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Rituximab Vasculitis Maintenance Study (RITAZAREM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01697267
Recruitment Status : Completed
First Posted : October 2, 2012
Results First Posted : March 18, 2022
Last Update Posted : March 18, 2022
Sponsor:
Collaborators:
Arthritis Research UK
Roche Pharma AG
Genentech, Inc.
University of Pennsylvania
Information provided by (Responsible Party):
David Jayne, Cambridge University Hospitals NHS Foundation Trust

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Microscopic Polyangiitis
Wegener Granulomatosis
Interventions Biological: Rituximab
Drug: Azathioprine
Enrollment 188
Recruitment Details  
Pre-assignment Details Of 188 enrolled participants, 170 met the criteria for randomisation and were randomised for treatment.
Arm/Group Title Rituximab Maintenance Azathioprine Maintenance
Hide Arm/Group Description

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: 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 Azathioprine withdrawn at month 27.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 The dose should then by reduced by 50% and azathioprine completely withdrawn at month 27.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%.

Period Title: Overall Study
Started 85 85
Month 24 78 78
Completed 71 70
Not Completed 14 15
Reason Not Completed
Death             3             1
Withdrawal by Subject             5             5
Adverse Event             2             1
Lost to Follow-up             2             4
Physician Decision             2             4
Arm/Group Title Rituximab Maintenance Azathioprine Maintenance Total
Hide Arm/Group Description

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: 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 of all reporting groups
Overall Number of Baseline Participants 85 85 170
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 85 participants 85 participants 170 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
54
  63.5%
51
  60.0%
105
  61.8%
>=65 years
31
  36.5%
34
  40.0%
65
  38.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 85 participants 85 participants 170 participants
57.1  (15.1) 58.6  (13.9) 57.8  (14.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 85 participants 85 participants 170 participants
Female
42
  49.4%
44
  51.8%
86
  50.6%
Male
43
  50.6%
41
  48.2%
84
  49.4%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 85 participants 85 participants 170 participants
White
78
  91.8%
77
  90.6%
155
  91.2%
Black
0
   0.0%
0
   0.0%
0
   0.0%
Asian
5
   5.9%
5
   5.9%
10
   5.9%
Hispanic
2
   2.4%
1
   1.2%
3
   1.8%
Other
0
   0.0%
2
   2.4%
2
   1.2%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 85 participants 85 participants 170 participants
Canada
13
  15.3%
11
  12.9%
24
  14.1%
Sweden
3
   3.5%
2
   2.4%
5
   2.9%
United States
26
  30.6%
22
  25.9%
48
  28.2%
Czechia
0
   0.0%
1
   1.2%
1
   0.6%
Japan
2
   2.4%
2
   2.4%
4
   2.4%
United Kingdom
36
  42.4%
42
  49.4%
78
  45.9%
Australia
5
   5.9%
5
   5.9%
10
   5.9%
ANCA type   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 85 participants 85 participants 170 participants
anti-PR3
61
  71.8%
62
  72.9%
123
  72.4%
anti-MPO
24
  28.2%
23
  27.1%
47
  27.6%
[1]
Measure Description: Anti-neutrophil cytoplasm antibodies (ANCA) are autoantibodies that target a type of human white blood cell called neutrophils, which are important in health for fighting infection partly through the release of toxic substances that destroy bacteria. In ANCA-associated vasculitis, ANCA specifically bind to two proteins that are normally found in the fluid within the neutrophil (cytoplasm). The two proteins are called proteinase 3 (PR3) and myeloperoxidase (MPO) which can be measured by ELISA (Enzyme-Linked Immunosorbant Assay).
Prednisone Induction Regimen   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 85 participants 85 participants 170 participants
1A (starting dose 1mg/kg/day)
24
  28.2%
24
  28.2%
48
  28.2%
1B (starting dose 0.5mg/kg/day)
61
  71.8%
61
  71.8%
122
  71.8%
[1]
Measure Description:

Patients will be stratified at the time of randomisation according to selected prednisone induction regimen: 1A higher dose induction regimen or

1B lower dose induction regimen to take into consideration variability in disease severity and local GC prescribing.

