A study to evaluate GP2013 and rituximab in RA

• Research type

  Research Study

• Full title

  A randomized, double-blind, controlled study to evaluate pharmacokinetics, pharmacodynamics, safety and efficacy of GP2013 and rituximab in patients with rheumatoid arthritis refractory or intolerant to standard DMARDs and one or up to three anti-TNF therapies

• IRAS ID

  166730

• Contact name

  Tamas Shisha

• Contact email

  tamas.shisha@sandoz.com

• Sponsor organisation

  Hexal AG

• Eudract number

  2010-021184-32

• Clinicaltrials.gov Identifier

  NCT01274182

• Duration of Study in the UK

  1 years, 9 months, 24 days

• Research summary

  The purpose of this study is to assess the similarities between GP2013 (study drug) and already approved drugs MabThera/Rituxan. In the treatment of patient with Rheumatoid Arthritis, who did not respond well to, or were intolerant to, other standard of care treatment like disease modifying anti-rheumatoid drugs (DMARDS) and anti-tumor necrosis factor therapies.

• REC name

  Yorkshire & The Humber - Leeds West Research Ethics Committee

• REC reference

  15/YH/0011

• Date of REC Opinion

  25 Mar 2015

• REC opinion

  Further Information Favourable Opinion