Status: Recruiting

Official Title: 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.

Brief Summary: 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.

Study Phase: 3

Study Type: Interventional; Prevention; Non-Randomized; Open Label; Uncontrolled; Parallel; Safety/Efficacy study

Condition: Juvenile Idiopathic Arthritis

Intervention Type: Drug

Intervention Name: tocilizumab [RoActemra]

• children/juveniles, 2-17 years of age
• polyarticular-course juvenile idiopathic arthritis (pcJIA) >/=6 months duration
• active disease (>/=5 active joints, >/=3 with limitation of motion)
• inadequate response to or inability to tolerate methotrexate
• methotrexate, oral corticosteroids and NSAIDs at stable dose(at least 8,4 and 2 weeks,respectively) prior to baseline
• biologics discontinued, between at least 1 and 20 weeks prior to baseline, depending on biologic

• auto-immune, rheumatic disease or overlap syndrome other than polyarticular-course JIA
• wheelchair bound or bedridden
• intraarticular, intramuscular, intravenous or long-acting corticosteroids within 4 weeks prior to baseline
• DMARDs (other than methotrexate) within 4 weeks prior to baseline
• previous treatment with tocilizumab

This trial will be conducted at the following locations:

• HACKENSACK 07601
• HARTFORD
• CHICAGO
• TULSA
• CINCINNATI
• DELRAY BEACH
• NEW ORLEANS
• MIAMI
• LOUISVILLE
• LOS ANGELES
• WASHINGTON

• SANKT AUGUSTIN 53757
• BREMEN
• BERLIN
• FRANKFURT/MAIN

• UTRECHT 3584 AE
• ROTTERDAM

• PARIS 75743
• LE KREMLIN BICÊTRE
• BORDEAUX
• VANDOEUVRE-LES-NANCY
• PARIS
• MONTPELLIER

• GENOVA 16147
• ROMA
• PADOVA
• MILANO
• FIRENZE

• RIO DE JANEIRO 21941-912
• SAO PAULO
• PORTO ALEGRE
• RIO DE JANEIRO

• MELBOURNE 3052
• SUBIACO
• WESTMEAD

• MOSCOW 119991
• SAMARA
• MOSCOW
• MOSCOW
• SAINT-PETERSBURG
• ROSTOV-NA-DONU

• BRISTOL BS2 8BJ
• LONDON
• LIVERPOOL

• TORONTO M5G 1X8
• OTTAWA
• VANCOUVER
• CALGARY

• LIMA 11
• LIMA
• LIMA

• GENT 9000
• LEUVEN

• MIEXICO CITY 06700
• MONTERREY
• MEXICO CITY
• MEXICO CITY

• BUENOS AIRES 1270
• TUCUMAN
• ROSARIO
• LA PLATA

• VALENCIA 46009
• MADRID
• CÓRDOBA
• SEVILLA
• MADRID

• LUBLIN 20-093
• KRAKÓW
• WARSZAWA
• BYDGOSZCZ
• LODZ