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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-UMIN000006141 |
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Date of registration:
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12/08/2011 |
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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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Comparative study of Infliximab monotherapy vs combined therapy with azathiopurine for inducing and maintaining clinical remission in steroid-dependent or -resistant ulcerative colitis
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Scientific title:
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Comparative study of Infliximab monotherapy vs combined therapy with azathiopurine for inducing and maintaining clinical remission in steroid-dependent or -resistant ulcerative colitis - Comparative study of Infliximab monotherapy vs combined therapy with azathiopurine for inducing and maintaining clinical remission in steroid-dependent or -resistant ulcerative colitis |
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Date of first enrolment:
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2011/10/01 |
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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=R000007262 |
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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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Minoru Matsuura |
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Address:
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54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, 606-8507, Japan
Japan |
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Telephone:
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075-751-4319 |
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Email:
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minomats@kuhp.kyoto-u.ac.jp |
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Affiliation:
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Kyoto University Hospital Department of Gastroenterology and Hepatology |
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Name:
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Hiroshi Nakase |
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Address:
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54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, 606-8507, Japan
Japan |
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Telephone:
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075-751-4319 |
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Email:
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hiropy_n@kuhp.kyoto-u.ac.jp |
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Affiliation:
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Kyoto University Hospital Division of Endoscopic Medicine |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 1) Patients who are required total colectomy or subtotal colectomy 2) Patients with severe active ulcerative colitis (CAI; more than 12) 3) Patients with malignancy 4) Patients with intestinal stenosis to cause intestinal obstruction 5) Patients with serious extraintestinal complication 6) Patients who are pregnant or desire pregnancy
Age minimum:
16years-old
Age maximum:
75years-old
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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Patients in Infliximab monotherapy receive intravenous infusion of IFX at week 0, 2, and 6, and then every 8 weeks (up to week 54).
Patients in the combination therapy of Infliximab and azathiopurine receive intravenous infusion of IFX (at week 0, 2, 6, and then every 8 weeks) and oral azathiopurine (up to week 54).
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Primary Outcome(s)
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Remission and clinical response rate at week 30
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Secondary Outcome(s)
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1) Remission rate (CAI 0-4) at week 8, 30, and 54 2) Clinical response (more than 50 percent reduction from baseline in their CAI) at week 8 and 54 3) Mucosal healing at week 8 and 54 4) Steroid sparing effect 5) Safety assessment
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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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Yes |
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Date Posted:
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Date Completed:
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01/12/2014 |
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URL:
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