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anaSTILLs Study for Still's Disease - Clinical Trial

What is the Purpose of this Study?

We are doing this study learn whether Anakinra is safe and will work to treat patients across all age groups with newly diagnosed Still's disease.

What is the Condition Being Studied?

Still's Disease

Who Can Participate in the Study?

To be in this study, your child must:
- Be diagnosed with Still's Disease within 6 months of study enrollment
- Weigh 10kg (about 22 pounds) or more.
- Have stable dose of glucocorticoid for at least 1 week prior to being randomly assigned.
- Have stable dose of methrotrexate for at least 8 weeks prior to being randomly assigned.

Age Group
Adults, Children

What is Involved?

If you decide that you would like for your child to be part of this study, your child will:
- Be randomly given (like the flip of a coin) the study medicine, Anakinra, or a placebo (like sugar or salt-water) .
-- Or you (the parent) will be trained to give the study medicine or placebo.  
- Be involved in 6 study visits and 2 telephone visits over 16 weeks.
- Get vitals, questionnaires, physical exam, and blood tests.

Study Details

Full Title
A randomized, double-blind, placebo-controlled, multicenter, phase 3 efficacy and safety study of 2 dose levels of subcutaneous anakinra (Kineret) in patients with Still's disease (SJIA and AOSD)
Principal Investigator
Pediatric Rheumatologist
Protocol Number
IRB:PRO00085356
NCT:NCT03265132
Phase
Phase III
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698