Trial Outcomes & Findings for Rituximab Vasculitis Maintenance Study (NCT NCT01697267)
NCT ID: NCT01697267
Last Updated: 2022-03-18
Results Overview
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%).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
188 participants
Primary outcome timeframe
Any patients who have not relapsed at up to a maximum of 4 years will be censored.
Results posted on
2022-03-18
Participant Flow
Of 188 enrolled participants, 170 met the criteria for randomisation and were randomised for treatment.
Participant milestones
| Measure |
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.
|
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 Azathioprine withdrawn at month 27.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 The dose should then by reduced by 50% and azathioprine completely withdrawn at month 27.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%.
|
|---|---|---|
|
Overall Study
STARTED
|
85
|
85
|
|
Overall Study
Month 24
|
78
|
78
|
|
Overall Study
COMPLETED
|
71
|
70
|
|
Overall Study
NOT COMPLETED
|
14
|
15
|
Reasons for withdrawal
| Measure |
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.
|
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%.
|
|---|---|---|
|
Overall Study
Death
|
3
|
1
|
|
Overall Study
Withdrawal by Subject
|
5
|
5
|
|
Overall Study
Adverse Event
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
4
|
|
Overall Study
Physician Decision
|
2
|
4
|
Baseline Characteristics
Rituximab Vasculitis Maintenance Study
Baseline characteristics by cohort
| Measure |
Rituximab Maintenance
n=85 Participants
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.
|
Azathioprine Maintenance
n=85 Participants
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%.
|
Total
n=170 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
54 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
31 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Age, Continuous
|
57.1 years
STANDARD_DEVIATION 15.1 • n=5 Participants
|
58.6 years
STANDARD_DEVIATION 13.9 • n=7 Participants
|
57.8 years
STANDARD_DEVIATION 14.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
78 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
155 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
26 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Region of Enrollment
Czechia
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
36 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
ANCA type
anti-PR3
|
61 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
123 Participants
n=5 Participants
|
|
ANCA type
anti-MPO
|
24 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Prednisone Induction Regimen
1A (starting dose 1mg/kg/day)
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Prednisone Induction Regimen
1B (starting dose 0.5mg/kg/day)
|
61 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
|
Relapse type
Severe
|
52 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
|
Relapse type
Non-severe
|
33 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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%).
Outcome measures
| Measure |
Rituximab Maintenance
n=85 Participants
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.
|
Azathioprine Maintenance
n=85 Participants
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%.
|
|---|---|---|
|
Relapse-free Survival
Total number of patients with a relapse during treatment
|
13 participants
|
32 participants
|
|
Relapse-free Survival
Total number of patients with a relapse
|
38 participants
|
60 participants
|
|
Relapse-free Survival
Total number of patients with a relapse post treatment
|
25 participants
|
28 participants
|
SECONDARY outcome
Timeframe: 24 and 48 monthsProportion of patients who maintain remission at 24 and 48 months
Outcome measures
| Measure |
Rituximab Maintenance
n=85 Participants
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.
|
Azathioprine Maintenance
n=85 Participants
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%.
|
|---|---|---|
|
Number of Participants in Remission at 24 and 48 Months
Month 24
|
73 Participants
|
70 Participants
|
|
Number of Participants in Remission at 24 and 48 Months
Month 48
|
54 Participants
|
44 Participants
|
SECONDARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Rituximab Maintenance
n=85 Participants
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.
|
Azathioprine Maintenance
n=85 Participants
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%.
|
|---|---|---|
|
Combined Damage Assessment Score (Disease Related Damage Assessment)
Randomisation to month 12
|
0.275 score on a scale
Standard Deviation 0.656
|
0.337 score on a scale
Standard Deviation 0.610
|
|
Combined Damage Assessment Score (Disease Related Damage Assessment)
Randomisation to month 24
|
0.571 score on a scale
Standard Deviation 0.909
|
0.533 score on a scale
Standard Deviation 0.777
|
|
Combined Damage Assessment Score (Disease Related Damage Assessment)
Randomisation to month 36
|
0.676 score on a scale
Standard Deviation 0.995
|
0.899 score on a scale
Standard Deviation 1.352
|
|
Combined Damage Assessment Score (Disease Related Damage Assessment)
Randomisation to month 48
|
1.09 score on a scale
Standard Deviation 1.18
|
1.38 score on a scale
Standard Deviation 1.65
|
SECONDARY outcome
Timeframe: Up to 48 monthsCumulative 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).
