Trial · NCT01613599
An Observational Study of The Safety of MabThera/Rituxan (Rituximab) in Participants With Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis
NCT01613599, Completed, Genentech, Inc.; results first posted 2016-08-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Observational Study of The Safety of MabThera/Rituxan (Rituximab) in Participants With Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis. Trials, record NCT01613599. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01613599
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Observational Study of The Safety of MabThera/Rituxan (Rituximab) in Participants With Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis
- NCT number
- NCT01613599
- Status
- Completed
- Enrollment
- 100 participants, actual
- Lead sponsor
- Genentech, Inc.
- Conditions
- Granulomatosis With Polyangiitis, Microscopic Polyangiitis
- Interventions
- Rituximab
- First posted
- 2012-06-07
- Last updated
- 2018-07-26
- Results first posted
- 2016-08-17
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence Rate of Serious Infections | From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years) | 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. |
| Secondary | 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) | 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. |
| Secondary | 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) | 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. |
| Secondary | 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) | 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. |
| Secondary | 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) | 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. |
| Secondary | 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) | 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. |
| Secondary | Incidence Rate of Serious Adverse Events | From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years) | 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. |
| Secondary | Incidence Rate of Adverse Events With Fatal Outcomes | From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years) | Incidence rate is defined as events per 100 patient years. |
| Secondary | Incidence Rate of Serious Adverse Events in Participants Who Received Re-treatment With MabThera/Rituximab | From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years) | 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. |
| Secondary | Incidence Rate of Serious Infections in Participants Who Received Re-treatment With MabThera/Rituximab | From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years) | 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. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence Rate of Serious Infections | From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years) | The safety population included all participants who received any active dose of rituximab. | events per 100 patient year | NUMBER |
| SECONDARY | 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) | The safety population included all participants who received any active dose of rituximab. | percentage of participants | NUMBER |
| SECONDARY | 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) | The safety population included all participants who received any active dose of rituximab. | events per 100 patient year | NUMBER |
| SECONDARY | 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) | The safety population included all participants who received any active dose of rituximab. | percentage of participants | NUMBER |
| SECONDARY | 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) | The safety population included all participants who received any active dose of rituximab. | events per 100 patient year | NUMBER |
| SECONDARY | 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) | The safety population included all participants who received any active dose of rituximab. | events per 100 patient year | NUMBER |
| SECONDARY | Incidence Rate of Serious Adverse Events | From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years) | The safety population included all participants who received any active dose of rituximab. | events per 100 patient year | NUMBER |
| SECONDARY | Incidence Rate of Adverse Events With Fatal Outcomes | From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years) | The safety population included all participants who received any active dose of rituximab. | events per 100 patient year | NUMBER |
| SECONDARY | Incidence Rate of Serious Adverse Events in Participants Who Received Re-treatment With MabThera/Rituximab | From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years) | The re-treated safety population was a subset of the safety population and included all participants who received more than one course of rituximab. | events per 100 patient year | NUMBER |
| SECONDARY | Incidence Rate of Serious Infections in Participants Who Received Re-treatment With MabThera/Rituximab | From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years) | The re-treated safety population was a subset of the safety population and included all participants who received more than one course of rituximab. | events per 100 patient year | NUMBER |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence Rate of Serious Infections | Rituximab | 7.11 | 95% Confidence Interval 4.55 to 10.58 | events per 100 patient year | |
| Percentage of Participants With a Serious Infusion-related Reaction | Rituximab | 0 | percentage of participants | ||
| Incidence Rate of Serious Cardiac Adverse Events | Rituximab | 5.03 | 95% Confidence Interval 2.93 to 8.06 | events per 100 patient year | |
| Percentage of Participants With Any Serious Adverse Events During or Within 24 Hours After Any Rituximab Infusion | Rituximab | 0 | percentage of participants | ||
| Incidence Rate of Serious Vascular Adverse Events | Rituximab | 2.37 | 95% Confidence Interval 1.02 to 4.67 | events per 100 patient year | |
| Incidence Rate of Malignancy, Excluding Non-melanoma Skin Cancer | Rituximab | 0.89 | 95% Confidence Interval 0.18 to 2.60 | events per 100 patient year | |
| Incidence Rate of Serious Adverse Events | Rituximab | 27.84 | 95% Confidence Interval 22.50 to 34.07 | events per 100 patient year | |
| Incidence Rate of Adverse Events With Fatal Outcomes | Rituximab | 2.67 | 95% Confidence Interval 1.22 to 5.06 | events per 100 patient year | |
| Incidence Rate of Serious Adverse Events in Participants Who Received Re-treatment With MabThera/Rituximab | Rituximab | 23.90 | 95% Confidence Interval 18.36 to 30.58 | events per 100 patient year | |
| Incidence Rate of Serious Infections in Participants Who Received Re-treatment With MabThera/Rituximab | Rituximab | 6.07 | 95% Confidence Interval 3.47 to 9.86 | events per 100 patient year |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Rituximab | 97 | |
| Overall Study | COMPLETED | Rituximab | 72 | |
| Overall Study | NOT COMPLETED | Rituximab | 25 |
Source ClinicalTrials.gov
Adverse events65
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Throat irritation | Respiratory, thoracic and mediastinal disorders | Rituximab | 5 | 97 | |
| serious | Gastroenteritis | Infections and infestations | Rituximab | 2 | 97 | |
| serious | Influenza | Infections and infestations | Rituximab | 2 | 97 | |
| serious | Pneumonia | Infections and infestations | Rituximab | 2 | 97 | |
| serious | Staphylococcal bacteraemia | Infections and infestations | Rituximab | 2 | 97 | |
| serious | Bacteraemia | Infections and infestations | Rituximab | 1 | 97 | |
| serious | Bronchitis | Infections and infestations | Rituximab | 1 | 97 | |
| serious | Cellulitis | Infections and infestations | Rituximab | 1 | 97 | |
| serious | Endocarditis | Infections and infestations | Rituximab | 1 | 97 | |
| serious | Herpes zoster | Infections and infestations | Rituximab | 2 | 97 |
1 to 10 of 65Source ClinicalTrials.gov
See all 65 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rituximab | 9 | 97 |
| Total, other adverse events | Rituximab | 5 | 97 |
| Total, serious adverse events | Rituximab | 38 | 97 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32475029 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01613599
GET https://conductscience.org/api/trials/v1/NCT01613599/events?page=2