Subcutaneous Tocilizumab in Rheumatoid Arthritis

• Research type

  Research Study

• Full title

  A randomized, double-blind, parallel group study of the safety and effect on clinical outcome of tocilizumab SC versus tocilizumab IV, in combination with traditional disease modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis.

• IRAS ID

  37788

• Contact name

  Alan Hakim

• Sponsor organisation

  Roche Products Limited

• Eudract number

  2010-018375-22

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This study has been designed to assess the safety and efficacy of subcutaneous (SC) tocilizumab in comparison to the current intravenous (IV) formulation that's licensed for use in the UK as RoActemra. The main objective is to demonstrate ‘equivalence’ in efficacy between the two formulations. If the SC formulation proves to be as efficacious as IV RoActemra, the potential benefit to patients is that they will be able to inject at home on a weekly basis instead of attending hospital monthly for an IV infusion. The design of the trial is such that patients will be randomly assigned to either the SC or IV formulation, but in order to maintain ‘blinding’ in the study all patients will receive both SC and IV agents for the first 24 weeks where one will be placebo and one active medication. After 24 weeks all patients will then enter the open label treatment phase. A total of 1200 patients will be recruited globally. Once a patient consents to participate, they will have screening assessments to ensure they are eligible. Once they commence treatment they will attend weekly assessments for the first month, then monthly for the remainder of the study over a total period of 2 years. Out of 600 patients initially receiving active SC and placebo IV for 24 weeks, 550 will then receive just active SC, whilst the remaining 50 patients will receive active IV treatment for the remaining period of the study. From 600 patients who initially had active IV and placebo SC, 400 will receive active IV and 200 active SC medication. The intent of this design is to ensure that both patients and carers are unable to ascertain what the patient received during the first 24 weeks of treatment. Roche Products Limited is the sponsor company performing and funding this trial.

• REC name

  London - South East Research Ethics Committee

• REC reference

  10/H1102/43

• Date of REC Opinion

  14 Sep 2010

• REC opinion

  Further Information Favourable Opinion