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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-UMIN000030988 |
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Date of registration:
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01/02/2018 |
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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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Open-label, randomized, two-parallel-arm, single center study to designed to evaluate azathioprine versus adalimumab after induction of tacrolimus in refractory ulcerative colitis therapy
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Scientific title:
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Open-label, randomized, two-parallel-arm, single center study to designed to evaluate azathioprine versus adalimumab after induction of tacrolimus in refractory ulcerative colitis therapy - Comparison of maintenance treatment between azathioprine and adalimumab after induction of tacrolimus in ulcerative colitis therapy (CAT study) |
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Date of first enrolment:
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2018/02/01 |
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Target sample size:
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53 |
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Recruitment status: |
Pending |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035381 |
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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 applicable
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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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Yasuo Suzuki |
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Address:
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564-1, Shimoshizu, Sakura, Chica
Japan |
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Telephone:
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043-462-8811 |
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Email:
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yasuo-suzuki@sakura.med.toho-u.ac.jp |
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Affiliation:
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Sakura Medical Center, Toho university Inflammatory bowel disease (IBD) center |
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Name:
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Yasuo Suzuki |
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Address:
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564-1, Shimoshizu, Sakura, Chica
Japan |
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Telephone:
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043-462-8811 |
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Email:
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yasuo-suzuki@sakura.med.toho-u.ac.jp |
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Affiliation:
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Sakura Medical Center, Toho university Inflammatory bowel disease (IBD) center |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: Patients who are contraindicated of tacrolimus, azathioprine or adalimumab Female patients who are in lactation or desire to bear children Patients less than 15 years old Patients who do not consent to the trial Patients who had malignancy Patients who had intestinal resection within 6 months Patients who are short-bowel syndrome Patients who are not appropriate to participate to the trial
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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Ulcerative Colitis
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Intervention(s)
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Induce azathioprine and continue maintenance therapy by azathioprine
Induce adalimumab and continue maintenance therapy by adalimumab
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Primary Outcome(s)
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Comparison of non-relapse rates (1 year) between azathioprine group and adalimumab group
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Secondary Outcome(s)
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Comparison of side-effect rates (1 year) between azathioprine group and adalimumab group Comparison of clinical remission rates (1 year) between azathioprine group and adalimumab group Comparison of endoscopic remission rates (1 year) between azathioprine group and adalimumab group
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Source(s) of Monetary Support
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Sakura Medical Center, Toho university
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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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