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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: 3 July 2017
Main ID:  ChiCTR-INR-17011829
Date of registration: 2017-07-02
Prospective Registration: Yes
Primary sponsor: Shenzhen Children's Hospital
Public title: Multiple center's clinical treatment of systemic onset juvenile idiopathic arthritis with tocilizumab
Scientific title: Multiple center's clinical treatment of systemic onset juvenile idiopathic arthritis with tocilizumab
Date of first enrolment: 2017-08-01
Target sample size: Case:75;Control:75;
Recruitment status: Pending
URL:  http://www.chictr.org.cn/showproj.aspx?proj=20208
Study type:  Interventional study
Study design:  Randomized parallel controlled trial  
Phase:  New Treatment Measure Clinical Study
Countries of recruitment
China
Contacts
Name: Yang Jun   
Address:  Shenzhen Children’s Hospital, 7019 Yitian Road, Shenzhen, China 518026
Telephone: +86 18938690366
Email: rogasansz@163.com
Affiliation:  Shenzhen Children's Hospital
Name: Liang Fangfang   
Address:  Shenzhen Children’s Hospital, 7019 Yitian Road, Shenzhen, China 518026
Telephone: +86 18938690368
Email: liangfangfang2008@163.com
Affiliation:  Shenzhen Children's Hospital
Key inclusion & exclusion criteria
Inclusion criteria: 1. Pass the diagnosis standard of JIA from ILAR;
2. diagnosed as severe active period;
3. To be able to treated with appropriate glucocorticoid, MTX and/or NSAIDs, no other DMARDs allowed.

Exclusion criteria: 1) no latent diseases such as TB, HBV oe EBV;
2) no hypersensitivity to Tocilizumab or other accessories;
3) no macrophage activiation syndrome;
4) reject to sign the infromed consent;
5) participate in other clinical experiments simultaneously.


Age minimum:
Age maximum:
Gender: Both
Health Condition(s) or Problem(s) studied
Systemic onset juvenile idiopathic arthritis
Intervention(s)
Case:Tocilizumab;Control:Conventional Treatment;
Primary Outcome(s)
IL-1;IL-6;IL-18;TNF-a;S100A8;S100A9;Index of joint pain;Index of joints swelling;Reheating time;ESR;CRP;SF;
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
Health and Family Planning Commission of Shenzhen Municipality
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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