Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Microscopic Polyangiitis, Wegener Granulomatosis
Conditions
Keywords
vasculitis, ANCA vasculitis, microscopic polyangiitis, granulomatosis, Wegener's, AAV, vasculitides
Brief summary
Rituximab is now established as an effective drug for anti-neutrophil cytoplasmic antibody (ANCA) vasculitis following major European and US trials reported in 2010. After a time, its effect wears off and the disease can return. This occurs in at least half of patients within 2 years of receiving Rituximab. A preliminary study in Cambridge has suggested that repeating rituximab every six months stops the disease returning and is safe. The RITAZAREM trial will find out whether repeating rituximab stops vasculitis returning and whether it works better than the older treatments, azathioprine or methotrexate. It will also tell us how long patients remain well after the repeated rituximab treatments are stopped, and if repeated rituximab is safe. We should also learn useful information about the effects of rituximab on quality of life and economic measures. The trial results will help decide the best treatment for future patients who have their vasculitis initially treated with rituximab. RITAZAREM aims to recruit patients with established ANCA vasculitis whose disease has come back 'relapsing vasculitis'. All patients will be treated with rituximab and steroids and we anticipate that most will respond well. If their disease is under reasonable control after four months, further treatment with either rituximab (a single dose ever four months for two years) or azathioprine tablets will be chosen randomly. The patients in the rituximab and azathioprine groups will then be compared. Patients will be in the trial for four years. The study has been designed by members of the European Vasculitis Study group (EUVAS) and the Vasculitis Clinical Research Consortium (VCRC). It will include 190 participants from 30 hospitals in Europe, the USA, Australia and Mexico. RITAZAREM is being funded by Arthritis Research UK, the U.S. National Institutes of Health and by Roche/Genentech.
Detailed description
Patients will be recruited at the time of relapse. All will receive rituximab 375 mg/m2/week x 4 and glucocorticoids. Those patients that achieve disease control (BVAS/WG ≤ 1 and daily prednisone dose ≤ 10 mg) by month 4 will be randomised to the rituximab or control remission maintenance groups. Treatment is protocolised for the entire duration of the study, until the common close date, when the final patient recruited has completed 36 months within the study or until the patient has completed 48 months on study whichever the sooner. Patients in the rituximab arm will receive treatment until month 20, and those in the azathioprine arm until month 27.
Interventions
BIOLOGICALRituximab
Rituximab IV infusion 1000 mg x 1 dose at months 4, 8, 12, 16 and 20 and glucocorticoids. Four - six hour infusion. Treatment with rituximab will cease at month 20.
DRUGAzathioprine
Oral dosage form. Target dose is 2mg/kg; maximum daily dose is 200mg. This should be continued until month 24. The dose should then by reduced by 50% and azathioprine completely withdrawn at month 27. The dose should be rounded down to the nearest 25mg. The dose may vary on alternate days e.g. 100mg one day, 150mg the next for patients on an overall dose of 125mg daily. If patients are aged over 60 years, reduce the dose by 25%. If patients are aged over 75 years, reduce the dose by 50%.
Sponsors
Arthritis Research UK
Roche Pharma AG
Genentech, Inc.
University of Pennsylvania
Cambridge University Hospitals NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. A diagnosis of AAV \[granulomatosis with polyangiitis or microscopic polyangiitis\], according to the definitions of the Chapel Hill Consensus Conference 2. Current or historical PR3/MPO ANCA positivity by ELISA 3. Disease relapse defined by one major or three minor disease activity items on the Birmingham Vasculitis Activity Score for Wegeners (BVAS/WG), in patients that have previously achieved remission following at least 3 months of induction therapy, with a combination of glucocorticoids and an immunosuppressive agent (cyclophosphamide or methotrexate or rituximab or mycophenolate mofetil) 4. Written informed consent
Exclusion criteria
1. Age \< 15 years (age \< 18 years at centres that do not treat paediatric patients) 2. Exclusions related to medication: Previous therapy with: 1. Any biological B cell depleting agent (such as rituximab or belimumab) within the past 6 months 2. Alemtuzumab or anti-thymocyte globulin (ATG) within the last 12 months 3. IVIg, infliximab, etanercept, adalimumab, abatacept or plasma exchange in past 3 months 4. Any investigational agent within 28 days of screening, or 5 half lives of the investigational drug (whichever is longer) 3. Exclusions related to general health: 1. Significant or uncontrolled medical disease not related to AAV, which in the investigators opinion would preclude patient participation 2. Presence of another multisystem autoimmune disease, including Churg Strauss syndrome, systemic lupus erythematosus, anti-GBM disease, or cryoglobulinaemic vasculitis, 3. Any concomitant condition anticipated to likely require greater than 4 weeks per year of oral or systemic glucocorticoid use and which would preclude compliance with the glucocorticoid protocol (e.g. poorly-controlled asthma, COPD, psoriasis, or inflammatory bowel disease). 