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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01613599
Other study ID # WA27893
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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)
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