Duke logo

DRI13925: Children and Adolescents with pcJIA - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find a safe dose of sarilumab in children of different age-groups and to understand whether sarilumab has any beneficial effects on polyarticular-course juvenile idiopathic arthritis (pcJIA) in children.

What is the Condition Being Studied?

Rheumatoid Factor-Negative or Rheumatoid Factor-Positive Polyarticular-Course Juvenile Idiopathic Arthritis subtype (pcJIA) or Oligoarticular-Extended Juvenile Idiopathic Arthritis subtype

Who Can Participate in the Study?

Children who:
- Are ages 2 to 17 years old.
- Have Rheumatoid Factor-Negative or Rheumatoid Factor-Positive Polyarticular-Course Juvenile Idiopathic Arthritis subtype (pcJIA) or Oligoarticular-Extended Juvenile Idiopathic Arthritis subtype
- 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 2 to 17 Years, with Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA) Followed by an Extension Phase
Principal Investigator
Pediatric Rheumatologist
Protocol Number
IRB:PRO00081529
NCT:NCT02776735
Phase
Phase II
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698