MabThera DUS V3.0

• Research type

  Research Study

• Full title

  MabThera drug utilisation study and patient alert card evaluation in non- oncology patients in Europe: An infusion centre-based approach.

• IRAS ID

  188959

• Contact name

  Jon King

• Contact email

  jonking@nhs.net

• Sponsor organisation

  Roche ltd

• Research summary

  Rituximab (MabThera) received European Medicines Agency (EMA) approval in June 2006 for the treatment in combination with methotrexate of adult patients with severe, active Reumathoid Arthiritis who have had an inadequate response or intolerance to other diseasemodifying antirheumatic drugs including one or more tumour necrosis factor (TNF) inhibitor therapies. In March 2013, the EMA approved a new non–
  oncologyrelated indication, allowing the use of MabThera in combination with glucocorticoids for the induction of remission in adult patients with severe, active granulomatosis with polyangiitis (GPA) (Wegener’s) and microscopic polyangiitis (MPA). This protocol addresses the 2 European Union (EU) followup measures (FUMs) associated with the marketing of Mabthera for non- oncology indications.
  Assessment off label use and evaluation of patient alert card.

  This study is not linked to any previous studies using Mabthera.

• REC name

  West of Scotland REC 4

• REC reference

  15/WS/0268

• Date of REC Opinion

  18 Nov 2015

• REC opinion

  Further Information Favourable Opinion