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

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Genentech, Inc.
Study ID
NCT01613599
Status
Completed

Conditions

  • Granulomatosis With Polyangiitis
  • Microscopic Polyangiitis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    Participants received rituximab at the discretion of their treating physicians.

Study Details

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 Dates

Start date
Jun 20, 2012
Status verified
Jul 2018
Primary completion
Jul 13, 2015
Completion
Apr 28, 2017

Study Design

Enrollment
100 participants (actual)

Arms

  • Arm: 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.

Primary Outcome Measure

Incidence Rate of Serious Infections [ Time Frame: From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years) ]

Locations (15)

FacilityCityStateZIPSite coordinators
Mayo Clinic ArizonaScottsdaleArizona85025-
Cedars-Sinai Medical CenterLos AngelesCalifornia90048-
Mayo ClinicJacksonvilleFlorida32224-
Rush University Medical CenterChicagoIllinois60612-
Johns Hopkins Asthma&AllergyBaltimoreMaryland21224-
Boston Medical CenterBostonMassachusetts02118-2393-
Mass. General HospitalBostonMassachusetts02114-
Mayo Clinic Rochester; Int.Med - Div. of PulRochesterMinnesota55905-
Weill Medical College of Cornell University; Hospital for Special SurgeryNew YorkNew York10065-
UNC- Chapel HillChapel HillNorth Carolina27516-
Duke Univ Medical CenterDurhamNorth Carolina27710-
Cleveland Clinic FoundationClevelandOhio44915-
University of PennsylvaniaPhiladelphiaPennsylvania19104-
University of PittsburghPittsburghPennsylvania15261-
University of Utah; Division of RheumatologySalt Lake CityUtah84132-

Find similar trials in Scottsdale, AZ

By research site
Mayo Clinic Arizona· Scottsdale, AZCedars-Sinai Medical Center· Los Angeles, CAMayo Clinic· Jacksonville, FLRush University Medical Center· Chicago, ILJohns Hopkins Asthma&Allergy· Baltimore, MDBoston Medical Center· Boston, MA

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