NCT00642460

A Study of RoActemra/Actemra (Tocilizumab) in Patients With Active Systemic Juvenile Idiopathic Arthritis (JIA)

A Randomized, Placebo-controlled Study to Evaluate the Effect of Tocilizumab on Disease Response in Patients With Active Systemic Juvenile Idiopathic Arthritis (JIA), With an Open-label Extension to Examine the Long Term Use of Tocilizumab

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in patients with active systemic juvenile idiopathic arthritis (sJIA) who have an inadequate clinical response to NSAIDs and corticosteroids. In Part I of the study patients will be randomized 2:1 to receive iv infusions of RoActemra/Actemra (8mg/kg iv for patients \>=30kg, or 12mg/kg for patients \<30kg) or placebo, every 2 weeks. Stable NSAIDs and methotrexate will be continued throughout. After 12 weeks of double-blind treatment, all patients will have the option to enter Part II of the study to receive open-label treatment with RoActemra/Actemra for a further 92 weeks, followed by a 3-year continuation of the study in Part III in which, for patients who meet specific criteria, an optional alternative dosing schedule decreasing the study drug administration frequency will be introduced. Anticipated time on study treatment is up to 5 years.

Conditions

• Juvenile Idiopathic Arthritis

Interventions

Type	Name	Description
DRUG	tocilizumab [RoActemra/Actemra]	8mg/kg (patients\>=30kg) or 12mg/kg (patients \<30kg) iv every 2 weeks. In Part III, administration frequency may be reduced to every 3 and every 4 weeks, respectively, according to an optional alternative dosing schedule.
DRUG	Placebo	iv every 2 weeks for 12 weeks
DRUG	Non-steroidal anti-inflammatory drugs (NSAIDs)	as prescribed
DRUG	methotrexate	as prescribed
DRUG	corticosteroids	orally, as prescribed

Timeline

• Start date: 2008-05-01
• Primary completion: 2009-09-01
• Completion: 2014-08-01
• First posted: 2008-03-25
• Last updated: 2016-07-25
• Results posted: 2011-10-26

Locations

54 sites across 19 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Czechia, Denmark, Germany, Greece, Italy, Mexico, Netherlands, Norway, Poland, Slovakia, Spain, Sweden, United Kingdom