4. History of severe allergic or anaphylactic reactions to humanised or murine chimeric monoclonal antibodies 5. Known infection with HIV (HIV testing will not be a requirement for trial entry); a past or current history of hepatitis B virus or hepatitis C virus infection. 6. Ongoing or recent (last 12 months) evidence of active tuberculosis or known active infection (screening for tuberculosis is part of standard of care in patients with established AAV) or evidence of untreated latent tuberculosis. Screening for tuberculosis is as per local practice. 7. History of malignancy within the past five years or any evidence of persistent malignancy, except fully excised basal cell or squamous cell carcinomas of the skin, or cervical carcinoma in situ which has been treated or excised in a curative procedure. 8. Pregnancy or inadequate contraception in pre-menopausal women 9. Breast feeding or lactating 4.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relapse-free Survival | Any patients who have not relapsed at up to a maximum of 4 years will be censored. | The primary efficacy outcome measure of the trial is relapse-free survival, where a relapse is either major or minor. The primary analysis will be a Cox regression model adjusted for the stratification factors (ANCA type, relapse severity and prednisone induction regimen) for the difference in the distribution of relapse-free survival between the rituximab arm and the azathioprine (control) arm (two-sided at α-level of 5%). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Combined Damage Assessment Score (Disease Related Damage Assessment) | data in Rows represent the change from randomization (month 4) to months 12, 24, 36, and 48. | Cumulative accrual of damage as measured by the combined damage assessment score (CDA). Each persistent or new occurrence of damage is given a score of 1. The cumulative accrual of damage is obtained by summing across the different types of damage to get an overall score (max score = 64). |
| Cumulative GC Exposure | Up to 48 months | Cumulative glucocorticoid (GC) exposure during the trial. The trial had a common close out date when the final patient reached month 36 in the trial. Patients were followed until month 48 or the common close out date, whichever happened sooner. Therefore, follow up varied between 36 and 48 months. Cumulative glucocorticoid exposure is presented as a dose in mg for during the treatment period (up to month 24) and across the whole trial (until month 48 or common close out when the final patient reached month 36). |
| Severe Adverse Event Rate | Up to 48 months | Severe adverse event (SAE) rate |
| Number of Participants in Remission at 24 and 48 Months | 24 and 48 months | Proportion of patients who maintain remission at 24 and 48 months |
| Health-related Quality of Life Using the SF-36 Physical Composite | 4 months | The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Scores for the scale range from 0-100 and transformed to have a mean of 50 and SD of 10 in the reference population, with higher scores indicating a better Health-related Quality of Life. |
| Health-related Quality of Life Using the SF-36 Mental Composite | 4 months | The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Scores for the scale range from 0-100 and transformed to have a mean of 50 and SD of 10 in the reference population, with higher scores indicating a better Health-related Quality of Life. |
| Infection Rates | Up to 4 years | Infection (treated with intravenous or oral antibiotics) rates |
Countries
Australia, Canada, Czechia, Ireland, Italy, Japan, New Zealand, Sweden, United Kingdom, United States
Participant flow
Pre-assignment details
Of 188 enrolled participants, 170 met the criteria for randomisation and were randomised for treatment.
Participants by arm
| Arm | Count |
|---|---|
| Rituximab Maintenance Rituximab maintenance: 1g at 4, 8, 12, 16 & 20 months with standardised steroid taper
Rituximab: Rituximab IV infusion 1000 mg x 1 dose at months 4, 8, 12, 16 and 20 and glucocorticoids. Four - six hour infusion. Treatment with rituximab will cease at month 20. | 85 |
| Azathioprine Maintenance Azathioprine Maintenance: 2mg/kg/day with standardised steroid taper, from month 4 (randomisation) (200 mg maximum daily dose). Azathioprine withdrawn at month 27.
Azathioprine: Oral dosage form. Target dose is 2mg/kg; maximum daily dose is 200mg. This should be continued until month 24. The dose should then by reduced by 50% and azathioprine completely withdrawn at month 27.
The dose should be rounded down to the nearest 25mg. The dose may vary on alternate days e.g. 100mg one day, 150mg the next for patients on an overall dose of 125mg daily.
