An Observational Study of The Safety of MabThera/Rituxan (Rituximab) in Participants With Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis

• Status: Completed
• Trial end date: 2017-04-28
• Target enrollment: 0
• Participant gender: All

Summary

This prospective observational study will evaluate the long-term safety of MabThera/Rituxan (rituximab) in participants with granulomatosis with polyangiitis (Wegener's) or microscopic polyangiitis. Data will be collected for a maximum of 4 years from participants initiated on MabThera/Rituxan therapy by their physician according to prescribing information.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genentech, Inc.
• Treatments: Rituximab

Criteria

Inclusion Criteria:

• Adult participants, >/= 18 years of age

• Granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA), according to Chapel Hill Consensus Conference Definitions for MPA and American College of Rheumatology (ACR) Criteria for the Classification of GPA

• Disease severity requiring rituximab treatment per the investigator's assessment

Exclusion Criteria:

• Prior use of rituximab (except if received within 4 weeks of screening)

• Known hypersensitivity to rituximab, to any component of the product, or to murine proteins

• Pregnant or breastfeeding women

• Diagnosis of Churg-Strauss syndrome