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Prospective, Observational Safety Study of Patients With Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis Treated With Rituximab


N/A
18 Years
N/A
Open (Enrolling)
Both
Wegener's Granulomatosis, Microscopic Polyangiitis

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Trial Information

Prospective, Observational Safety Study of Patients With Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis Treated With Rituximab


Inclusion Criteria:



- Adult patients, >/= 18 years of age

- Granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA), according
to Chapel Hill Consensus Conference Definitions for MPA and 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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Safety: Incidence of serious infections (infections that are serious adverse events [SAEs] or non-SAE infections treated with iv antimicrobials)

Outcome Time Frame:

approximately 6 years

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

United States: Food and Drug Administration

Study ID:

WA27893

NCT ID:

NCT01613599

Start Date:

June 2012

Completion Date:

April 2018

Related Keywords:

  • Wegener's Granulomatosis, Microscopic Polyangiitis
  • Wegener Granulomatosis
  • Systemic Vasculitis
  • Microscopic Polyangiitis

Name

Location
Hinsdale, Illinois  60521
Alexandria, Minnesota  56308
Phoenix, Arizona  85012
Fountain Valley, California  92708
Miami, Florida  33176
Albany, New York  12208
Cleveland, Ohio  44195
Philadelphia, Pennsylvania  19104
Boston, Massachusetts  
Charlotte, North Carolina  
Salt Lake City, Utah  84112