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
1 other identifier
observational
100
1 country
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2012
Longer than P75 for all trials
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 4, 2012
CompletedFirst Posted
Study publicly available on registry
June 7, 2012
CompletedStudy Start
First participant enrolled
June 20, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 13, 2015
CompletedResults Posted
Study results publicly available
August 17, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 28, 2017
CompletedJuly 26, 2018
July 1, 2018
3.1 years
June 4, 2012
July 6, 2016
July 24, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (9)
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)
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)
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)
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)
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)
- +4 more secondary outcomes
Study Arms (1)
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.
Interventions
Participants received rituximab at the discretion of their treating physicians.
Eligibility Criteria
Participants with granulomatosis with polyangiitis or microscopic polyangiitis treated with MabThera/Rituxan
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genentech, Inc.lead
Study Sites (15)
Mayo Clinic Arizona
Scottsdale, Arizona, 85025, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Mayo Clinic
Jacksonville, Florida, 32224, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Johns Hopkins Asthma&Allergy
Baltimore, Maryland, 21224, United States
Mass. General Hospital
Boston, Massachusetts, 02114, United States
Boston Medical Center
Boston, Massachusetts, 02118-2393, United States
Mayo Clinic Rochester; Int.Med - Div. of Pul
Rochester, Minnesota, 55905, United States
Weill Medical College of Cornell University; Hospital for Special Surgery
New York, New York, 10065, United States
UNC- Chapel Hill
Chapel Hill, North Carolina, 27516, United States
Duke Univ Medical Center
Durham, North Carolina, 27710, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44915, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261, United States
University of Utah; Division of Rheumatology
Salt Lake City, Utah, 84132, United States
Related Publications (1)
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.
PMID: 32475029DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffman-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Genentech, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 4, 2012
First Posted
June 7, 2012
Study Start
June 20, 2012
Primary Completion
July 13, 2015
Study Completion
April 28, 2017
Last Updated
July 26, 2018
Results First Posted
August 17, 2016
Record last verified: 2018-07