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

Genentech

Status: Completed

Conditions: Granulomatosis With Polyangiitis; Microscopic Polyangiitis

Treatments: Drug: Rituximab

Study type: Observational

Funder types: Industry

Identifiers

NCT01613599

WA27893

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 1 patient group

Rituximab

Description:

Participants with granulomatosis with polyangiitis (GPA) (Wegener's granulomatosis) or microscopic polyangiitis (MPA) who received rituximab as per investigator's discretion were followed for a maximum of 4 years.

Treatment:

Drug: Rituximab