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

Completed · Phase 3 · Has a placebo group

Conditions studied: Juvenile Idiopathic Arthritis

In brief

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.

Key facts

Study ID

NCT00642460

Run by

Hoffmann-La Roche

People needed

112

Starts

2008-05-01

Expected to finish

2014-08-01

Last updated by the study team

2016-07-25

Who can join

Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients aged 2-17 years of age
• Systemic juvenile idiopathic arthritis with >= 6 months persistent activity
• Presence of active disease (>=5 active joints, or >=2 active joints + fever + steroids)
• Inadequate clinical response to nonsteroidal anti-inflammatory drugs (NSAIDs) and corticosteroids due to toxicity or lack of efficacy

You may not qualify if…

• Wheelchair-bound or bed-ridden
• Any other autoimmune, rheumatic disease or overlap syndrome other than systemic juvenile idiopathic arthritis
• Intravenous long-acting corticosteroids or intra-articular corticosteroids within 4 weeks of baseline, or throughout study
• Disease-modifying antirheumatic drugs (DMARDs), other than methotrexate
• Previous treatment with tocilizumab

Where it is running

• Study site — Los Angeles, California, United States
• Study site — Hartford, Connecticut, United States
• Study site — Augusta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Louisville, Kentucky, United States
• Study site — Hackensack, New Jersey, United States
• Study site — Livingston, New Jersey, United States
• Study site — Durham, North Carolina, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Cleveland, Ohio, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Houston, Texas, United States
• Study site — Buenos Aires, Argentina
• Study site — Buenos Aires, Argentina
• Study site — La Plata, Argentina
• Study site — Parkville, Australia
• Study site — Subiaco, Australia
• Study site — Westmead, Australia
• Study site — Ghent, Belgium
• Study site — Leuven, Belgium
• Study site — Porto Alegre, Brazil
• Study site — Rio de Janeiro, Brazil
• Study site — São Paulo, Brazil
• Study site — Vancouver, British Columbia, Canada
• Study site — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.