If patients are aged over 60 years, reduce the dose by 25%. If patients are aged over 75 years, reduce the dose by 50%. | 85 |
| Total | 170 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 1 |
| Overall Study | Death | 3 | 1 |
| Overall Study | Lost to Follow-up | 2 | 4 |
| Overall Study | Physician Decision | 2 | 4 |
| Overall Study | Withdrawal by Subject | 5 | 5 |
Baseline characteristics
| Characteristic | Rituximab Maintenance | Azathioprine Maintenance | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 31 Participants | 34 Participants | 65 Participants |
| Age, Categorical Between 18 and 65 years | 54 Participants | 51 Participants | 105 Participants |
| Age, Continuous | 57.1 years STANDARD_DEVIATION 15.1 | 58.6 years STANDARD_DEVIATION 13.9 | 57.8 years STANDARD_DEVIATION 14.5 |
| ANCA type anti-MPO | 24 Participants | 23 Participants | 47 Participants |
| ANCA type anti-PR3 | 61 Participants | 62 Participants | 123 Participants |
| Prednisone Induction Regimen 1A (starting dose 1mg/kg/day) | 24 Participants | 24 Participants | 48 Participants |
| Prednisone Induction Regimen 1B (starting dose 0.5mg/kg/day) | 61 Participants | 61 Participants | 122 Participants |
| Race/Ethnicity, Customized Asian | 5 Participants | 5 Participants | 10 Participants |
| Race/Ethnicity, Customized Black | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Hispanic | 2 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 78 Participants | 77 Participants | 155 Participants |
| Region of Enrollment Australia | 5 Participants | 5 Participants | 10 Participants |
| Region of Enrollment Canada | 13 Participants | 11 Participants | 24 Participants |
| Region of Enrollment Czechia | 0 Participants | 1 Participants | 1 Participants |
| Region of Enrollment Japan | 2 Participants | 2 Participants | 4 Participants |
| Region of Enrollment Sweden | 3 Participants | 2 Participants | 5 Participants |
| Region of Enrollment United Kingdom | 36 Participants | 42 Participants | 78 Participants |
| Region of Enrollment United States | 26 Participants | 22 Participants | 48 Participants |
| Relapse type Non-severe | 33 Participants | 31 Participants | 64 Participants |
| Relapse type Severe | 52 Participants | 54 Participants | 106 Participants |
| Sex: Female, Male Female | 42 Participants | 44 Participants | 86 Participants |
| Sex: Female, Male Male | 43 Participants | 41 Participants | 84 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 85 | 1 / 85 |
| other Total, other adverse events | 42 / 85 | 43 / 85 |
| serious Total, serious adverse events | 19 / 85 | 31 / 85 |
Outcome results
Primary
Relapse-free Survival
The primary efficacy outcome measure of the trial is relapse-free survival, where a relapse is either major or minor. The primary analysis will be a Cox regression model adjusted for the stratification factors (ANCA type, relapse severity and prednisone induction regimen) for the difference in the distribution of relapse-free survival between the rituximab arm and the azathioprine (control) arm (two-sided at α-level of 5%).
Time frame: Any patients who have not relapsed at up to a maximum of 4 years will be censored.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rituximab Maintenance | Relapse-free Survival | Total number of patients with a relapse | 38 participants |
| Rituximab Maintenance | Relapse-free Survival | Total number of patients with a relapse during treatment | 13 participants |
| Rituximab Maintenance | Relapse-free Survival | Total number of patients with a relapse post treatment | 25 participants |
| Azathioprine Maintenance | Relapse-free Survival | Total number of patients with a relapse | 60 participants |
| Azathioprine Maintenance | Relapse-free Survival | Total number of patients with a relapse during treatment | 32 participants |
| Azathioprine Maintenance | Relapse-free Survival | Total number of patients with a relapse post treatment | 28 participants |
Secondary
Combined Damage Assessment Score (Disease Related Damage Assessment)
Cumulative accrual of damage as measured by the combined damage assessment score (CDA). Each persistent or new occurrence of damage is given a score of 1. The cumulative accrual of damage is obtained by summing across the different types of damage to get an overall score (max score = 64).
