MA21488 Tocilizumab with/without Methotrexate in Rheumatoid Arthritis

• Research type

  Research Study

• Full title

  Randomized placebo-controlled study to evaluate the safety and efficacy of adding tocilizumab (TCZ) to methotrexate (MTX) versus switching to TCZ (placebo-controlled), with possible addition of other disease-modifying anti-rheumatic drugs (DMARDs), in patients with active rheumatoid arthritis who have inadequately responded to prior MTX treatment.

• IRAS ID

  2897

• Sponsor organisation

  F. Hoffmann La−Roche

• Eudract number

  2008-001847-20

• ISRCTN Number

  N/A

• Research summary

  There have been some major advances in the treatment of RA during the past 10 years with new biologic agents being more effective in more patients than traditional treatments. However, around a third of patients fail to reach a good enough response to these agents so there is a need for new agents to be developed.Tocilizumab (TCZ) is a new class of agent which in clinical trials to date has been shown to be effective in RA and to be well tolerated. A product licence has been applied for using the clinical trial data obtained to date.This study is a Phase IIIb, randomised placebo-controlled study of tocilizumab with or without methotrexate to assess clinical response as measured by DAS28 remission in patients with an inadequate response to methotrexate and/or anti-TNF medication with active moderate to severe rheumatoid arthritis.All suitable patients will receive TCZ infusions every 4 weeks for 100 weeks and continue their pre-study MTX dose or matching placebo.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  08/H0604/167

• Date of REC Opinion

  19 Dec 2008

• REC opinion

  Further Information Favourable Opinion