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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-UMIN000012469 |
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Date of registration:
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02/12/2013 |
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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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Comparison of Adalimumab and Steroid in Intestinal Behcet's disease
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Scientific title:
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Comparison of Adalimumab and Steroid in Intestinal Behcet's disease - Castle Study |
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Date of first enrolment:
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2013/12/02 |
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Target sample size:
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50 |
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Recruitment status: |
Recruiting |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014594 |
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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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Kenji
Watanabe |
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Address:
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1-4-3, Asahi-machi, Abeno-ku, Osaka
Japan |
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Telephone:
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06-6645-3811 |
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Email:
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kenjiw@med.osaka-cu.ac.jp |
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Affiliation:
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Osaka City University Department of Gastroenterology |
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Name:
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Kenji
Watanabe |
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Address:
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1-4-3, Asahi-machi, Abeno-ku, Osaka
545-8585
Japan |
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Telephone:
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06-6645-3811 |
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Email:
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kenjiw@med.osaka-cu.ac.jp |
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Affiliation:
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Osaka City University Department of Gastroenterology |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 1) The patients with simple ulcer disease complicated without general Behcet's symptoms 2) Contraindication of adalimumab administration a: Severe infectious disease b: Active tuberculosis c: Past history for hypersensitivity of adalimumab contents d: Present or past history for demyelinating disorder e: Congestive heart failure 3) Contraindication for steroid administration a: Past history for hypersensitivity of prednisolone contents 4) Pregnant or breast feeding woman 5) Below the age of 15 years old 6) The patients who are unable to provide informed consent 7) The patients who are begun to administrate with more than 10mg/kg steroid within 2 weeks 8) The patients who are administrated with steroid more than 2 weeks 9) The patients who had been administrated with infliximab or adalimumab. However, the patients who were intolerant for infliximab within 2nd infusion (0 week or 2 weeks) can be enrolled. 10) The patients who are added or increased dosage of administration with as follows, 5-aminosalicylates or nutrition therapy within 2 weeks, colchicine or tacrolimus or ciclosporin or methotrexate within 4 weeks, azathioprine or 6-mercaptopurine within 8 weeks 11) Malignancy patient 12) The patients who are contained with untypical lesion for intestinal Behcet's disease 13) The patients who are indicated as insufficient by the physician
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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Intestinal Behcet's disease
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Intervention(s)
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Subcutaneous injection of adalumumab with 160mg at 0 week, 80mg at 2 weeks and 40mg every other week after at 4 weeks continuously.
Oral administration of prednisolone with 0.6mg/kg/day during from 1 to 2 weeks, and tapering off until 12 weeks with decreasing dosage 5mg/kg/week approximately
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Primary Outcome(s)
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Endoscopic efficacy at 12 weeks
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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: 03/10/2013
Contact:
ethics@med.osaka-cu.ac.jp
Osaka City University Hospital Certified Review Board
06-6645-3435
ethics@med.osaka-cu.ac.jp
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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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31/12/2025 |
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URL:
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