Arthritis, Juvenile Rheumatoid Clinical Trial
Official title:
Single Patient Use of Tocilizumab for Treatment of Steroid Dependent, Active Systemic Onset Juvenile Idiopathic Arthritis
The purpose of this study is to see if tocilizumab is safe and effective for treating systemic onset Juvenile Idiopathic Arthritis (soJIA). Another purpose is to see if tocilizumab helps reduce the amount of steroids (prednisone) needed to control symptoms of soJIA.
Systemic onset Juvenile Idiopathic Arthritis (soJIA) is a type of arthritis (inflammation of
the joints) that occurs with other symptoms including fever, swollen lymph nodes (glands),
rash, and body aches. Because soJIA can be difficult to treat, children with soJIA can have
severe problems from long-term use of steroids (prednisone). These problems include low bone
density (weak bones), fractures, failure to grow properly, and large weight gain. The
arthritis that occurs in soJIA often causes damage to many joints. This can make it hard to
move around or do basic tasks like dressing. Also, a life-threatening illness called
Macrophage Activation Syndrome (MAS) can occur when starting, stopping, or changing drugs
that are used to treat soJIA.
SoJIA can be hard to treat and many children with soJIA do not respond to drugs that work
for other kinds of arthritis. Research doctors have studied a chemical signal called IL-6
that the body uses to manage inflammation. This signal has been found to be very high in
patients with active soJIA. A drug called tocilizumab (TCZ) has been designed to block IL-6.
For about 6 years, TCZ has been tested in Japan for treating soJIA. It is now being tested
in studies in the United States. These studies can have very strict rules for enrolling
patients. This trial is a single-patient research study for a subject who otherwise does not
meet the rules for enrollment in ongoing trials.
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