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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: ChiCTR
Last refreshed on: 22 May 2017
Main ID:  ChiCTR-OPC-17011391
Date of registration: 2017-05-12
Prospective Registration: No
Primary sponsor: Children's Hospital of Chongqing Medical University
Public title: The efficacy and safety of tocilizumab for refractory systemic juvenile idiopathic arthritis in China
Scientific title: The efficacy and safety of tocilizumab for refractory systemic juvenile idiopathic arthritis in China
Date of first enrolment: 2016-09-01
Target sample size: tocilizumab group:36;glucocorticoid group:24;
Recruitment status: Completed
URL:  http://www.chictr.org.cn/showproj.aspx?proj=18683
Study type:  Observational study
Study design:  Cohort study  
Phase:  Post-market
Countries of recruitment
China
Contacts
Name: Xuemei Tang   
Address:  136 Second Zhongshan Road, Yuzhong District, Chongqing, China 400014
Telephone: +86 13012352441
Email: tangxuemei2008@163.com
Affiliation:  Children's Hospital of Chongqing Medical University
Name: Li Xu   
Address:  136 Second Zhongshan Road, Yuzhong District, Chongqing, China 400014
Telephone: +86 18623694243
Email: lixu_1990@yeah.net
Affiliation:  Children's Hospital of Chongqing Medical University
Key inclusion & exclusion criteria
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
Health Condition(s) or Problem(s) studied
systemic juvenile idiopathic arthritis
Intervention(s)
tocilizumab group:tocilizumab;glucocorticoid group:glucocorticoid;
Primary Outcome(s)
Juvenile Arthritis Disease Activity Score 27;inflammation index (ESR, CRP);
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
Chongqing Science and Technology Commission
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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