A Study of Tocilizumab in Patients With Active Polyarticular-Course Juvenile Idiopathic Arthritis



Status:Archived
Conditions:Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:November 2009
End Date:October 2013

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A 24 Week Randomized, Double-blind, Placebo-controlled Withdrawal Trial With a 16 Week Open-label lead-in Phase, and 64 Week Open-label Follow-up, to Evaluate the Effect on Clinical Response and the Safety of Tocilizumab in Patients With Active Polyarticular-course Juvenile Idiopathic Arthritis.


This 3-part study will evaluate the efficacy and safety of tocilizumab in patients with
active polyarticular-course juvenile idiopathic arthritis who have an inadequate response
to, or were intolerant of methotrexate. In Part I of the study all patients will receive iv
infusions of tocilizumab (8mg/kg for patients >/=30kg, 8mg/kg or 10mg/kg for patients <30kg)
every 4 weeks for 16 weeks. For Part II, patients with an adequate response in Part I will
be randomized to receive either tocilizumab at the same dose as in Part I or placebo, every
4 weeks for up to 24 weeks. In Part III of the study patients will receive tocilizumab at
the same dose as in Part I every 4 weeks for up to another 64 weeks. Standard of care
therapy with or without NSAIDs, corticosteroids or methotrexate will continue throughout the
study. Anticipated time on study treatment is 2 years, and target sample size is 150-200
individuals.



We found this trial at
9
sites
Celebration, Florida
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Centralia, Illinois
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Centralia, IL
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Lima, OH
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Louisville, Kentucky
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Louisville, KY
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Metairie, Louisiana
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Metairie, LA
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Newington, Connecticut
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Newington, CT
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Ponca City, Oklahoma
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Ponca City, OK
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Washington, District of Columbia
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Washington,
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West Orange, New Jersey
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West Orange, NJ
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