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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-UMIN000009596 |
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Date of registration:
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21/12/2012 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Withdrawal of immunomodulator in Crohn's disease treated with adalimumab and immnomodulator : a multicenter randomized trial(Diamond2 study).
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Scientific title:
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Withdrawal of immunomodulator in Crohn's disease treated with adalimumab and immnomodulator : a multicenter randomized trial(Diamond2 study). - Withdrawal of immunomodulator in Crohn's disease treated with adalimumab and immnomodulator : a multicenter randomized trial. |
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Date of first enrolment:
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2013/01/01 |
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Target sample size:
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200 |
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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=R000011255 |
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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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Tadakazu Hisamatsu |
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Address:
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Shinanomachi 35, Shinjyuku-ku, Tokyo
Japan |
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Telephone:
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03-3353-1211 |
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Email:
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hisamachi@a7.keio.jp |
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Affiliation:
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School of Medicine, Keio University Gastroenterology |
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Name:
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Toshifumi Hibi |
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Address:
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Shinanomachi 35, Shinjyuku-ku, Tokyo
Japan |
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Telephone:
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03-3353-1211 |
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Email:
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thibi@z5.keio.jp |
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Affiliation:
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School of Medicine, Keio University Gastroenterology |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 1. The patient is below 15 years of age 2. The patient is pregnant or lactating 3. The patient has an artificial anus 4. The period after the patient underwent gastrointestinal surgery is within 6 months 5. The patient has short-bowel syndrome 6. The patient has an imminent CD-related surgery 7. The patient has malignant tumor 8. The patient was judged not eligible by the investigator.
Age minimum:
15years-old
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
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Intervention(s)
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Withdrawal of the concomitant immunomodulator (azathioprine or 6-mercaptoprine) while under adalimumab 40 mg/every other week continued treatment.
Non-withdrawal of the concomitant immunomodulator (azathioprine or 6-mercaptoprine) while under adalimumab 40 mg/every other week continued treatment.
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Primary Outcome(s)
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Remission maintenance rate (nonclinical relapse rate) following a steroid-free period of 52 weeks. *Clinical relapse: The condition where CDAI increased at least 70%, and is at least 150.
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Secondary Outcome(s)
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Endoscopic relapse rate *Endoscopic relapse: ulcer findings present CRP negative rate *CRP positive: CRP is at least 0.3 mg/dL Steroid-free remission maintenance rate by factor (duration of illness, IFX treatment history, CRP, endoscopic findings etc.) Incidence of adverse events etc.
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Source(s) of Monetary Support
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Department of Internal Medicine(Gastroenterology), School of Medicine, Keio University and Self funding of each Institusions
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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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Yes |
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Date Posted:
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Date Completed:
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31/12/2015 |
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URL:
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