20years-old
Age maximum:
70years-old
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Cron's disease
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Intervention(s)
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adalimumab
azathiopurine
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Primary Outcome(s)
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endoscopic remission rate of 18 months after surgery
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Secondary Outcome(s)
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clinical remission rate, negative CRP, trough level of anti-TNF agents, maintenance rate of the therapy, re-surgery rate of 18 months after surgery
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Source(s) of Monetary Support
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none
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Ethics review
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Status: YES
Approval date: 01/05/2015
Contact:
taro-dog@sakura.med.toho-u.ac.jp
Sakura medical center, Toho university
043-462-8811
taro-dog@sakura.med.toho-u.ac.jp
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