Outcome measures
| Measure |
Rituximab Maintenance
n=85 Participants
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.
|
Azathioprine Maintenance
n=85 Participants
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%.
|
|---|---|---|
|
Cumulative GC Exposure
Overall (randomisation to end of trial)
|
3717 mg
Standard Deviation 3318
|
4780 mg
Standard Deviation 3387
|
|
Cumulative GC Exposure
Maintenance treatment period (randomisation to month 24)
|
2184 mg
Standard Deviation 1100
|
2426 mg
Standard Deviation 1324
|
SECONDARY outcome
Timeframe: Up to 48 monthsSevere adverse event (SAE) rate
Outcome measures
| Measure |
Rituximab Maintenance
n=85 Participants
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.
|
Azathioprine Maintenance
n=85 Participants
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%.
|
|---|---|---|
|
Severe Adverse Event Rate
|
37 Participants
|
48 Participants
|
SECONDARY outcome
Timeframe: Up to 4 yearsInfection (treated with intravenous or oral antibiotics) rates
Outcome measures
| Measure |
Rituximab Maintenance
n=85 Participants
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.
|
Azathioprine Maintenance
n=85 Participants
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%.
|
|---|---|---|
|
Infection Rates
|
54 Participants
|
62 Participants
|
SECONDARY outcome
Timeframe: 4 monthsThe 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.
Outcome measures
| Measure |
Rituximab Maintenance
n=83 Participants
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.
|
Azathioprine Maintenance
n=81 Participants
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%.
|
|---|---|---|
|
Health-related Quality of Life Using the SF-36 Physical Composite
|
36.7 score on a scale
Standard Deviation 15.4
|
36.1 score on a scale
Standard Deviation 14.1
|
SECONDARY outcome
Timeframe: 4 monthsThe 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.
Outcome measures
| Measure |
Rituximab Maintenance
n=83 Participants
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.
|
Azathioprine Maintenance
n=81 Participants
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%.
|
|---|---|---|
|
Health-related Quality of Life Using the SF-36 Mental Composite
|
51.8 score on a scale
Standard Deviation 11.3
|
51.0 score on a scale
Standard Deviation 11.4
|
SECONDARY outcome
Timeframe: 12 monthsThe 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.
Outcome measures
| Measure |
Rituximab Maintenance
n=80 Participants
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.
|
Azathioprine Maintenance
n=80 Participants
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%.
|
|---|---|---|
|
Health-related Quality of Life Using the SF-36 Physical Composite
|
38.2 score on a scale
Standard Deviation 15.2
|
34.6 score on a scale
Standard Deviation 15.0
|
SECONDARY outcome
Timeframe: 12 monthsThe 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.
Outcome measures
| Measure |
Rituximab Maintenance
n=80 Participants
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.
|
Azathioprine Maintenance
n=80 Participants
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%.
|
|---|---|---|
|
Health-related Quality of Life Using the SF-36 Mental Composite
|
50.8 score on a scale
Standard Deviation 12.4
|
51.9 score on a scale
Standard Deviation 11.6
|
SECONDARY outcome
Timeframe: 24 monthsThe 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.
Outcome measures
| Measure |
Rituximab Maintenance
n=77 Participants
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.
|
Azathioprine Maintenance
n=70 Participants
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%.
|
|---|---|---|
|
Health-related Quality of Life Using the SF-36 Physical Composite
|
36.7 score on a scale
Standard Deviation 15.8
|
35.6 score on a scale
Standard Deviation 14.5
|
SECONDARY outcome
Timeframe: 24 monthsThe 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.
Outcome measures
| Measure |
Rituximab Maintenance
n=77 Participants
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.
|
Azathioprine Maintenance
n=70 Participants
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%.
|
|---|---|---|
|
Health-related Quality of Life Using the SF-36 Mental Composite
|
51.9 score on a scale
Standard Deviation 11.9
|
53.5 score on a scale
Standard Deviation 10.7
|
SECONDARY outcome
Timeframe: 36 monthsThe 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.
Outcome measures
| Measure |
Rituximab Maintenance
n=74 Participants
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.
|
Azathioprine Maintenance
n=69 Participants
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%.
|
|---|---|---|
|
Health-related Quality of Life Using the SF-36 Physical Composite
|
34.6 score on a scale
Standard Deviation 15.9
|
33.8 score on a scale
Standard Deviation 15.6
|
SECONDARY outcome
Timeframe: 36 monthsThe 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.
Outcome measures
| Measure |
Rituximab Maintenance
n=74 Participants
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.
|
Azathioprine Maintenance
n=69 Participants
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%.
|
|---|---|---|
|
Health-related Quality of Life Using the SF-36 Mental Composite
|
52.3 score on a scale
Standard Deviation 12.5
|
51.8 score on a scale
Standard Deviation 10.8
|
SECONDARY outcome
Timeframe: 48 monthsThe 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.