Relapse type   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 85 participants 85 participants 170 participants
Severe
52
  61.2%
54
  63.5%
106
  62.4%
Non-severe
33
  38.8%
31
  36.5%
64
  37.6%
[1]
Measure Description: Major relapse (severe): The development of a new or recurrent major disease activity item using the BVAS/WG assessment tool Minor relapse (non-severe): Any increase in disease activity that does not meet the definition of Major Relapse
1.Primary Outcome
Title Relapse-free Survival
Hide Description The primary efficacy outcome measure of the trial is relapse-free survival, where a relapse is either major or minor. The primary analysis will be a Cox regression model adjusted for the stratification factors (ANCA type, relapse severity and prednisone induction regimen) for the difference in the distribution of relapse-free survival between the rituximab arm and the azathioprine (control) arm (two-sided at α-level of 5%).
Time Frame Any patients who have not relapsed at up to a maximum of 4 years will be censored.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rituximab Maintenance Azathioprine Maintenance
Hide Arm/Group Description:

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: 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 Number of Participants Analyzed 85 85
Measure Type: Number
Unit of Measure: participants
Total number of patients with a relapse 38 60
Total number of patients with a relapse during treatment 13 32
Total number of patients with a relapse post treatment 25 28
2.Secondary Outcome
Title Number of Participants in Remission at 24 and 48 Months
Hide Description Proportion of patients who maintain remission at 24 and 48 months
Time Frame 24 and 48 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rituximab Maintenance Azathioprine Maintenance
Hide Arm/Group Description:

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: 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 Number of Participants Analyzed 85 85
Measure Type: Count of Participants
Unit of Measure: Participants
Month 24
73
  85.9%
70
  82.4%
Month 48
54
  63.5%
44
  51.8%
3.Secondary Outcome
Title Combined Damage Assessment Score (Disease Related Damage Assessment)
Hide Description Cumulative accrual of damage as measured by the combined damage assessment score (CDA). Each persistent or new occurrence of damage is given a score of 1. The cumulative accrual of damage is obtained by summing across the different types of damage to get an overall score (max score = 64).
Time Frame data in Rows represent the change from randomization (month 4) to months 12, 24, 36, and 48.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rituximab Maintenance Azathioprine Maintenance
Hide Arm/Group Description:

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: 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 Number of Participants Analyzed 85 85
Mean (Standard Deviation)
Unit of Measure: score on a scale
Randomisation to month 12 0.275  (0.656) 0.337  (0.610)
Randomisation to month 24 0.571  (0.909) 0.533  (0.777)
Randomisation to month 36 0.676  (0.995) 0.899  (1.352)
Randomisation to month 48 1.09  (1.18) 1.38  (1.65)
4.Secondary Outcome
Title Cumulative GC Exposure
Hide Description Cumulative glucocorticoid (GC) exposure during the trial. The trial had a common close out date when the final patient reached month 36 in the trial. Patients were followed until month 48 or the common close out date, whichever happened sooner. Therefore, follow up varied between 36 and 48 months. Cumulative glucocorticoid exposure is presented as a dose in mg for during the treatment period (up to month 24) and across the whole trial (until month 48 or common close out when the final patient reached month 36).
Time Frame Up to 48 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rituximab Maintenance Azathioprine Maintenance
Hide Arm/Group Description:

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: 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 Number of Participants Analyzed 85 85
Mean (Standard Deviation)
Unit of Measure: mg
Overall (randomisation to end of trial) 3717  (3318) 4780  (3387)
Maintenance treatment period (randomisation to month 24) 2184  (1100) 2426  (1324)
5.Secondary Outcome
Title Severe Adverse Event Rate
Hide Description Severe adverse event (SAE) rate
Time Frame Up to 48 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rituximab Maintenance Azathioprine Maintenance
Hide Arm/Group Description:

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: 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 Number of Participants Analyzed 85 85
Measure Type: Count of Participants
Unit of Measure: Participants
37
  43.5%
48
  56.5%
6.Secondary Outcome
Title Infection Rates
Hide Description Infection (treated with intravenous or oral antibiotics) rates
Time Frame Up to 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rituximab Maintenance Azathioprine Maintenance
Hide Arm/Group Description:

