TriangleNCT01613599 · CITED IN SOURCE DOCUMENTS
An Observational Study of The Safety of MabThera/Rituxan (Rituximab) in Participants With Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- Not reported
- Status at capture
- COMPLETED
- Registry last update
- 2018-07-26
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.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Incidence Rate of Serious Infections
Percentage of Participants With a Serious Infusion-related Reaction
Incidence Rate of Serious Cardiac Adverse Events
Percentage of Participants With Any Serious Adverse Events During or Within 24 Hours After Any Rituximab Infusion
Incidence Rate of Serious Vascular Adverse Events
Incidence Rate of Malignancy, Excluding Non-melanoma Skin Cancer
Incidence Rate of Serious Adverse Events
Incidence Rate of Adverse Events With Fatal Outcomes
Incidence Rate of Serious Adverse Events in Participants Who Received Re-treatment With MabThera/Rituximab
Incidence Rate of Serious Infections in Participants Who Received Re-treatment With MabThera/Rituximab
Adverse events
Limitations, agreements, and source contact
Who could take part
- 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
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sampling Method
- NON_PROBABILITY_SAMPLE
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
- study Population
- Participants with granulomatosis with polyangiitis or microscopic polyangiitis treated with MabThera/Rituxan
Treatment arms and interventions
- arm Groups
- description
- 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.
- intervention Names
- Drug: Rituximab
- label
- Rituximab
- interventions
- arm Group Labels
- Rituximab
- description
- Participants received rituximab at the discretion of their treating physicians.
- name
- Rituximab
- other Names
- Rituxan
- type
- DRUG
Study design
- observational Model
- COHORT
- time Perspective
- PROSPECTIVE
Enrollment
- count
- 100
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- 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.
- measure
- Incidence Rate of Serious Infections
- time Frame
- From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years)
- secondary Outcomes
- description
- 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.
- measure
- Percentage of Participants With a Serious Infusion-related Reaction
- time Frame
- From the start of an infusion up to 24 hours following infusion completion (Up to 4.32 years)
- description
- 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.
- measure
- Incidence Rate of Serious Cardiac Adverse Events
- time Frame
- From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years)
- description
- 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.
- measure
- Percentage of Participants With Any Serious Adverse Events During or Within 24 Hours After Any Rituximab Infusion
- time Frame
- From the start of an infusion up to 24 hours following infusion completion (Up to 4.32 years)
- description
- 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.
- measure
- Incidence Rate of Serious Vascular Adverse Events
- time Frame
- From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years)
- description
- 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.
- measure
- Incidence Rate of Malignancy, Excluding Non-melanoma Skin Cancer
- time Frame
- From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years)
- description
- 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.
- measure
- Incidence Rate of Serious Adverse Events
- time Frame
- From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years)
- description
- Incidence rate is defined as events per 100 patient years.
- measure
- Incidence Rate of Adverse Events With Fatal Outcomes
- time Frame
- From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years)
- description
- 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.
- measure
- Incidence Rate of Serious Adverse Events in Participants Who Received Re-treatment With MabThera/Rituximab
- time Frame
- From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years)
- description
- 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.
- measure
- Incidence Rate of Serious Infections in Participants Who Received Re-treatment With MabThera/Rituximab
- time Frame
- From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years)
Full study description
- 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.
Source references
- 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.
- pmid
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- type
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Preserved source evidence · Not medical advice