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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 has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01613599
First Posted: June 7, 2012
Last Update Posted: August 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Genentech, Inc.
  Purpose
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.

Condition Intervention
Granulomatosis With Polyangiitis Microscopic Polyangiitis Drug: Rituximab

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:
  • Incidence Rate of Serious Infections [ Time Frame: From first dose until participant withdrawal or the date of latest participant visit (up to 37 months) ]

    A serious infection was defined as an infection that was a serious adverse event (SAE) or a non-SAE infection that required treatment with intravenous antimicrobials. An SAE was defined as any adverse event that fulfilled at least one of the following criteria:

    • Was fatal (results in death)
    • Was life-threatening
    • Required in-patient hospitalization or prolongation of existing hospitalization
    • Resulted in persistent or significant disability/incapacity
    • Was a congenital anomaly/birth defect
    • Was medically significant or required intervention to prevent one or other of the outcomes listed above.

    Multiple events reported in the same participant were counted multiple times in the calculation of incidence. Incidence rate is defined as events per 100 patient years.



Secondary Outcome Measures:
  • Percentage of Participants With a Serious Infusion-related Reaction [ Time Frame: From the start of an infusion up to 24 hours following infusion completion (up to 37 months) ]

    A serious infusion-related reaction was defined as an SAE during or within 24 hours after any rituximab infusion and considered infusion related by the Principal Investigator. An SAE was defined as any adverse event that fulfilled at least one of the following criteria:

    • Was fatal (results in death)
    • Was life-threatening
    • Required in-patient hospitalization or prolongation of existing hospitalization
    • Resulted in persistent or significant disability/incapacity
    • Was a congenital anomaly/birth defect
    • Was medically significant or required intervention to prevent one or other of the outcomes listed above.

  • Incidence Rate of Serious Cardiac Adverse Events [ Time Frame: From first dose until participant withdrawal or the date of latest participant visit (up to 37 months) ]

    A serious cardiac adverse event was defined as an SAE that was coded to the Medical Dictionary for Regulatory Activities (MedDRA) cardiac system organ class. An SAE was defined as any adverse event that fulfilled at least one of the following criteria:

    • Was fatal (results in death)
    • Was life-threatening
    • Required in-patient hospitalization or prolongation of existing hospitalization
    • Resulted in persistent or significant disability/incapacity
    • Was a congenital anomaly/birth defect
    • Was medically significant or required intervention to prevent one or other of the outcomes listed above.

    Multiple events reported in the same participant were counted multiple times in the calculation of incidence. Incidence rate is defined as events per 100 patient years.


  • Percentage of Participants With Any Serious Adverse Events During or Within 24 Hours After Any Rituximab Infusion [ Time Frame: From the start of an infusion up to 24 hours following infusion completion (up to 37 months) ]

    An SAE was defined as any adverse event that fulfilled at least one of the following criteria:

    • Was fatal (results in death)
    • Was life-threatening
    • Required in-patient hospitalization or prolongation of existing hospitalization
    • Resulted in persistent or significant disability/incapacity
    • Was a congenital anomaly/birth defect
    • Was medically significant or required intervention to prevent one or other of the outcomes listed above.

  • Incidence Rate of Serious Vascular Adverse Events [ Time Frame: From first dose until participant withdrawal or the date of latest participant visit (up to 37 months) ]

    A serious vascular adverse event was defined as an SAE coded to the MedDRA vascular system organ class. An SAE was defined as any adverse event that fulfilled at least one of the following criteria:

    • Was fatal (results in death)
    • Was life-threatening
    • Required in-patient hospitalization or prolongation of existing hospitalization
    • Resulted in persistent or significant disability/incapacity
    • Was a congenital anomaly/birth defect
    • Was medically significant or required intervention to prevent one or other of the outcomes listed above.

    Multiple events reported in the same participant were counted multiple times in the calculation of incidence. Incidence rate is defined as events per 100 patient years.


  • Incidence Rate of Malignancy, Excluding Non-melanoma Skin Cancer [ Time Frame: From first dose until participant withdrawal or the date of latest participant visit (up to 37 months) ]
    Multiple events reported in the same participant were counted multiple times in the calculation of incidence. Incidence rate is defined as events per 100 patient years.

