Mabthera Drug Utilisation Study and Patient Alert Card Evaluation in Non-Oncology Patients in Europe: An infusion Centre Based Approach (Mabthera DUS)

Study identification

• EU PAS number:
  EUPAS11957
• Study ID:
  24913
• Official title and acronym:
  Mabthera Drug Utilisation Study and Patient Alert Card Evaluation in Non-Oncology Patients in Europe: An infusion Centre Based Approach (Mabthera DUS)
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  Italy

  Spain

  United Kingdom
• Study description:
  follow-up measures (FUMs) following approval of Variation EMEA/H/C/165/II/65 forMabThera use in RA (1) FUM no. 68 (Clinical): Drug Utilisation Study (DUS) to AssessOff-Label Use and (2) FUM No, 71.1 (Pharmacovigilance): Evaluation of Receipt, Use, and Impact of the Patient Alert Card (PAC) on Infections, Including Progressive Multi-focal Leukoencephalopathy (PML).
• Study status:
  Finalised

Research institutions and networks

Institutions

Real World & Late Phase Research (RWLPR), Quintiles

France

Study timelines

Date when funding contract was signed

Planned: 15/08/2015

Actual: 15/12/2015

Study start date

Planned: 20/12/2015

Actual: 18/12/2015

Data analysis start date

Planned: 31/08/2017

Actual: 29/09/2017

Date of final study report

Planned: 01/02/2018

Actual: 13/04/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Roche Registration Ltd

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)

Other study registration identification numbers and links

BA28478