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

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  RITUXIMAB
• Medical condition to be studied:
  Granulomatosis with polyangiitis

  Microscopic polyangiitis

Population studied

• Short description of the study population:
  Patients aged 18 years or older diagnosed with granulomatosis with polyangitis (GPA) and microscopic polyangitis (MPA) exposed to the rituximab treatment identified through UKIVAS registry.; Inclusion criteria:; 1. Clinical diagnosis of GPA/MPA through use of the consensus algorithm for the classification of ANCA vasculitis and polyarteritis nodosa ; 2. Age ≥ 18 years; 3. Have given informed consent to participate in the UKIVAS registry; 4. Have given informed consent to participate in the RIVAS registry; 5. Any patients with GPA/MPA who has received rituximab (MabThera) for vasculitis since 2003; 6. Any GPA/MPA patient with disease flare since 2003 who has not received rituximab; ; Exclusion criteria:; 1. Patients with eosinophilic GPA; 2. Unwilling or unable to provide written informed consent for UKIVAS registry; 3. Unwilling or unable to provide written informed consent for RIVAS registry
• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with granulomatosis with polyangitis and microscopic polyangitis
• Estimated number of subjects:
  400

Study design details

• Main study objective:
  RIVAS is a secondary use of data study aimed to provide long-term safety data from the use of rituximab and other available therapies for patients with GPA or MPA.
• Outcomes:
  To provide long-term safety data on rituximab-treated patients with GPA/MPA. - To estimate the incidence of serious adverse events (SAEs), including infections, cardiovascular events and malignancies, following rituximab or other available treatments in patients with GPA/MPA. - To compare the incidence of each safety event over time between the rituximab-treated cohort and the cohort treated with other available therapies.
• Data analysis plan:
  The Principal Investigator will retrospectively analyse a pre-specified data-cut within the Cambridge center every 12 months for the cumulative study report. For each patient cohort, variables will be summarized using mean, median, standard deviation and range for continuous data, and counts and percentages for categorical data. Following the methodology used in rheumatoid arthritis, two main analytical approaches will be used depending on the outcome of interest. For analyses of risk of malignancy, the primary analysis will use an ever-exposed model that includes all person-time since the first drug dose in the study. For all SAEs except malignancy, the primary analysis will be based on a time-on-drug approach that uses a pre-defined risk window after the last administration of rituximab or other available therapies. An outcome of interest occurring during the defined risk window period will be allocated to the preceding treatment identically for both drug regimens.