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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01613599
First received: June 4, 2012
Last updated: November 4, 2014
Last verified: November 2014
  Purpose

This prospective observational study will evaluate the long-term safety of MabTh era/Rituxan (rituximab) in patients with granulomatosis with polyangiitis (Wegen er's) or microscopic polyangiitis. Data will be collected for a maximum of 4 yea rs from patients initiated on MabThera/Rituxan therapy by their physician accord ing to prescribing information.


Condition
Wegener's Granulomatosis, Microscopic Polyangiitis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective, Observational Safety Study of Patients With Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis Treated With Rituximab

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Safety: Incidence of serious infections (infections that are serious adverse events [SAEs] or non-SAE infections treated with iv antimicrobials) [ Time Frame: approximately 6 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety: Incidence of serious adverse events [ Time Frame: approximately 6 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of serious adverse events in patients who receive retreatment with MabThera/Rituxan [ Time Frame: approximately 6 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of serious infections in patients who receive retreatment with MabThera/Rituxan [ Time Frame: approximately 6 years ] [ Designated as safety issue: No ]
  • Safety: Proportion of patients experiencing serious infusion-related reactions [ Time Frame: approximately 6 years ] [ Designated as safety issue: No ]
  • Safety: Proportion of patients experiencing any serious adverse events during or within 24 hours after MabThera/Rituxan infusion [ Time Frame: approximately 6 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of serious cardiac adverse events [ Time Frame: approximately 6 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of serious vascular adverse events [ Time Frame: approximately 6 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of malignancy, excluding non-melanoma skin cancer [ Time Frame: approximately 6 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of fatal outcomes [ Time Frame: approximately 6 years ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: June 2012
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with granulomatosis with polyangiitis or microscopic polyangiitis treated with MabThera/Rituxan

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01613599

Locations
United States, Arizona
Scottsdale, Arizona, United States, 85025
United States, California
Los Angeles, California, United States, 90048
United States, Florida
Jacksonville, Florida, United States, 32224
United States, Illinois
Chicago, Illinois, United States, 60612
United States, Maryland
Baltimore, Maryland, United States, 21224
United States, Massachusetts
Boston, Massachusetts, United States, 02114
Boston, Massachusetts, United States, 02118-2393
United States, Minnesota
Rochester, Minnesota, United States, 55905
United States, New York
New York, New York, United States, 10065
United States, North Carolina
Chapel Hill, North Carolina, United States, 27516
Durham, North Carolina, United States, 27710
United States, Ohio
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Pittsburgh, Pennsylvania, United States, 15261
United States, Utah
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Clinical Trials Genentech, Inc.
  More Information

No publications provided

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01613599     History of Changes
Other Study ID Numbers: WA27893
Study First Received: June 4, 2012
Last Updated: November 4, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Wegener Granulomatosis
Microscopic Polyangiitis
Systemic Vasculitis
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Autoimmune Diseases
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebral Small Vessel Diseases
Cerebrovascular Disorders
Immune System Diseases
Lung Diseases
Lung Diseases, Interstitial
Nervous System Diseases
Respiratory Tract Diseases
Vascular Diseases
Vasculitis

ClinicalTrials.gov processed this record on November 27, 2014