Anakinra to Treat Patients With Neonatal Onset Multisystem Inflammatory Disease

Inclusion criteria

• ✓. There is no age limitation.
• ✓. Patients fulfill at least 2 of the following 3 clinical manifestations:
• ✓. Onset of manifestations of NOMID/CINCA at less than or equal to 6 months of age.
• ✓. Stable dose of steroids, NSAIDs, DMARDs for 4 weeks prior to enrollment visit.
• ✓. Washout period for biologics: 6 half-lives before anakinra administration for all drugs with anti TNF properties. For etanercept (6 half-lives=24 days) this calculates to drug discontinuation 3 days before enrollment into the observation period, for infliximab and adalimumab (6 half-lives=48 days) drug will be discontinued 27 before the observation period, and for thalidomide (6 half-lives=3 days) drug will be discontinued for 3 days prior to anakinra administration.
• ✓. Patient's or legal guardian's ability and willingness to give informed consent.
• ✓. Females of childbearing potential (young women who have had at least one menstrual period regardless of age) must have a negative urine pregnancy test at baseline prior to performance of any radiologic procedure or administration of study medication. Women of childbearing age and men able to father a child, who are sexually active, will be asked to use a form of effective birth control, including abstinence.
• ✓. Negative PPD test using 5 T.U. intradermal testing per CDC guidelines with exception of inclusion criteria #9 below.

Exclusion criteria