Phase 3 Trial in patients with systemic juvenile idiopathic arthritis
A 12-Week randomized, double blind, placedo-controlled, parallel group, 2-arm study to evaluate the efficacy and safety of tocilizumab in patients with active systematic juvenile idiopathic arthritis (sJIA); with a 92-week single arm open-label extension to examine the long term use of tocilizumab followed by a 3 year open label continuation of the study to examine the long term use of tocilizumab.
F. Hoffman-La Roche
108 children aged 2 to 17 with systemic Jeuvenile Idiopathic [no known cause] Arthritis will be asked to volunteer to be treated with tocilizumab. It is hoped treatment with tocilizumab will reduce the pain and joint swelling related to arthritis. For the first twelve weeks of the study (Part 1) about 2 out of 3 of the children on this study will be given tocilizumab by chance. The selection is made by a computer and is called the double-blind period of the study. One out of 3 will receive something like tocilizumab but which has no tocilizumab in it, a placebo. This is to see how the child who is given tocilizumab feels, compared to those that don??t. No one will know who is getting tocilizumab for those first 12 weeks; not the doctor, the nurse, the child, or their family. All the children in the study are treated the same way whether they are given tocilizumab or not. The tocilizumab will be given as an infusion in the arm every 2 weeks of the study. If during the first twelve weeks a child??s arthritis causes trouble with their joints, or a fever develops, or irritation develops in the lining of the lungs or heart, the medication might change; if the child was receiving placebo, they might get tocilizumab. After the first twelve weeks of the study, in Part 2, all children who remain in the study will get tocilizumab. This is known as the open-label period because everyone knows each child is getting tocilizumab. If the child??s arthritis improves they can continue in the study and every 2 weeks they will be given tocilizumab until the study end (about 2 years). The study is sponsored by Roche Products Limited and will recruit children at Great Ormond Street Hospital, London.
London - Central Research Ethics Committee
Date of REC Opinion
3 Oct 2008
Further Information Favourable Opinion