Granulomatosis With PolyangiitisNCT01613599
An Observational Study of The Safety of MabThera/Rituxan (Rituximab) in Participants With Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis
An observational study of Granulomatosis With Polyangiitis and Microscopic Polyangiitis, run by Genentech, Inc. at 15 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Granulomatosis With Polyangiitis, Microscopic Polyangiitis
- What is being tested?
- Rituximab
- How many people
- 100 participants
- Where
- 15 sitesUnited States
- Study dates
- 20 Jun 2012to 28 Apr 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with granulomatosis with polyangiitis or microscopic polyangiitis treated with MabThera/Rituxan
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Johns Hopkins Asthma&Allergy
Baltimore, Maryland, 21224
Mass. General Hospital
Boston, Massachusetts, 02114
Boston Medical Center
Boston, Massachusetts, 02118-2393
UNC- Chapel Hill
Chapel Hill, North Carolina, 27516
Rush University Medical Center
Chicago, Illinois, 60612
Cleveland Clinic Foundation
Cleveland, Ohio, 44915
Duke Univ Medical Center
Durham, North Carolina, 27710
Mayo Clinic
Jacksonville, Florida, 32224
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Weill Medical College of Cornell University; Hospital for Special Surgery
New York, New York, 10065
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261
Mayo Clinic Rochester; Int.Med - Div. of Pul
Rochester, Minnesota, 55905
University of Utah; Division of Rheumatology
Salt Lake City, Utah, 84132
Mayo Clinic Arizona
Scottsdale, Arizona, 85025
About this study
Official title: Prospective, Observational Safety Study of Patients With Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis Treated With Rituximab
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.
- Being tested
- Rituximab
- Medical subject headings
- Granulomatosis with Polyangiitis, Microscopic Polyangiitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
Also called Rituxan
Participants received rituximab at the discretion of their treating physicians.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2012 (estimated)
- Study start20 Jun 2012
- Primary completion13 Jul 2015
- Study completion28 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Granulomatosis With PolyangiitisStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01613599
- Sponsor's protocol ID
- WA27893
- Status last verified
- Jul 2018
- First submitted
- 4 Jun 2012
- Last updated
- 26 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 32475029
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Observational Safety Study of Patients With Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis Treated With Rituximab
- ClinicalTrials.gov ID
- NCT01613599
- Acronym / sponsor ID
- WA27893
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Jun 2012 (actual)
- Primary completion
- 13 Jul 2015 (actual)
- Study completion
- 28 Apr 2017 (actual)
- First posted
- 7 Jun 2012 (estimated)
- Results
- Posted 17 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rituximab | – | Drug: RituximabParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with granulomatosis with polyangiitis or microscopic polyangiitis treated with MabThera/Rituxan
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RituximabAlso: RituxanParticipants received rituximab at the discretion of their treating physicians. | Drug | Rituximab |
Primary outcome
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)
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.
9 secondary outcomes
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)
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)
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)
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)
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)
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)
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)
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)
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32475029Merkel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Genentech, Inc.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Granulomatosis With Polyangiitis and Microscopic Polyangiitis, run by Genentech, Inc. at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01613599, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2018.