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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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ChiCTR |
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Last refreshed on:
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30 September 2019 |
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Main ID: |
ChiCTR1900026091 |
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Date of registration:
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2019-09-20 |
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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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Development of a predictive nomogram for primary non-response to infliximab in patients with Crhon's disease
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Scientific title:
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Development of a predictive nomogram for primary non-response to infliximab in patients with Crhon's disease: a multicenter study |
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Date of first enrolment:
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2019-09-19 |
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Target sample size:
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Case series:343; |
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Recruitment status: |
Pending |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=41815 |
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Study type:
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Observational study |
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Study design:
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Single arm
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Phase:
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Retrospective study
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Countries of recruitment
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China
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Contacts
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Name:
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Shenghong Zhang
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Address:
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58 Second Zhongshan Road, Yuexiu District, Guangzhou, Guangdong, China
510000
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Telephone:
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+86 13570527027 |
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Email:
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shenghongzhang@163.com |
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Affiliation:
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The First Affiliated Hospital of Sun Yat-sen University |
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Name:
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Xiaoqi Ye
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Address:
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58 Second Zhongshan Road, Yuexiu District, Guangzhou, Guangdong, China
510000
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Telephone:
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+86 13826479129 |
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Email:
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yexq3@mail2.sysu.edu.cn |
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Affiliation:
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The First Affiliated Hospital of Sun Yat-sen University |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. A diagnosis of Crohn's disease based on clinical, radiographic, endoscopic, and histological evidence in the center;
2. Endoscopic active with Crohns disease index of severity (CDEIS) more than 3 before treatment of infliximab;
3. Complement of induction of infliximab of 5mg/kg at week 0, 2, 6 in the medical center.
Exclusion criteria: 1. Previous ileac, colonic or ileocolonic resection;
2. Lack of ileocolonoscopy before induction of IFX or at week 14 since the first induction of IFX;
3. Incomplete data.
Age minimum:
9
Age maximum:
58
Gender:
Both
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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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Case series:infliximab;
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Primary Outcome(s)
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Primary non-response to infliximab;
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Source(s) of Monetary Support
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No funding
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Ethics review
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Status: Approved
Approval date: 12/09/2019
Contact:
Haifeng Lin
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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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