MA22460 Long Term Extension Study

• Research type

  Research Study

• Full title

  Extension Phase of the Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy

• IRAS ID

  12710

• Contact name

  Andrew Ostor

• Sponsor organisation

  F. Hoffmann La Roche

• Eudract number

  2008-006924-68

• ISRCTN Number

  n/a

• Research summary

  Major advances have occurred in the treatment of Rheumatoid Arthritis (RA) over the last 10 years with new biologic agents being more effective in more patients than traditional disease modifying anti-rheumatic drugs (DMARDS). 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 class of agent which (in clinical trials) 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 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.Patients who completed the 24-week MA21573 core study and had at least a moderate response (pre-defined criteria) will be offered entry to this separate long-term extension study. Safety, tolerability and efficacy data will be collected during the extension phase. All suitable patients will receive TCZ by IV infusion and evaluated for Adverse Events every 4 weeks. All other study procedures and assessments will be reduced to every 12 weeks compared to 4 weeks in the MA21573 core study. The last visit at week 24 of the MA21573 core study is considered the day 1 visit of the extension study. TCZ will be available for up to 4 weeks after TCZ becomes commercially available in the respective country or for a maximum period of 104 weeks ( weeks follow-up) after an individual patient has entered the extension study, whichever occurs first.

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  09/H0605/10

• Date of REC Opinion

  6 Mar 2009

• REC opinion

  Further Information Favourable Opinion