Time frame: data in Rows represent the change from randomization (month 4) to months 12, 24, 36, and 48.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rituximab Maintenance | Combined Damage Assessment Score (Disease Related Damage Assessment) | Randomisation to month 12 | 0.275 score on a scale | Standard Deviation 0.656 |
| Rituximab Maintenance | Combined Damage Assessment Score (Disease Related Damage Assessment) | Randomisation to month 24 | 0.571 score on a scale | Standard Deviation 0.909 |
| Rituximab Maintenance | Combined Damage Assessment Score (Disease Related Damage Assessment) | Randomisation to month 36 | 0.676 score on a scale | Standard Deviation 0.995 |
| Rituximab Maintenance | Combined Damage Assessment Score (Disease Related Damage Assessment) | Randomisation to month 48 | 1.09 score on a scale | Standard Deviation 1.18 |
| Azathioprine Maintenance | Combined Damage Assessment Score (Disease Related Damage Assessment) | Randomisation to month 48 | 1.38 score on a scale | Standard Deviation 1.65 |
| Azathioprine Maintenance | Combined Damage Assessment Score (Disease Related Damage Assessment) | Randomisation to month 12 | 0.337 score on a scale | Standard Deviation 0.61 |
| Azathioprine Maintenance | Combined Damage Assessment Score (Disease Related Damage Assessment) | Randomisation to month 36 | 0.899 score on a scale | Standard Deviation 1.352 |
| Azathioprine Maintenance | Combined Damage Assessment Score (Disease Related Damage Assessment) | Randomisation to month 24 | 0.533 score on a scale | Standard Deviation 0.777 |
Secondary
Cumulative GC Exposure
Cumulative glucocorticoid (GC) exposure during the trial. The trial had a common close out date when the final patient reached month 36 in the trial. Patients were followed until month 48 or the common close out date, whichever happened sooner. Therefore, follow up varied between 36 and 48 months. Cumulative glucocorticoid exposure is presented as a dose in mg for during the treatment period (up to month 24) and across the whole trial (until month 48 or common close out when the final patient reached month 36).
Time frame: Up to 48 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rituximab Maintenance | Cumulative GC Exposure | Overall (randomisation to end of trial) | 3717 mg | Standard Deviation 3318 |
| Rituximab Maintenance | Cumulative GC Exposure | Maintenance treatment period (randomisation to month 24) | 2184 mg | Standard Deviation 1100 |
| Azathioprine Maintenance | Cumulative GC Exposure | Overall (randomisation to end of trial) | 4780 mg | Standard Deviation 3387 |
| Azathioprine Maintenance | Cumulative GC Exposure | Maintenance treatment period (randomisation to month 24) | 2426 mg | Standard Deviation 1324 |
Secondary
Health-related Quality of Life Using the SF-36 Mental Composite
The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Scores for the scale range from 0-100 and transformed to have a mean of 50 and SD of 10 in the reference population, with higher scores indicating a better Health-related Quality of Life.
Time frame: 36 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rituximab Maintenance | Health-related Quality of Life Using the SF-36 Mental Composite | 52.3 score on a scale | Standard Deviation 12.5 |
| Azathioprine Maintenance | Health-related Quality of Life Using the SF-36 Mental Composite | 51.8 score on a scale | Standard Deviation 10.8 |
Secondary
Health-related Quality of Life Using the SF-36 Mental Composite
The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Scores for the scale range from 0-100 and transformed to have a mean of 50 and SD of 10 in the reference population, with higher scores indicating a better Health-related Quality of Life.
Time frame: 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rituximab Maintenance | Health-related Quality of Life Using the SF-36 Mental Composite | 51.9 score on a scale | Standard Deviation 11.9 |
| Azathioprine Maintenance | Health-related Quality of Life Using the SF-36 Mental Composite | 53.5 score on a scale | Standard Deviation 10.7 |
Secondary
Health-related Quality of Life Using the SF-36 Mental Composite
The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Scores for the scale range from 0-100 and transformed to have a mean of 50 and SD of 10 in the reference population, with higher scores indicating a better Health-related Quality of Life.
Time frame: 4 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rituximab Maintenance | Health-related Quality of Life Using the SF-36 Mental Composite | 51.8 score on a scale | Standard Deviation 11.3 |
| Azathioprine Maintenance | Health-related Quality of Life Using the SF-36 Mental Composite | 51.0 score on a scale | Standard Deviation 11.4 |
Secondary
Health-related Quality of Life Using the SF-36 Mental Composite
The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Scores for the scale range from 0-100 and transformed to have a mean of 50 and SD of 10 in the reference population, with higher scores indicating a better Health-related Quality of Life.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rituximab Maintenance | Health-related Quality of Life Using the SF-36 Mental Composite | 50.8 score on a scale | Standard Deviation 12.4 |
| Azathioprine Maintenance | Health-related Quality of Life Using the SF-36 Mental Composite | 51.9 score on a scale | Standard Deviation 11.6 |
Secondary
Health-related Quality of Life Using the SF-36 Mental Composite
The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Scores for the scale range from 0-100 and transformed to have a mean of 50 and SD of 10 in the reference population, with higher scores indicating a better Health-related Quality of Life.
