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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-UMIN000007047 |
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Date of registration:
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10/01/2012 |
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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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Effect of adacolumn and adalimumab combination therapy for the active stage Crohn's disease
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Scientific title:
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Effect of adacolumn and adalimumab combination therapy for the active stage Crohn's disease - Effect of adacolumn and adalimumab combination therapy for Crohn's disease |
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Date of first enrolment:
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2011/11/01 |
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Target sample size:
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40 |
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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=R000008194 |
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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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Shinichi Hashimoto |
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Address:
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1-1-1 Minami-Kogushi, Ube, Yamaguchi
Japan |
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Telephone:
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0836-22-2241 |
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Email:
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Affiliation:
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Yamaguchi University Graduate School of Medicine Department of Gastroenterology and Hepatology |
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Name:
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Shinichi Hashimoto |
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Address:
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1-1-1 Minami-Kogushi, Ube, Yamaguchi
Japan |
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Telephone:
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0836-22-2241 |
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Email:
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has-333@yamaguchi-u.ac.jp |
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Affiliation:
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Yamaguchi University Graduate School of Medicine Department of Gastroenterology and Hepatology |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: Below 2,000 / mm3 granulocyte count Severe infection Severe heart disease Severe Renal disease Systolic blood pressure less than 80mmHg patient with suspected or currently pregnant Increased intensity of extreme dehydration or coagulation system Severe anemia Malignant tumor Short-bowel syndrome Artificial anus External fistula Ileus or svere stenosis of the intestine Extraintestinal complications Recent use of steroid, 5-Aminosalicylic acid, immunomodulator, biologics, elemental diet Recent operation
Age minimum:
12years-old
Age maximum:
75years-old
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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Adacolumn and adalimumab combination therapy for 10 weeks. Adalimumab single therapy for remain 94 weeks.
Adacolumn single therapy for 104 weeks.
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Primary Outcome(s)
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Remission induction rate 11 weeks after the start of therapy. Remission rate 104 weeks after the start of therapy.
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Secondary Outcome(s)
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Remission period CT or CT enteroclysis/enterography Change of the CRP Safety
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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: 26/10/2011
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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01/12/2015 |
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URL:
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