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

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Brief Title

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

Official Title

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

Brief Summary

      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.
    



Study Type

Observational


Primary Outcome

Incidence Rate of Serious Infections

Secondary Outcome

 Percentage of Participants With a Serious Infusion-related Reaction

Condition

Granulomatosis With Polyangiitis

Intervention

Rituximab

Study Arms / Comparison Groups

 Rituximab
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

100

Start Date

June 20, 2012

Completion Date

April 28, 2017

Primary Completion Date

July 13, 2015

Eligibility Criteria

        Inclusion Criteria:

          -  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

        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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Clinical Trials, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01613599

Organization ID

WA27893


Responsible Party

Sponsor

Study Sponsor

Genentech, Inc.


Study Sponsor

Clinical Trials, Study Director, Genentech, Inc.


Verification Date

July 2018