CompletedNot Applicable

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

United States100 participantsStarted 2012-06-20

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Incidence Rate of Serious Infections

Timeframe: From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years)

Trial details

NCT IDNCT01613599

SponsorGenentech, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2015-07-13

Results submitted2016-07-06

View on ClinicalTrials.gov More Granulomatosis With Polyangiitis trials