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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-UMIN000019958 |
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Date of registration:
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27/11/2015 |
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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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Research for biomarkers of inflammatory bowel disease. - Investigation of the usefulness of LRG for evaluation of disease condition after adalimumab treatments
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Scientific title:
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Research for biomarkers of inflammatory bowel disease. - Investigation of the usefulness of LRG for evaluation of disease condition after adalimumab treatments - Investigation of the usefulness of LRG for evaluation of disease condition after adalimumab treatments |
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Date of first enrolment:
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2016/07/02 |
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Target sample size:
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100 |
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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=R000023044 |
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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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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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Yukimi
Kokubun |
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Address:
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5F Shinwa-building, 3-2-4, Nishi-shinjuku, Shinjuku-ku, Tokyo
160-0023
Japan |
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Telephone:
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03-5325-5821 |
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Email:
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adalrg-project@umin.ac.jp |
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Affiliation:
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RPM Co., Ltd. Clinical Development Div. |
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Name:
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Takayuki
Matsumoto |
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Address:
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19-1, Uchimaru, Morioka, Iwate/185-1 Kohasu,Oko-cho,Nankoku-shi,Kochi/35, Shinanomachi, Shinjuku-ku, Tokyo
Japan |
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Telephone:
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019-651-5111 |
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Email:
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adalrg-project@umin.ac.jp |
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Affiliation:
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Iwate Medical University Internal Medicine, The center for Immune Intractable Disease |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 1. Patients with history of following intestinal surgery. Patients who are scheduled for following surgery. CD : enterectomy within 12 weeks prior to enrollment pouch or stoma (except rectostomy) UC : subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch, Kock pouch and ileostomy 2. Patients with history of adalimumab treatment 3. Patients who had not showed initial response to infliximab before and patients with secondary failure to infliximab 10 mg/kg 4. Patients with serious infections 5. Patients with active tuberculosis 6. Patients with a history of hypersensitivity toadalimumab 7. Patients with demyelinating disease (Multiple sclerosis, etc) or with history of demyelinating disease 8. Patients with congestive heart failure 9. Patients who is determined inappropriate to participate to this study by the investigator.
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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Crohn's disease, ulcerative colitis
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Intervention(s)
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Patients with Crohn's disease or ulcerative colitis Adalimumab administration subcutaneously for 52 weeks using the recommended dosing regimens.
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Primary Outcome(s)
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-Correlation between biomarkers and disease activity/endoscopic findings
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Secondary Outcome(s)
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- Change of biomarkers (LRG, fCal, CRP) and disease activity - Correlations between several biomarkers. - Cutoff value, sensitivity and specificity of biomarkers in the stage of disease activity (remission)/endscopic findings(healing) - Usefulness of biomarkers for predicting prognosis of IBD - Effects on adalimumab concentration and anti-drug antibody titer for disease activity/endoscopic findings and biomarker.
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Source(s) of Monetary Support
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Eisai Co., Ltd.
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Ethics review
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Status: YES
Approval date: 27/01/2016
Contact:
kenkyu@j.iwate-med.ac.jp
Iwate Medical University School of Medicine Ethics Committee
019-651-5111
kenkyu@j.iwate-med.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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20/11/2018 |
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URL:
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