Time frame: 48 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rituximab Maintenance | Health-related Quality of Life Using the SF-36 Mental Composite | 50.9 score on a scale | Standard Deviation 13 |
| Azathioprine Maintenance | Health-related Quality of Life Using the SF-36 Mental Composite | 53.9 score on a scale | Standard Deviation 9.8 |
Secondary
Health-related Quality of Life Using the SF-36 Physical Composite
The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Scores for the scale range from 0-100 and transformed to have a mean of 50 and SD of 10 in the reference population, with higher scores indicating a better Health-related Quality of Life.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rituximab Maintenance | Health-related Quality of Life Using the SF-36 Physical Composite | 38.2 score on a scale | Standard Deviation 15.2 |
| Azathioprine Maintenance | Health-related Quality of Life Using the SF-36 Physical Composite | 34.6 score on a scale | Standard Deviation 15 |
Secondary
Health-related Quality of Life Using the SF-36 Physical Composite
The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Scores for the scale range from 0-100 and transformed to have a mean of 50 and SD of 10 in the reference population, with higher scores indicating a better Health-related Quality of Life.
Time frame: 4 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rituximab Maintenance | Health-related Quality of Life Using the SF-36 Physical Composite | 36.7 score on a scale | Standard Deviation 15.4 |
| Azathioprine Maintenance | Health-related Quality of Life Using the SF-36 Physical Composite | 36.1 score on a scale | Standard Deviation 14.1 |
Secondary
Health-related Quality of Life Using the SF-36 Physical Composite
The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Scores for the scale range from 0-100 and transformed to have a mean of 50 and SD of 10 in the reference population, with higher scores indicating a better Health-related Quality of Life.
Time frame: 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rituximab Maintenance | Health-related Quality of Life Using the SF-36 Physical Composite | 36.7 score on a scale | Standard Deviation 15.8 |
| Azathioprine Maintenance | Health-related Quality of Life Using the SF-36 Physical Composite | 35.6 score on a scale | Standard Deviation 14.5 |
Secondary
Health-related Quality of Life Using the SF-36 Physical Composite
The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Scores for the scale range from 0-100 and transformed to have a mean of 50 and SD of 10 in the reference population, with higher scores indicating a better Health-related Quality of Life.
Time frame: 36 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rituximab Maintenance | Health-related Quality of Life Using the SF-36 Physical Composite | 34.6 score on a scale | Standard Deviation 15.9 |
| Azathioprine Maintenance | Health-related Quality of Life Using the SF-36 Physical Composite | 33.8 score on a scale | Standard Deviation 15.6 |
Secondary
Health-related Quality of Life Using the SF-36 Physical Composite
The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Scores for the scale range from 0-100 and transformed to have a mean of 50 and SD of 10 in the reference population, with higher scores indicating a better Health-related Quality of Life.
Time frame: 48 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rituximab Maintenance | Health-related Quality of Life Using the SF-36 Physical Composite | 35.8 score on a scale | Standard Deviation 14.9 |
| Azathioprine Maintenance | Health-related Quality of Life Using the SF-36 Physical Composite | 35.0 score on a scale | Standard Deviation 16.3 |
Secondary
Infection Rates
Infection (treated with intravenous or oral antibiotics) rates
Time frame: Up to 4 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rituximab Maintenance | Infection Rates | 54 Participants |
| Azathioprine Maintenance | Infection Rates | 62 Participants |
Secondary
Number of Participants in Remission at 24 and 48 Months
Proportion of patients who maintain remission at 24 and 48 months
Time frame: 24 and 48 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Rituximab Maintenance | Number of Participants in Remission at 24 and 48 Months | Month 24 | 73 Participants |
| Rituximab Maintenance | Number of Participants in Remission at 24 and 48 Months | Month 48 | 54 Participants |
| Azathioprine Maintenance | Number of Participants in Remission at 24 and 48 Months | Month 24 | 70 Participants |
| Azathioprine Maintenance | Number of Participants in Remission at 24 and 48 Months | Month 48 | 44 Participants |
Secondary
Severe Adverse Event Rate
Severe adverse event (SAE) rate
Time frame: Up to 48 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rituximab Maintenance | Severe Adverse Event Rate | 37 Participants |
| Azathioprine Maintenance | Severe Adverse Event Rate | 48 Participants |