An observational study in Granulomatosis With Polyangiitis and Microscopic Polyangiitis, sponsored by Genentech, Inc.. Completed at 15 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-26.
Sponsored by Genentech, Inc. (part of Hoffmann-La Roche) · Observational
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.
104 studies on the registry are indexed under Granulomatosis with Polyangiitis; 16 are open to participants now.
This study's enrollment of 100 is close to the median of 100 across 32 observational studies indexed under Granulomatosis with Polyangiitis.
Browse Granulomatosis with Polyangiitis studies →Genentech, Inc. is the lead sponsor of 517 studies on the registry; 20 are open to participants now.
Of its 95 completed or terminated interventional studies of FDA-regulated products, 52 (55%) have results posted.
First submitted after Genentech, Inc. became part of Hoffmann-La Roche.
Counted across the registry records on this site, refreshed daily.
Participants with granulomatosis with polyangiitis or microscopic polyangiitis treated with MabThera/Rituxan
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Also known as: Rituxan
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.
Time frame: From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years)
A total of 100 participants were enrolled in 15 investigational sites in United States. 3 participants out of 100 enrolled participants were not included in the analysis population as that site became unresponsive.
| Milestone | Rituximab |
|---|---|
| Started | 97 |
| Completed | 72 |
| Not completed | 25 |
| Withdrew: Death | 9 |
| Withdrew: Lost to follow-up | 5 |
| Withdrew: Withdrawal by subject | 8 |
| Withdrew: Reason not specified | 3 |
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.
| events per 100 patient year | Rituximab |
|---|---|
| Incidence Rate of Serious Infections | 7.11 (4.55 to 10.58) |
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.
| percentage of participants | Rituximab |
|---|---|
| Percentage of Participants With a Serious Infusion-related Reaction | 0 |
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.
| events per 100 patient year | Rituximab |
|---|---|
| Incidence Rate of Serious Cardiac Adverse Events | 5.03 (2.93 to 8.06) |
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.
| percentage of participants | Rituximab |
|---|---|
| Percentage of Participants With Any Serious Adverse Events During or Within 24 Hours After Any Rituximab Infusion | 0 |
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.
| events per 100 patient year | Rituximab |
|---|---|
| Incidence Rate of Serious Vascular Adverse Events | 2.37 (1.02 to 4.67) |
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.
| events per 100 patient year | Rituximab |
|---|---|
| Incidence Rate of Malignancy, Excluding Non-melanoma Skin Cancer | 0.89 (0.18 to 2.60) |
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.
| events per 100 patient year | Rituximab |
|---|---|
| Incidence Rate of Serious Adverse Events | 27.84 (22.50 to 34.07) |
Incidence rate is defined as events per 100 patient years.
| events per 100 patient year | Rituximab |
|---|---|
| Incidence Rate of Adverse Events With Fatal Outcomes | 2.67 (1.22 to 5.06) |
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.
| events per 100 patient year | Rituximab |
|---|---|
| Incidence Rate of Serious Adverse Events in Participants Who Received Re-treatment With MabThera/Rituximab | 23.90 (18.36 to 30.58) |
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.
| events per 100 patient year | Rituximab |
|---|---|
| Incidence Rate of Serious Infections in Participants Who Received Re-treatment With MabThera/Rituximab | 6.07 (3.47 to 9.86) |
Collected over Enrollment of the first participant to time of withdrawal or last participant visit (Up to 4.32 years). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Rituximab | 9/97 (9.3%) | 38/97 (39.2%) | 5/97 (5.2%) |
| Event | Rituximab |
|---|---|
| Atrial fibrillationCardiac disorders | 5/97 |
| Deep vein thrombosisVascular disorders | 5/97 |
| DeathGeneral disorders | 4/97 |
| GastroenteritisInfections and infestations | 2/97 |
| InfluenzaInfections and infestations | 2/97 |
| PneumoniaInfections and infestations | 2/97 |
| Staphylococcal bacteraemiaInfections and infestations | 2/97 |
| Herpes zosterInfections and infestations | 2/97 |
| Urinary tract infectionInfections and infestations | 2/97 |
| HaemoptysisRespiratory, thoracic and mediastinal disorders | 2/97 |
| Event | Rituximab |
|---|---|
| Throat irritationRespiratory, thoracic and mediastinal disorders | 5/97 |
The safety population included all participants who received any active dose of rituximab.
| Age, Continuous(years) | Rituximab |
|---|---|
| Mean | 56.3 ± 16.5 |
| Sex: Female, Male(Participants) | Rituximab |
|---|---|
| Female | 57 |
| Male | 40 |
Ran from Jun 2012 to primary completion in Jul 2015, 36 months.
Results were first posted in Aug 2016, 1 year 1 month after primary completion.
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This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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Granulomatosis with Polyangiitis →