Outcome measures
| Measure |
Rituximab Maintenance
n=55 Participants
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.
|
Azathioprine Maintenance
n=51 Participants
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%.
|
|---|---|---|
|
Health-related Quality of Life Using the SF-36 Physical Composite
|
35.8 score on a scale
Standard Deviation 14.9
|
35.0 score on a scale
Standard Deviation 16.3
|
SECONDARY outcome
Timeframe: 48 monthsThe 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.
Outcome measures
| Measure |
Rituximab Maintenance
n=55 Participants
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.
|
Azathioprine Maintenance
n=51 Participants
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%.
|
|---|---|---|
|
Health-related Quality of Life Using the SF-36 Mental Composite
|
50.9 score on a scale
Standard Deviation 13.0
|
53.9 score on a scale
Standard Deviation 9.8
|
Adverse Events
Rituximab Maintenance
Serious events: 19 serious events
Other events: 42 other events
Deaths: 3 deaths
Azathioprine Maintenance
Serious events: 31 serious events
Other events: 43 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Rituximab Maintenance
n=85 participants at risk
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.
|
Azathioprine Maintenance
n=85 participants at risk
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%.
|
|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Cardiac disorders
Atrioventricular block complete
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Cardiac disorders
Cardiac failure congestive
|
2.4%
2/85 • Number of events 2 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Eye disorders
Periorbital oedema
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.4%
2/85 • Number of events 2 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Gastrointestinal disorders
Oesophageal spasm
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Gastrointestinal disorders
Pancreatitis
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Gastrointestinal disorders
Enterovesical fistula
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
General disorders
Chest pain
|
2.4%
2/85 • Number of events 2 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
General disorders
Pyrexia
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
General disorders
Perforated ulcer
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
General disorders
Stenosis
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Hepatobiliary disorders
Cholecystitis
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
2.4%
2/85 • Number of events 2 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Immune system disorders
Pulmonary vasculitis
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Immune system disorders
Vasculitis
|
4.7%
4/85 • Number of events 13 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
10.6%
9/85 • Number of events 13 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Appendicitis
|
2.4%
2/85 • Number of events 2 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Bronchitis
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
2.4%
2/85 • Number of events 2 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Dacryocystitis
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Influenza
|
2.4%
2/85 • Number of events 2 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
3.5%
3/85 • Number of events 3 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
2.4%
2/85 • Number of events 2 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Pneumonia
|
5.9%
5/85 • Number of events 5 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
3.5%
3/85 • Number of events 3 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Pneumonia klebsiella
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Pneumonia viral
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Sepsis
|
2.4%
2/85 • Number of events 2 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Sinusitis
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Urinary tract infection
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
2.4%
2/85 • Number of events 2 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Escherichia urinary tract infection
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Periorbital abscess
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Respiratory tract infection
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
3.5%
3/85 • Number of events 3 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Metapneumovirus infection
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Injury, poisoning and procedural complications
Accident
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Injury, poisoning and procedural complications
Intra-abdominal haemorrhage
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Investigations
Medical observation
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Investigations
Transaminases increased
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Musculoskeletal and connective tissue disorders
Myasthenia gravis
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Musculoskeletal and connective tissue disorders
Myasthenia gravis crisis
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Musculoskeletal and connective tissue disorders
Pubis fracture
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder papilloma
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sarcoma of skin
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon neoplasm 1
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal squamous cell carcinoma
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Nervous system disorders
Sleep apnoea syndrome
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Nervous system disorders
Subdural haemorrhage
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Psychiatric disorders
Conversion disorder
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Renal and urinary disorders
Nephrolithiasis
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Renal and urinary disorders
Proteinuria
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Renal and urinary disorders
Renal impairment
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
4.7%
4/85 • Number of events 4 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
2.4%
2/85 • Number of events 2 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal stenosis
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Surgical and medical procedures
Aortic valve replacement
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Surgical and medical procedures
Bunion operation
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Surgical and medical procedures
Cholecystectomy
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Surgical and medical procedures
Colostomy closure
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Surgical and medical procedures
Dacryocystorhinostomy
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Surgical and medical procedures
Hip arthroplasty
|
2.4%
2/85 • Number of events 2 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
3.5%
3/85 • Number of events 3 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Surgical and medical procedures
Knee arthroplasty
|
2.4%
2/85 • Number of events 2 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Surgical and medical procedures
Lung lobectomy
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Surgical and medical procedures
Renal transplant
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Surgical and medical procedures
Spinal decompression
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Surgical and medical procedures
Renal and pancreas transplant
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Surgical and medical procedures
Sigmoidectomy
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Surgical and medical procedures
Cardiac ablation
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Surgical and medical procedures
Infusion
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Surgical and medical procedures
Colporrhaphy
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Surgical and medical procedures
Thyroidectomy
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Surgical and medical procedures
Joint resurfacing surgery
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Surgical and medical procedures
Vascular anastomosis
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Vascular disorders
Epistaxis
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
2.4%
2/85 • Number of events 2 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Vascular disorders
Haemoptysis
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Vascular disorders
Orthostatic hypotension
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Vascular disorders
Pulmonary embolism
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Vascular disorders
Vascular injury
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Vascular disorders
Vascular pseudoaneurysm
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
Other adverse events
| Measure |
Rituximab Maintenance
n=85 participants at risk
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.