  • Incidence Rate of Serious Adverse Events [ Time Frame: From first dose until participant withdrawal or the date of latest participant visit (up to 37 months) ]

    An SAE was defined as any adverse event that fulfilled at least one of the following criteria:

    • Was fatal (results in death)
    • Was life-threatening
    • Required in-patient hospitalization or prolongation of existing hospitalization
    • Resulted in persistent or significant disability/incapacity
    • Was a congenital anomaly/birth defect
    • Was medically significant or required intervention to prevent one or other of the outcomes listed above.

    Multiple events reported in the same participant were counted multiple times in the calculation of incidence. Incidence rate is defined as events per 100 patient years.


  • Incidence Rate of Adverse Events With Fatal Outcomes [ Time Frame: From first dose until participant withdrawal or the date of latest participant visit (up to 37 months) ]
    Incidence rate is defined as events per 100 patient years.

  • Incidence Rate of Serious Adverse Events in Participants Who Received Re-treatment With MabThera/Rituximab [ Time Frame: From first dose until participant withdrawal or the date of latest participant visit (up to 37 months) ]

    An SAE was defined as any adverse event that fulfilled at least one of the following criteria:

    • Was fatal (results in death)
    • Was life-threatening
    • Required in-patient hospitalization or prolongation of existing hospitalization
    • Resulted in persistent or significant disability/incapacity
    • Was a congenital anomaly/birth defect
    • Was medically significant or required intervention to prevent one or other of the outcomes listed above.

    Multiple events reported in the same participant were counted multiple times in the calculation of incidence. Incidence rate is defined as events per 100 patient years.


  • Incidence Rate of Serious Infections in Participants Who Received Re-treatment With MabThera/Rituximab [ Time Frame: From first dose until participant withdrawal or the date of latest participant visit (up to 37 months) ]

    A serious infection was defined as an infection that was a serious adverse event (SAE) or a non-SAE infection that required treatment with intravenous antimicrobials. An SAE was defined as any adverse event that fulfilled at least one of the following criteria:

    • Was fatal (results in death)
    • Was life-threatening
    • Required in-patient hospitalization or prolongation of existing hospitalization
    • Resulted in persistent or significant disability/incapacity
    • Was a congenital anomaly/birth defect
    • Was medically significant or required intervention to prevent one or other of the outcomes listed above.

    Multiple events reported in the same participant were counted multiple times in the calculation of incidence. Incidence rate is defined as events per 100 patient years.



Enrollment: 100
Actual Study Start Date: June 20, 2012
Study Completion Date: April 28, 2017
Primary Completion Date: July 13, 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Drug: Rituximab
Participants received rituximab at the discretion of their treating physicians.
Other Name: Rituxan

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants with granulomatosis with polyangiitis or microscopic polyangiitis treated with MabThera/Rituxan
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01613599


Locations
United States, Arizona
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85025
United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Maryland
Johns Hopkins Asthma&Allergy
Baltimore, Maryland, United States, 21224
United States, Massachusetts
Mass. General Hospital
Boston, Massachusetts, United States, 02114
Boston Medical Center
Boston, Massachusetts, United States, 02118-2393
United States, Minnesota
Mayo Clinic Rochester; Int.Med - Div. of Pul
Rochester, Minnesota, United States, 55905
United States, New York
Weill Medical College of Cornell University; Hospital for Special Surgery
New York, New York, United States, 10065
United States, North Carolina
UNC- Chapel Hill
Chapel Hill, North Carolina, United States, 27516
Duke Univ Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15261
United States, Utah
University of Utah; Division of Rheumatology
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Clinical Trials Genentech, Inc.
  More Information

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01613599     History of Changes
Other Study ID Numbers: WA27893
First Submitted: June 4, 2012
First Posted: June 7, 2012
Results First Submitted: July 6, 2016
Results First Posted: August 17, 2016
Last Update Posted: August 14, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Granulomatosis with Polyangiitis
Systemic Vasculitis
Microscopic Polyangiitis
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Autoimmune Diseases
Immune System Diseases
Cerebral Small Vessel Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Rituximab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents