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DRI13926 Study of Sarilumab for Systemic Juvenille Idiopathic Arthritis (sJIA) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find the safest dose of sarilumab in children of different age groups and to learn whether sarilumab has any beneficial effects on systemic juvenile idiopathic arthritis (sJIA) in children.

What is the Condition Being Studied?

Systemic Juvenile Idiopathic Arthritis (sJIA)

Who Can Participate in the Study?

Children who: 
- Are ages 1 to 17 years old.  
- Have Systemic Juvenile Idiopathic Arthritis.
- Weigh between 10kg - 60kg (22-132 pounds)

Age Group
Children

What is Involved?

If you decide that your child will be part of this study, your child will:
- Receive the study medicine, Sarilumab, as an injection.
- Come to 10 scheduled visits during the first 12 weeks.
- Asked to continue in the 144-week extension phase (35 visits).
- Give blood samples.
- Be expected to be in this study for about 3 years.

Study Details

Full Title
An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 1 to 17 Years, with Systemic Juvenile Idiopathic Arthritis (sJIA), Followed by an Extension Pha
Principal Investigator
Pediatric Rheumatologist
Protocol Number
IRB:PRO00081530
NCT:NCT02991469
Phase
Phase II
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
studyrecruitment@duke.edu
or
919-681-5698