Brief Title
An Observational Study of The Safety of MabThera/Rituxan (Rituximab) in Participants With Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis
Official Title
Prospective, Observational Safety Study of Patients With Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis Treated With Rituximab
Brief 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.
Study Type
Observational
Primary Outcome
Incidence Rate of Serious Infections
Secondary Outcome
Percentage of Participants With a Serious Infusion-related Reaction
Condition
Granulomatosis With Polyangiitis
Intervention
Rituximab
Study Arms / Comparison Groups
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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
100
Start Date
June 20, 2012
Completion Date
April 28, 2017
Primary Completion Date
July 13, 2015
Eligibility 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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Clinical Trials, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01613599
Organization ID
WA27893
Responsible Party
Sponsor
Study Sponsor
Genentech, Inc.
Study Sponsor
Clinical Trials, Study Director, Genentech, Inc.
Verification Date
July 2018