Prospective, Observational Safety Study of Patients With Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis Treated With Rituximab
N/A
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Wegener's Granulomatosis, Microscopic Polyangiitis
Both
Wegener's Granulomatosis, Microscopic Polyangiitis
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 |
