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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: July 6, 2016
Last verified: July 2016
  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) ] [ Designated as safety issue: No ]

    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) ] [ Designated as safety issue: No ]

    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) ] [ Designated as safety issue: No ]

    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) ] [ Designated as safety issue: No ]

    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) ] [ Designated as safety issue: No ]

    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]

    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]

    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) ] [ Designated as safety issue: No ]

    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
Study Start Date: June 2012
Estimated Study Completion Date: May 2017
Primary Completion Date: July 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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
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

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01613599     History of Changes
Other Study ID Numbers: WA27893 
Study First Received: June 4, 2012
Results First Received: July 6, 2016
Last Updated: July 6, 2016
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 26, 2016