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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-UMIN000019066 |
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Date of registration:
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18/09/2015 |
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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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An open label randomized controlled trial of combination therapy of Adalimumab and GMA for intractable ulcerative colitis
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Scientific title:
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An open label randomized controlled trial of combination therapy of Adalimumab and GMA for intractable ulcerative colitis - An open label randomized controlled trial of combination therapy of Adalimumab and GMA for intractable ulcerative colitis |
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Date of first enrolment:
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2015/09/25 |
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Target sample size:
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58 |
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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=R000022048 |
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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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Ken Takeuchi |
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Address:
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564-1,Shimoshizu,Sakura-city,Chiba
Japan |
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Telephone:
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043-462-8811 |
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Email:
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ken.takeuchi@sakura.med.toho-u.ac.jp |
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Affiliation:
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Sakura Medical center, Toho University Internal Medicine |
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Name:
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Ken Takeuchi |
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Address:
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564-1,Shimoshizu,Sakura-city,Chiba
Japan |
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Telephone:
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043-462-8811 |
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Email:
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ken.takeuchi@sakura.med.toho-u.ac.jp |
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Affiliation:
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Sakura Medical center, Toho University Internal Medicine |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: Adalimumab contraindication 1)Patients with severe infection (Sepsis, etc) 2)Patients with active tuberculosis 3)Patients with history of hypersensitivity to any of the other ingredients of Adalimumab 4)Patients with demyelinating disease (Multiple sclerosis, etc) or with history of demyelinating disease 5)Patients with congestive heart failure GMA contraindication 1)Granulocyte count is equal to or less than 2000/ mm3 2)Serious infectious disease
Age minimum:
20years-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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Administration of Adalimumab 160 mg at baseline, 80 mg at 2 weeks and 40 mg every 2 weeks.
In addition to Adalimumab Therapy, co-treatment of GMA 3times a week up to 2 weeks
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Primary Outcome(s)
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Partial Mayo score remission rate at week 8
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Secondary Outcome(s)
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Partial Mayo score response rate, endoscopic remission at week 8 Partial Mayo score remission, response rate at week 2,4,6,52 Safety until week 52
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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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