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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

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.

Detailed Summary:
Sponsor: Genentech, Inc.

Current Primary Outcome: 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.



Original Primary Outcome: 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 ]

Current Secondary Outcome:

  • 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 dea

      Original Secondary Outcome:

      • Safety: Incidence of serious adverse events [ Time Frame: approximately 6 years ]
      • Safety: Incidence of serious adverse events in patients who receive retreatment with MabThera/Rituxan [ Time Frame: approximately 6 years ]
      • Safety: Incidence of serious infections in patients who receive retreatment with MabThera/Rituxan [ Time Frame: approximately 6 years ]
      • Safety: Proportion of patients experiencing serious infusion-related reactions [ Time Frame: approximately 6 years ]
      • Safety: Proportion of patients experiencing any serious adverse events during or within 24 hours after MabThera/Rituxan infusion [ Time Frame: approximately 6 years ]
      • Safety: Incidence of serious cardiac adverse events [ Time Frame: approximately 6 years ]
      • Safety: Incidence of serious vascular adverse events [ Time Frame: approximately 6 years ]
      • Safety: Incidence of malignancy, excluding non-melanoma skin cancer [ Time Frame: approximately 6 years ]
      • Safety: Incidence of fatal outcomes [ Time Frame: approximately 6 years ]


      Information By: Genentech, Inc.

      Dates:
      Date Received: June 4, 2012
      Date Started: June 20, 2012
      Date Completion: May 19, 2017
      Last Updated: April 5, 2017
      Last Verified: April 2017