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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-UMIN000007514 |
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Date of registration:
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15/03/2012 |
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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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Phase ll Study of Postoperative Adalimumab Maintenance Therapy for Crohn's Disease Recurrence
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Scientific title:
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Phase ll Study of Postoperative Adalimumab Maintenance Therapy for Crohn's Disease Recurrence - PAD study |
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Date of first enrolment:
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2012/01/01 |
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Target sample size:
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25 |
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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=R000007915 |
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Study type:
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Interventional |
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Study design:
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Single arm Non-randomized
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Phase:
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Phase II
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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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Norifumi Hattori |
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Address:
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65 Tsurumai, Showa-ku, Nagoya
Japan |
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Telephone:
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(81)52-744-2250 |
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Email:
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norifumi@med.nagoya-u.ac.jp |
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Affiliation:
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Nagoya University Gradeate School of Medicine Department of Gastroenterology |
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Name:
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Goro Nakayama |
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Address:
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65, Tsurumai-cho, Showa-ku, Nagoya- city, Aichi-prefecture
Japan |
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Telephone:
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(81)52-744-2250 |
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Email:
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goro@med.nagoya-u.ac.jp |
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Affiliation:
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Nagoya University Gradeate School of Medicine Department of Gastroenterology |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: (1) Uncontrolled infection (2) Confirmed opportunistic infection diseases within 6 months (3) Tuberculosis or a history of it (4) most positive tuberculin skin test (5) Active hepatitis B, C or a history of hepatitis C (6) Confirmed HIV infection (7) Demyelinating disease or a history of it (8) History of lymphoproliferative disorder, or suspicion of lymphoproliferative disorder or splenomegaly (9) Lupus syndrome, and positive anti-dsDNA antibody (10) malignant tumor (11) Clinically abnormal electrocardiogram or cardiovascular disease. (12) Severe pulmonary disease (13) Interstitial pneumonia or pulmonary fibrosis or a history of those (14) Severe hepatic disease (15) Severe renal failure (16) Severe drug allergies (17) Bowel obstraction or bowel paresis (18) Severe or uncontrollable complications (diabetes mellitus, hypertention, diarrhea, electrolyte abnormality, etc.) (19) Psychiatric disorder, central nervous system damage, cerebrovascular diseases (20) Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers. (21) Not appropriate for the study at the physician's assessment.
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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Crohn's disease
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Intervention(s)
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Adalimumab (HUMIRA 40mg for SC Injection) Inject SC 160mg on Day 1, then inject SC 80 mg on Day 15, and inject SC 40 mg every other week, beginning on Day 29.
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Primary Outcome(s)
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Endoscopic recurrence rete at the anastomotic site after 1 year.
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Secondary Outcome(s)
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Endoscopic recurrence rete at the anastomotic site Clinical Recurrence rate Crohn's disease activity index point (CDAI) Recurrence-free survival time. Time to treatment failure. Rate of adverse event
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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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01/01/2019 |
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URL:
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