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: 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 Number of Participants Analyzed 85 85
Measure Type: Count of Participants
Unit of Measure: Participants
54
  63.5%
62
  72.9%
7.Secondary Outcome
Title Health-related Quality of Life Using the SF-36 Physical Composite
Hide Description The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Scores for the scale range from 0-100 and transformed to have a mean of 50 and SD of 10 in the reference population, with higher scores indicating a better Health-related Quality of Life.
Time Frame 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rituximab Maintenance Azathioprine Maintenance
Hide Arm/Group Description:

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: 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 Number of Participants Analyzed 83 81
Mean (Standard Deviation)
Unit of Measure: score on a scale
36.7  (15.4) 36.1  (14.1)
8.Secondary Outcome
Title Health-related Quality of Life Using the SF-36 Mental Composite
Hide Description The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Scores for the scale range from 0-100 and transformed to have a mean of 50 and SD of 10 in the reference population, with higher scores indicating a better Health-related Quality of Life.
Time Frame 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rituximab Maintenance Azathioprine Maintenance
Hide Arm/Group Description:

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: 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 Number of Participants Analyzed 83 81
Mean (Standard Deviation)
Unit of Measure: score on a scale
51.8  (11.3) 51.0  (11.4)
9.Secondary Outcome
Title Health-related Quality of Life Using the SF-36 Physical Composite
Hide Description The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Scores for the scale range from 0-100 and transformed to have a mean of 50 and SD of 10 in the reference population, with higher scores indicating a better Health-related Quality of Life.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rituximab Maintenance Azathioprine Maintenance
Hide Arm/Group Description:

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: 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 Number of Participants Analyzed 80 80
Mean (Standard Deviation)
Unit of Measure: score on a scale
38.2  (15.2) 34.6  (15.0)
10.Secondary Outcome
Title Health-related Quality of Life Using the SF-36 Mental Composite
Hide Description The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Scores for the scale range from 0-100 and transformed to have a mean of 50 and SD of 10 in the reference population, with higher scores indicating a better Health-related Quality of Life.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rituximab Maintenance Azathioprine Maintenance
Hide Arm/Group Description:

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: 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 Number of Participants Analyzed 80 80
Mean (Standard Deviation)
Unit of Measure: score on a scale
50.8  (12.4) 51.9  (11.6)
11.Secondary Outcome
Title Health-related Quality of Life Using the SF-36 Physical Composite
Hide Description The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Scores for the scale range from 0-100 and transformed to have a mean of 50 and SD of 10 in the reference population, with higher scores indicating a better Health-related Quality of Life.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rituximab Maintenance Azathioprine Maintenance
Hide Arm/Group Description:

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: 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 Number of Participants Analyzed 77 70
Mean (Standard Deviation)
Unit of Measure: score on a scale
36.7  (15.8) 35.6  (14.5)
12.Secondary Outcome
Title Health-related Quality of Life Using the SF-36 Mental Composite
Hide Description The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Scores for the scale range from 0-100 and transformed to have a mean of 50 and SD of 10 in the reference population, with higher scores indicating a better Health-related Quality of Life.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rituximab Maintenance Azathioprine Maintenance
Hide Arm/Group Description:

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: 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 Number of Participants Analyzed 77 70
Mean (Standard Deviation)
Unit of Measure: score on a scale
51.9  (11.9) 53.5  (10.7)
13.Secondary Outcome
Title Health-related Quality of Life Using the SF-36 Physical Composite
Hide Description The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Scores for the scale range from 0-100 and transformed to have a mean of 50 and SD of 10 in the reference population, with higher scores indicating a better Health-related Quality of Life.
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rituximab Maintenance Azathioprine Maintenance
Hide Arm/Group Description:

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: 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 Number of Participants Analyzed 74 69
Mean (Standard Deviation)
Unit of Measure: score on a scale
34.6  (15.9) 33.8  (15.6)
14.Secondary Outcome
Title Health-related Quality of Life Using the SF-36 Mental Composite
Hide Description The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Scores for the scale range from 0-100 and transformed to have a mean of 50 and SD of 10 in the reference population, with higher scores indicating a better Health-related Quality of Life.
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rituximab Maintenance Azathioprine Maintenance
Hide Arm/Group Description:

