RA-EXTEND

• Research type

  Research Study

• Full title

  A multi-center, uncontrolled extension study evaluating safety and efficacy of SAR153191 on top of DMARDs in patients with active Rheumatoid Arthritis (RA)

• IRAS ID

  141871

• Contact name

  Paul Emery

• Contact email

  P.Emery@leeds.ac.uk

• Sponsor organisation

  sanofi-aventis Recherche & Développement

• Eudract number

  2010-019262-86

• Research summary

  The purpose of this study is to determine if sarilumab (200 mg or if needed 150 mg) given by subcutaneous injection every other week is safe and effective in reducing the recurrence and symptoms of rheumatoid arthritis over a long period of time (for up to 220 weeks). This is an extension study to the Ascertain study (Ref ref: 13/LO/0449).
  Sarilumab belongs to a class of drugs called anti-Interleukin 6 Receptor monoclonal antibody (a type of protein) that blocks the activity of interleukin 6 in the body. Sarilumab is an investigational drug.
  The study will include approximately 2100 men and women at least 18 years of age and will be conducted worldwide.
  The study will comprise of a treatment period of up to 220 weeks to assess the effect of treatment with the study drug will take place. Finally, a post-treatment follow-up approximately 6 weeks from last drug administration will take place.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  13/LO/1906

• Date of REC Opinion

  13 Jan 2014

• REC opinion

  Further Information Favourable Opinion