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

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

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 Overview

• Status: Completed
• Conditions: Microscopic Polyangiitis; Granulomatosis With Polyangiitis
• Intervention / Treatment: Drug: Rituximab

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85025
      • Mayo Clinic Arizona
  • California
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Johns Hopkins Asthma&Allergy
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Mass. General Hospital
    • Boston, Massachusetts, United States, 02118-2393
      • Boston Medical Center
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Rochester; Int.Med - Div. of Pul
  • New York
    • New York, New York, United States, 10065
      • Weill Medical College of Cornell University; Hospital for Special Surgery
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27516
      • UNC- Chapel Hill
    • Durham, North Carolina, United States, 27710
      • Duke Univ Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44915
      • Cleveland Clinic Foundation
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • UNIVERSITY of PENNSYLVANIA
    • Pittsburgh, Pennsylvania, United States, 15261
      • University of Pittsburgh
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah; Division of Rheumatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants with granulomatosis with polyangiitis or microscopic polyangiitis treated with MabThera/Rituxan

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: Rituximab; Participants received rituximab at the discretion of their treating physicians.; Other Names: Rituxan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: Genentech, Inc.

Publications and helpful links

General Publications

• Merkel PA, Niles JL, Mertz LE, Lehane PB, Pordeli P, Erblang F. Long-Term Safety of Rituximab in Granulomatosis With Polyangiitis and in Microscopic Polyangiitis. Arthritis Care Res (Hoboken). 2021 Sep;73(9):1372-1378. doi: 10.1002/acr.24332. Epub 2021 Aug 13.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 20, 2012
• Primary Completion (ACTUAL): July 13, 2015
• Study Completion (ACTUAL): April 28, 2017

Study Registration Dates

• First Submitted: June 4, 2012
• First Submitted That Met QC Criteria: June 6, 2012
• First Posted (ESTIMATE): June 7, 2012

Study Record Updates

• Last Update Posted (ACTUAL): July 26, 2018
• Last Update Submitted That Met QC Criteria: July 24, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Respiratory Tract Diseases; Immune System Diseases; Autoimmune Diseases; Lung Diseases; Vasculitis; Lung Diseases, Interstitial; Cerebral Small Vessel Diseases; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Granulomatosis with Polyangiitis; Microscopic Polyangiitis; Systemic Vasculitis; Physiological Effects of Drugs; Antirheumatic Agents; Antineoplastic Agents; Immunologic Factors; Antineoplastic Agents, Immunological; Rituximab
• Other Study ID Numbers: WA27893