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
Enrollment
100
Participants received rituximab at the discretion of their treating physicians.
Mayo Clinic Arizona
Scottsdale, Arizona, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Incidence Rate of Serious Infections
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. A 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.
Time frame: From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years)
Percentage of Participants With a Serious Infusion-related Reaction
A serious infusion-related reaction was defined as a SAE during or within 24 hours after any rituximab infusion and considered infusion related by the Principal Investigator. A 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.
Time frame: From the start of an infusion up to 24 hours following infusion completion (Up to 4.32 years)
Incidence Rate of Serious Cardiac Adverse Events
A serious cardiac adverse event was defined as a SAE that was coded to the Medical Dictionary for Regulatory Activities (MedDRA) cardiac system organ class. A 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.
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Mayo Clinic
Jacksonville, Florida, United States
Rush University Medical Center
Chicago, Illinois, United States
Johns Hopkins Asthma&Allergy
Baltimore, Maryland, United States
Mass. General Hospital
Boston, Massachusetts, United States
Boston Medical Center
Boston, Massachusetts, United States
Mayo Clinic Rochester; Int.Med - Div. of Pul
Rochester, Minnesota, United States
Weill Medical College of Cornell University; Hospital for Special Surgery
New York, New York, United States
UNC- Chapel Hill
Chapel Hill, North Carolina, United States
...and 5 more locations
Time frame: From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years)
Percentage of Participants With Any Serious Adverse Events During or Within 24 Hours After Any Rituximab Infusion
A 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.
Time frame: From the start of an infusion up to 24 hours following infusion completion (Up to 4.32 years)
Incidence Rate of Serious Vascular Adverse Events
A serious vascular adverse event was defined as a SAE coded to the MedDRA vascular system organ class. A 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.
Time frame: From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years)
Incidence Rate of Malignancy, Excluding Non-melanoma Skin Cancer
Malignancies were clinical findings of cancer and excluded non-melanoma skin cancer. 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.
Time frame: From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years)
Incidence Rate of Serious Adverse Events
A 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.
Time frame: From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years)
Incidence Rate of Adverse Events With Fatal Outcomes
Incidence rate is defined as events per 100 patient years.
Time frame: From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years)
Incidence Rate of Serious Adverse Events in Participants Who Received Re-treatment With MabThera/Rituximab
A 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.
Time frame: From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years)
Incidence Rate of Serious Infections in Participants Who Received Re-treatment With MabThera/Rituximab
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. A 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.
Time frame: From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years)