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. |
Register:
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ChiCTR |
Last refreshed on:
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22 May 2017 |
Main ID: |
ChiCTR-OPC-17011391 |
Date of registration:
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2017-05-12 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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The efficacy and safety of tocilizumab for refractory systemic juvenile idiopathic arthritis in China
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Scientific title:
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The efficacy and safety of tocilizumab for refractory systemic juvenile idiopathic arthritis in China |
Date of first enrolment:
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2016-09-01 |
Target sample size:
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tocilizumab group:36;glucocorticoid group:24; |
Recruitment status: |
Completed |
URL:
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http://www.chictr.org.cn/showproj.aspx?proj=18683 |
Study type:
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Observational study |
Study design:
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Cohort study
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Phase:
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Post-market
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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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Xuemei Tang
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Address:
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136 Second Zhongshan Road, Yuzhong District, Chongqing, China
400014
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Telephone:
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+86 13012352441 |
Email:
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tangxuemei2008@163.com |
Affiliation:
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Children's Hospital of Chongqing Medical University |
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Name:
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Li Xu
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Address:
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136 Second Zhongshan Road, Yuzhong District, Chongqing, China
400014
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Telephone:
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+86 18623694243 |
Email:
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lixu_1990@yeah.net |
Affiliation:
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Children's Hospital of Chongqing Medical University |
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Key inclusion & exclusion criteria
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Inclusion criteria: Eligible patients aged 2 to 16 years, with a diagnosis of sJIA according to the International League of Associations for Rheumatology criteria. Refractory sJIA is defined as who showed an inadequate response to NSAIDs (fever present after treatment with stable doses of NSAIDs for 2 weeks), were dependent on glucocorticoids (symptoms were aggravated or relapsed when the glucocorticoid dose was reduced), or showed no response to glucocorticoid therapy were included.
Exclusion criteria: Acute or chronic infection (including tuberculosis), tumors, cardiac insufficiency, and other chronic diseases were excluded prior to administration of tocilizumab.
Age minimum:
2
Age maximum:
16
Gender:
Both
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Health Condition(s) or Problem(s) studied
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systemic juvenile idiopathic arthritis
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Intervention(s)
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tocilizumab group:tocilizumab;glucocorticoid group:glucocorticoid;
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Primary Outcome(s)
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Juvenile Arthritis Disease Activity Score 27;inflammation index (ESR, CRP);
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Source(s) of Monetary Support
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Chongqing Science and Technology Commission
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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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