LONG-TERM SURVEILLANCE STUDY OF RITUXIMAB (MABTHERA)-TREATED PATIENTS WITH GRANULOMATOSIS WITH POLYANGIITIS (GPA) OR MICROSCOPIC POLYANGIITIS (MPA) (RIVAS)

Study identification

• EU PAS number:
  EUPAS16359
• Study ID:
  50725
• Official title and acronym:
  LONG-TERM SURVEILLANCE STUDY OF RITUXIMAB (MABTHERA)-TREATED PATIENTS WITH GRANULOMATOSIS WITH POLYANGIITIS (GPA) OR MICROSCOPIC POLYANGIITIS (MPA) (RIVAS)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  This study is a non-interventional secondary data safety study in patients with GPA/MPA exposed to rituximab or other available treatments as part of their standard clinical care. Data will be extracted from the Cambridge site within UKIVAS database. Patients in each treatment cohort (rituximab or other available treatment regimens) will be followed from time of disease flare or disease diagnosis since 2003 (year of first use of rituximab) in Cambridge (total target study sample size approximately 400). Patients who switch treatment regimens during the course of their registry follow-up will continue to be followed with date of switching recorded. Data will be extracted to the end of study, loss to follow-up or to withdrawal of consent or death and will be evaluated and patients treated according to physician’s standard practice.
• Study status:
  Finalised

Research institutions and networks

Institutions

Addenbrooke's Hospital

Vasculitis Office

Study timelines

Date when funding contract was signed

Actual:15/12/2015

Study start date

Actual:07/10/2016

Data analysis start date

Actual:07/10/2016

Date of final study report

Planned:30/09/2023

Actual:20/06/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Roche

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)

Other study registration identification numbers and links

BE29950