ML25243 - Neutrophil function with Tocilizumab in Rheumatoid Arthritis

• Research type

  Research Study

• Full title

  A 52 week, Single center, Open-label Study to Evaluate Neutrophil function and survival effects of Tocilizumab (TCZ) in Patients with Active Rheumatoid Arthritis (RA) on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy

• IRAS ID

  44222

• Contact name

  Robert Moots

• Sponsor organisation

  Roche Products Ltd.

• Eudract number

  2010-018331-18

• ISRCTN Number

  NA

• Research summary

  ML25243 Lay Summary for Ethics Submission Major advances have occurred in the treatment of Rheumatoid Arthritis (RA) over the last 10 years with new biologic agents (active substances produced from or extracted from a biological (living) system) being more effective in more patients than traditional treatments. However, around a third of patients fail to reach an adequate response to these agents so there is a need for new agents to developed. Tocilizumab (TCZ) is a new type of medicine which in clinical trials has been shown to be effective in RA and to be well tolerated. A product licence, which allowed tocilizumab to be marketed, had been applied for using the clinical trial data obtained to date and the purpose of this study is to obtain additional safety and efficacy data in a broader patient population. In contrast to the trials completed so far, this will attempt to study a patient population that is more representative of RA patients treated by rheumatologists in their daily clinical practice. Safety, tolerability and efficacy data (data that shows how safe and well accepted by the body tocilizumab is, as well as how well it works) will be collected during this study. The inflammation process of rheumatoid arthritis will also be studied and patients may also become involved in a separate additional research project which will study the genetic product RNA from their blood samples while receiving treatment with tocilizumab. All suitable patients will receive TCZ by IV infusion and evaluated for Adverse Events every 4 weeks. An adverse event is defined as any unfavourable and unintended sign, symptom or disease that occurs during the course of the study. IV Infusion is short for intravenous, which means putting a liquid, like the tocilizumab solution, into a vein in the body. All other study procedures and assessments will be every 4 weeks for a total of 1 year and patients will receive a total of 13 infusions every 4 weeks for 48 weeks, followed by a follow up visit, without an infusion, at week 52.

• REC name

  North East - Tyne & Wear South Research Ethics Committee

• REC reference

  10/H0904/14

• Date of REC Opinion

  12 May 2010

• REC opinion

  Further Information Favourable Opinion