WA28029 - Decreasing TCZ dosing frequency in patients with sJIA

• Research type

  Research Study

• Full title

  A PHASE IV STUDY TO EVALUATE DECREASED DOSE FREQUENCY IN PATIENTS WITH SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (SJIA) WHO EXPERIENCE LABORATORY ABNORMALITIES DURING TREATMENT WITH TOCILIZUMAB

• IRAS ID

  110701

• Contact name

  Eileen Baildam

• Sponsor organisation

  F Hoffmann-La Roche Ltd

• Eudract number

  2012-000444-10

• ISRCTN Number

  N/A

• Research summary

  Tocilizumab (8mg/kg for patients =30kg and 12mg/kg for patients <30kg) has been approved by health authorities to be taken every two weeks for the treatment of systemic juvenile arthritis (sJIA). We do not know if the effects are, good or bad, on childrens arthritis when they take the study drug (tocilizumab) every 3 weeks or every 4 weeks. The purpose of this study is to find out the effects of taking tocilizumab less often. Children will be invited to participant in this study when their sJIA is well controlled, and they have had an abnormal blood test result (low white cells, low platelet count, or abnormal liver test whilst on 2 weekly tocilizumab. We wish to see if these children will benefit from receiving tocilizumab less often (every 3 or 4 weeks).

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  12/EM/0393

• Date of REC Opinion

  9 Nov 2012

• REC opinion

  Further Information Favourable Opinion