Tocilizumab in patients with early Rheumatoid Arthritis

• Research type

  Research Study

• Full title

  A multi-center, randomized, double-blind, parallel group study of the safety, disease remission and prevention of structural joint damage during treatment with tocilizumab (TCZ), as a monotherapy and in combination with methotrexate (MTX), versus methotrexate in patients with early, moderate to severe rheumatoid arthritis.

• IRAS ID

  26028

• Sponsor organisation

  Roche Products Ltd

• Eudract number

  2009-012759-12

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Rheumatoid arthritis (RA) is a progressive disease characterized by inflammation which leads to irreversible destruction and disability of the joints. Disease-modifying antirheumatic drugs (DMARDs), for example Methotrexate, are the cornerstone of RA treatment throughout all stages of the disease, and they maintain or improve physical function and halt joint damage. More recently, biological compounds that target cells involved in inflammation have been used successfully to treat RA, but some patients fail to respond to these therapies. There is a medical need for more effective treatments for RA. This study is looking at a biologic compound called Tocilizumab with Methotrexate, and will compare the effectiveness of four different medication combinations. This is a blinded study where patients and their study doctors will not know which combination they are receiving. In order for this to occur, some patients will receive something like the active drug, but which has no active drug in it ǽ?ª?? a placebo. The four combinations are: A. Tocilizumab alone with placebo Methotrexate B. Tocilizumab with Methotrexate C. A lower dose of Tocilizumab with MethotrexateD. Methotrexate alone with placebo Tocilizumab. Patients will receive the Tocilizumab once a month and Methotrexate once a week for two years. If patients in group C do not have an improvement in their RA, then the dose of Tocilizumab will be increased. If patients in group D do not have an improvement in their RA, then Tocilizumab will be added. The study population will consist of adult patients with early, moderate to severe rheumatoid arthritis that have not been treated with Methotrexate or a biologic agent previously. 1182 patients will be recruited worldwide. In the UK, this study will take place in rheumatology clinics within hospitals and is sponsored by Roche Products Ltd.

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  09/H1010/61

• Date of REC Opinion

  14 Oct 2009

• REC opinion

  Further Information Favourable Opinion