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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-UMIN000005761 |
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Date of registration:
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13/06/2011 |
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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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The Study for Efficacy and Safety of Adalimumab for Crohn's Disease with Loss of Response to Infliximab
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Scientific title:
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The Study for Efficacy and Safety of Adalimumab for Crohn's Disease with Loss of Response to Infliximab - The Efficacy of Adalimumab |
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Date of first enrolment:
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2010/10/27 |
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Target sample size:
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50 |
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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=R000006811 |
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Study type:
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Interventional |
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Study design:
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Single arm Non-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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Address:
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Japan |
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Telephone:
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Email:
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nkamata@med.osaka-cu.ac.jp |
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Affiliation:
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Osaka City University Gradatescool of Medicine Gastroenterology |
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Name:
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Kenji Watanabe |
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Address:
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1-4-3, Asahi-machi, Abeno-ku, Osaka
Japan |
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Telephone:
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Email:
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Affiliation:
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Osaka City University Gradatescool of Medicine Gastroenterology |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 1)The patient of contraindication for adalimumab as following a.serious infections b.active tuberculosis c.hypersensitivity d.neurologic reactions (peripheral demyelinating disease) e.congestive heart failure 2)The case which is hard to get the patient's consent 3)The patient who was judged for unsuitable by responsibility doctor
Age minimum:
Not applicable
Age maximum:
Not applicable
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Crohn's Disease patient as following 1)or 2) 1)the patient who treated with IFX infusion of interval every 4-6 weeks. 2)the patient who could not keep to treat with IFX due to side effect or ineffectiveness.
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Intervention(s)
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Adalimumab (HUMIRA 40mg for SC Injection) Inject SC 160mg on Day 1, then inject SC 80 mg on Day 15, and inject SC 40 mg every other week, beginning on Day 29.
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Primary Outcome(s)
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CDAI score in the 28th week (the rate of remission, CR70, CR100), SF-36, IBDQ
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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:
Contact:
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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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