|
Azathioprine Maintenance
n=85 participants at risk
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%.
|
|---|---|---|
|
General disorders
Malaise
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Hepatobiliary disorders
Cholecystitis
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Bacterial dacryocystitis
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Bacterial infection
|
2.4%
2/85 • Number of events 2 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Beta haemolytic streptococcal infection
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Bronchitis haemophilus
|
2.4%
2/85 • Number of events 2 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Cellulitis
|
3.5%
3/85 • Number of events 3 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
5.9%
5/85 • Number of events 5 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Cellulitis orbital
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Citrobacter infection
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Cystitis escherichia
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
2.4%
2/85 • Number of events 2 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Cystitis klebsiella
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Enterococcal infection
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Escherichia urinary tract infection
|
3.5%
3/85 • Number of events 3 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
2.4%
2/85 • Number of events 2 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Haemophilus infection
|
2.4%
2/85 • Number of events 2 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
4.7%
4/85 • Number of events 4 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Klebsiella infection
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Pneumonia haemophilus
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Pneumonia klebsiella
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Pneumonia pneumococca
|
2.4%
2/85 • Number of events 2 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Pneumonia pseudomonal
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Proteus infection
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Pseudomonas bronchitis
|
2.4%
2/85 • Number of events 2 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Pseudomonas infection
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Staphylococcal impetigo
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Staphylococcal infection
|
3.5%
3/85 • Number of events 3 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
2.4%
2/85 • Number of events 2 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Tonsillitis bacterial
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Urinary tract infection enterococcal
|
2.4%
2/85 • Number of events 2 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Body tinea
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Candida infection
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Oral candidiasis
|
2.4%
2/85 • Number of events 2 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Tinea infection
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
2.4%
2/85 • Number of events 2 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
2.4%
2/85 • Number of events 2 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Bronchitis
|
2.4%
2/85 • Number of events 2 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Conjunctivitis
|
2.4%
2/85 • Number of events 2 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
2.4%
2/85 • Number of events 2 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Cystitis
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Ear infection
|
5.9%
5/85 • Number of events 5 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
4.7%
4/85 • Number of events 4 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Eye infection
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
2.4%
2/85 • Number of events 2 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Infection
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
2.4%
2/85 • Number of events 2 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Lower respiratory tract infection
|
2.4%
2/85 • Number of events 2 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
8.2%
7/85 • Number of events 7 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Lung infection
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Mastoiditis
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Otitis media
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Paronychia
|
2.4%
2/85 • Number of events 2 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Pharyngitis
|
2.4%
2/85 • Number of events 2 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
2.4%
2/85 • Number of events 2 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Pneumonia
|
3.5%
3/85 • Number of events 3 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Prostate infection
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Respiratory tract infection
|
22.4%
19/85 • Number of events 19 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
36.5%
31/85 • Number of events 31 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Root canal infection
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Sinusitis
|
17.6%
15/85 • Number of events 15 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
11.8%
10/85 • Number of events 10 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Skin infection
|
5.9%
5/85 • Number of events 5 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
4.7%
4/85 • Number of events 4 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Systemic infection
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Tonsillitis
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Tooth abscess
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
2.4%
2/85 • Number of events 2 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Tooth infection
|
3.5%
3/85 • Number of events 3 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Upper respiratory tract infection
|
20.0%
17/85 • Number of events 17 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
20.0%
17/85 • Number of events 17 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Urinary tract infection
|
10.6%
9/85 • Number of events 9 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
8.2%
7/85 • Number of events 7 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Herpes zoster
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
2.4%
2/85 • Number of events 2 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Respiratory tract infection viral
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Varicella zoster virus infection
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Infections and infestations
Viral infection
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Investigations
Streptococcus test positive
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.00%
0/85 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
|
Additional Information
Prof David Jayne
Cambridge University Hospitals NHS Foundation Trust
Phone: 01223 748062
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place