An Observational Study of The Safety of MabThera/Rituxan (Rituximab) in Participants With Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis
NCT ID: NCT01613599
Last Updated: 2018-07-26
Study Results
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View full resultsBasic Information
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COMPLETED
100 participants
OBSERVATIONAL
2012-06-20
2017-04-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Rituximab
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.
Rituximab
Participants received rituximab at the discretion of their treating physicians.
Interventions
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Rituximab
Participants received rituximab at the discretion of their treating physicians.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Known hypersensitivity to rituximab, to any component of the product, or to murine proteins
* Pregnant or breastfeeding women
* Diagnosis of Churg-Strauss syndrome
18 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Genentech, Inc.
Locations
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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
Countries
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References
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Merkel PA, Niles JL, Mertz LE, Lehane PB, Pordeli P, Erblang F. Long-Term Safety of Rituximab in Granulomatosis With Polyangiitis and in Microscopic Polyangiitis. Arthritis Care Res (Hoboken). 2021 Sep;73(9):1372-1378. doi: 10.1002/acr.24332. Epub 2021 Aug 13.
Other Identifiers
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WA27893
Identifier Type: -
Identifier Source: org_study_id
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