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

Completed

Conditions studied: Granulomatosis With Polyangiitis, Microscopic Polyangiitis

In brief

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.

Key facts

Study ID

NCT01613599

Run by

Genentech, Inc.

People needed

100

Starts

2012-06-20

Expected to finish

2017-04-28

Last updated by the study team

2018-07-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Mayo Clinic Arizona — Scottsdale, Arizona, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Mayo Clinic — Jacksonville, Florida, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Johns Hopkins Asthma&Allergy — Baltimore, Maryland, United States
• Mass. General Hospital — Boston, Massachusetts, United States
• Boston Medical Center — Boston, Massachusetts, United States
• Mayo Clinic Rochester; Int.Med - Div. of Pul — Rochester, Minnesota, United States
• Weill Medical College of Cornell University; Hospital for Special Surgery — New York, New York, United States
• UNC- Chapel Hill — Chapel Hill, North Carolina, United States
• Duke Univ Medical Center — Durham, North Carolina, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• University of Utah; Division of Rheumatology — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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