Clinical trial NCT01613599: An Observational Study of The Safety of MabThera/Rituxan (Rituximab) in Participants With Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis
Official title: Prospective, Observational Safety Study of Patients With Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis Treated With Rituximab
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Granulomatosis With Polyangiitis
Microscopic Polyangiitis
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2012-06-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with granulomatosis with polyangiitis or microscopic polyangiitis treated with MabThera/Rituxan

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence Rate of Serious Infections
timeFrame: From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years)
Secondary outcomes:
measure: Percentage of Participants With a Serious Infusion-related Reaction
timeFrame: From the start of an infusion up to 24 hours following infusion completion (Up to 4.32 years)
measure: Incidence Rate of Serious Cardiac Adverse Events
timeFrame: From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years)
measure: Percentage of Participants With Any Serious Adverse Events During or Within 24 Hours After Any Rituximab Infusion
timeFrame: From the start of an infusion up to 24 hours following infusion completion (Up to 4.32 years)
measure: Incidence Rate of Serious Vascular Adverse Events
timeFrame: From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years)
measure: Incidence Rate of Malignancy, Excluding Non-melanoma Skin Cancer
timeFrame: From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years)
measure: Incidence Rate of Serious Adverse Events
timeFrame: From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years)
measure: Incidence Rate of Adverse Events With Fatal Outcomes
timeFrame: From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years)
measure: Incidence Rate of Serious Adverse Events in Participants Who Received Re-treatment With MabThera/Rituximab
timeFrame: From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years)
measure: Incidence Rate of Serious Infections in Participants Who Received Re-treatment With MabThera/Rituximab
timeFrame: From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years)
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins Asthma&Allergy
state: Maryland
city: Boston
country: United States
facility: Mass. General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic Rochester; Int.Med - Div. of Pul
state: Minnesota
city: New York
country: United States
facility: Weill Medical College of Cornell University; Hospital for Special Surgery
state: New York
city: Chapel Hill
country: United States
facility: UNC- Chapel Hill
state: North Carolina
city: Durham
country: United States
facility: Duke Univ Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Salt Lake City
country: United States
facility: University of Utah; Division of Rheumatology
state: Utah
Study officials:
affiliation: Genentech, Inc.
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.