Rituximab Surveillance Study in Vasculitis (RIVAS)
Research type
Research Study
Full title
Long-term surveillance study of rituximab (MabThera)-treated patients with Granulomatosis with Polyangiitis (GPA) or Microscopic Polyangiitis (MPA)
IRAS ID
186392
Contact name
David Jayne
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust
Duration of Study in the UK
5 years, 0 months, 0 days
Research summary
Granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA)are disorders caused as a result of inflammation of blood vessels, also called vasculitis. Rituximab (MabThera) is a licenced drug for use in GPA and MPA to induce remission (i.e. to control symptoms of the disease). However, there is little data available on the long-term safety profile of the use of rituximab in this setting.
The RIVAS study is a long-term surveillance study where patients with GPA or MPA who have been treated with rituximab, or have planned treatment with rituximab will be followed up for up to 5 years in this data-collection study. Data will be collected during routine clinic visits, every 6 months over the 5 year study period. Patients with GPA or MPA who are not treated with Rituximab, but receive another therapy will also be observed as comparators. The data collected will be added to the UKIVAS registry database, and extracted anonymously for periodic analysis of safety outcomes following rituximab use in GPA or MPA remission induction.
REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
16/EM/0355
Date of REC Opinion
9 Aug 2016
REC opinion
Favourable Opinion