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

Microscopic Polyangiitis Clinical Trial

Official title:

Prospective, Observational Safety Study of Patients With Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis Treated With Rituximab

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01613599
• Other study ID #: WA27893
• Status: Completed
• Start date: June 20, 2012
• Est. completion date: April 28, 2017

Study information

• Verified date: July 2018
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 28, 2017
• Est. primary completion date: July 13, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Granulomatosis With Polyangiitis
• Microscopic Polyangiitis
• Systemic Vasculitis

Intervention

Drug:
• Rituximab
Participants received rituximab at the discretion of their treating physicians.

Locations

Country	Name	City	State
United States	Johns Hopkins Asthma&Allergy	Baltimore	Maryland
United States	Boston Medical Center	Boston	Massachusetts
United States	Mass. General Hospital	Boston	Massachusetts
United States	UNC- Chapel Hill	Chapel Hill	North Carolina
United States	Rush University Medical Center	Chicago	Illinois
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Duke Univ Medical Center	Durham	North Carolina
United States	Mayo Clinic	Jacksonville	Florida
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Weill Medical College of Cornell University; Hospital for Special Surgery	New York	New York
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Mayo Clinic Rochester; Int.Med - Div. of Pul	Rochester	Minnesota
United States	University of Utah; Division of Rheumatology	Salt Lake City	Utah
United States	Mayo Clinic Arizona	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years)
Secondary	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.	From the start of an infusion up to 24 hours following infusion completion (Up to 4.32 years)
Secondary	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.	From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years)
Secondary	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.	From the start of an infusion up to 24 hours following infusion completion (Up to 4.32 years)
Secondary	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.	From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years)
Secondary	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.	From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years)
Secondary	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.	From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years)
Secondary	Incidence Rate of Adverse Events With Fatal Outcomes	Incidence rate is defined as events per 100 patient years.	From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years)
Secondary	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.	From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years)
Secondary	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.	From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years)