An Observational Study of The Safety of MabThera/Rituxan (Rituximab) in Participants With Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis
- Conditions
- Granulomatosis With PolyangiitisMicroscopic Polyangiitis
- Interventions
- Registration Number
- NCT01613599
- Lead Sponsor
- Genentech, Inc.
- 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 Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Rituximab 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.
- Primary Outcome Measures
Name Time Method Incidence Rate of Serious Infections From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years) 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With a Serious Infusion-related Reaction From the start of an infusion up to 24 hours following infusion completion (Up to 4.32 years) 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.
Incidence Rate of Serious Cardiac Adverse Events From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years) 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.
Incidence Rate of Serious Vascular Adverse Events From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years) 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.
Incidence Rate of Malignancy, Excluding Non-melanoma Skin Cancer From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years) 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.
Incidence Rate of Adverse Events With Fatal Outcomes From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years) 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 From the start of an infusion up to 24 hours following infusion completion (Up to 4.32 years) 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.
Incidence Rate of Serious Adverse Events From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years) 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.
Incidence Rate of Serious Adverse Events in Participants Who Received Re-treatment With MabThera/Rituximab From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years) 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.
Incidence Rate of Serious Infections in Participants Who Received Re-treatment With MabThera/Rituximab From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years) 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.
Trial Locations
- Locations (15)
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Johns Hopkins Asthma&Allergy
🇺🇸Baltimore, Maryland, United States
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Duke Univ Medical Center
🇺🇸Durham, North Carolina, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Mayo Clinic
🇺🇸Jacksonville, Florida, United States
Mass. General Hospital
🇺🇸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
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Mayo Clinic Arizona
🇺🇸Scottsdale, Arizona, United States
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
University of Utah; Division of Rheumatology
🇺🇸Salt Lake City, Utah, United States