Tocilizumab versus Adalimumab in Rheumatoid Arthritis

• Research type

  Research Study

• Full title

  A multi-centre, randomised, blinded, parallel-group study of the reduction of signs and symptoms during monotherapy treatment with tocilizumab 8 mg/kg intravenously versus adalimumab 40 mg subcutaneously in patients with rheumatoid arthritis.

• IRAS ID

  41676

• Contact name

  Thomas Sheeran

• Sponsor organisation

  Roche Products Ltd.

• Eudract number

  2009-015845-21

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This is a study of medications to treat people with rheumatoid arthritis (RA). All participants on the study will have RA. They must also have previously tried a common treatment for RA called methotrexate and either: a) this will not have worked sufficiently to relieve their symptoms b) they will have been unable to tolerate this drug meaning that it is not appropriate for the patient to continue taking methotrexate. The aim of the study is to gather information on the use of a drug named tocilizumab in patients with RA for whom methotrexate is not an appropriate treatment. Tocilizumab has been shown to be effective in treating the symptoms of RA but is usually given in combination with methotrexate. To assess the effectiveness of giving this drug on its own, it will be compared to another drug which is known to be effective in the treatment of rheumatoid arthritis - adalimumab. In this study there will be two groups of participants - one group will be given a course of tocilizumab lasting 20 weeks, the other group will be given a course of adalimumab lasting 22 weeks. Neither the participant or their study doctor will know which treatment they are receiving as matching Ó?dummy? drugs (placebos) will be used. For example, patients being treated with tocilizumab will also be administered a dummy (inactive) drug which looks identical to adalimumab, and vice versa. After they complete their course of treatment, Participants will be followed up for around 12 weeks to check the status of their health.

• REC name

  East Midlands - Derby Research Ethics Committee

• REC reference

  10/H0405/22

• Date of REC Opinion

  24 Mar 2010

• REC opinion

  Further Information Favourable Opinion