Anakinra to Treat Patients With Neonatal Onset Multisystem Inflammatory Disease

Stopped early · Phase 1/Phase 2

Conditions studied: Nervous System Malformations, Arthropathy, Neurogenic, Urticaria, Papilledema

In brief

This study will evaluate the safety and effectiveness of anakinra (Kineret) for treating patients with neonatal-onset multisystem inflammatory disease (NOMID), also known as chronic infantile neurological, cutaneous and arthropathy (CINCA) syndrome. This disease can cause rash, joint deformities, brain inflammation, eye problems, and learning difficulties. Immune suppressing medicines commonly used to treat other pediatric rheumatologic diseases do not suppress NOMID symptoms and, if used long-term and in high doses, can cause harmful side effects. Anakinra, approved by The Food and Drug Administration for treating rheumatoid arthritis in adults, blocks a substance called IL-1 that may be an important factor in causing the inflammation in NOMID.

Key facts

Study ID

NCT00069329

Run by

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

People needed

43

Starts

2003-09-01

Expected to finish

2010-04-01

Last updated by the study team

2016-12-01

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Having received live virus vaccine during 3 months prior to baseline visit (1st visit to NIH).
• Patients with active infections or a history of pulmonary TB infection with or without documented adequate therapy, Patients with current active TB, or recent close exposure to an individual with active TB are excluded from the study.
• Positive testing for HIV, Hepatitis B or C known or documented at screening, enrollment or baseline visit.
• Have a history of or concomitant diagnosis of congestive heart failure.
• History of malignancy.
• Recent use of IL-1 antagonist within the last three months or prior use of anti CD4 antibody.
• Known hypersensitivity to E. coli derived products or any components of anakinra.
• Presence of any other rheumatic disease or major chronic infectious/inflammatory/immunologic disease (e.g. inflammatory bowel disease, psoriatic arthritis, spondyloarthropathy, SLE in addition to NOMID/CINCA).
• Presence of the following at enrollment visit: ALT or AST greater than 2.0 x upper limit of normal (ULN) of the local laboratories values, creatinine greater than 1.5 xULN, WBC less than 3.6x10(9)/l; platelet count less than 150,000 mm(3).
• Enrollment in any other investigational clinical study or receiving an investigational agent, or has not yet completed at least 4 weeks since ending another investigational device or drug trial.
• Subjects for whom there is concern about compliance with the protocol procedures by subject and/or parent/s and legally acceptable representative/s.
• Lactating females or pregnant females.
• Patients with asthma will only be included after evaluation by a pulmonary and infectious disease consultation.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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