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: 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 Number of Participants Analyzed 74 69
Mean (Standard Deviation)
Unit of Measure: score on a scale
52.3  (12.5) 51.8  (10.8)
15.Secondary Outcome
Title Health-related Quality of Life Using the SF-36 Physical Composite
Hide Description The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Scores for the scale range from 0-100 and transformed to have a mean of 50 and SD of 10 in the reference population, with higher scores indicating a better Health-related Quality of Life.
Time Frame 48 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rituximab Maintenance Azathioprine Maintenance
Hide Arm/Group Description:

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: 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 Number of Participants Analyzed 55 51
Mean (Standard Deviation)
Unit of Measure: score on a scale
35.8  (14.9) 35.0  (16.3)
16.Secondary Outcome
Title Health-related Quality of Life Using the SF-36 Mental Composite
Hide Description The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Scores for the scale range from 0-100 and transformed to have a mean of 50 and SD of 10 in the reference population, with higher scores indicating a better Health-related Quality of Life.
Time Frame 48 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rituximab Maintenance Azathioprine Maintenance
Hide Arm/Group Description:

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: 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 Number of Participants Analyzed 55 51
Mean (Standard Deviation)
Unit of Measure: score on a scale
50.9  (13.0) 53.9  (9.8)
Time Frame Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Rituximab Maintenance Azathioprine Maintenance
Hide Arm/Group Description

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: 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%.

All-Cause Mortality
Rituximab Maintenance Azathioprine Maintenance
Affected / at Risk (%) Affected / at Risk (%)
Total   3/85 (3.53%)      1/85 (1.18%)    
Hide Serious Adverse Events
Rituximab Maintenance Azathioprine Maintenance
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   19/85 (22.35%)      31/85 (36.47%)    
Blood and lymphatic system disorders     
Iron deficiency anaemia  1  1/85 (1.18%)  1 0/85 (0.00%)  0
Neutropenia  1  0/85 (0.00%)  0 1/85 (1.18%)  1
Cardiac disorders     
Atrial fibrillation  1  0/85 (0.00%)  0 1/85 (1.18%)  1
Atrioventricular block complete  1  1/85 (1.18%)  1 0/85 (0.00%)  0
Cardiac failure congestive  1  2/85 (2.35%)  2 0/85 (0.00%)  0
Cardiomyopathy  1  0/85 (0.00%)  0 1/85 (1.18%)  1
Coronary artery disease  1  0/85 (0.00%)  0 1/85 (1.18%)  1
Myocardial infarction  1  0/85 (0.00%)  0 1/85 (1.18%)  1
Eye disorders     
Periorbital oedema  1  1/85 (1.18%)  1 0/85 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain  1  2/85 (2.35%)  2 0/85 (0.00%)  0
Oesophageal spasm  1  1/85 (1.18%)  1 0/85 (0.00%)  0
Oesophagitis  1  0/85 (0.00%)  0 1/85 (1.18%)  1
Pancreatitis  1  1/85 (1.18%)  1 0/85 (0.00%)  0
Small intestinal obstruction  1  1/85 (1.18%)  1 0/85 (0.00%)  0
Enterovesical fistula  1  1/85 (1.18%)  1 0/85 (0.00%)  0
General disorders     
Chest pain  1  2/85 (2.35%)  2 0/85 (0.00%)  0
Pyrexia  1  1/85 (1.18%)  1 0/85 (0.00%)  0
Perforated ulcer  1  1/85 (1.18%)  1 0/85 (0.00%)  0
Stenosis  1  1/85 (1.18%)  1 0/85 (0.00%)  0
Hepatobiliary disorders     
Cholecystitis  1  1/85 (1.18%)  1 0/85 (0.00%)  0
Cholecystitis acute  1  1/85 (1.18%)  1 1/85 (1.18%)  1
Cholelithiasis  1  1/85 (1.18%)  1 0/85 (0.00%)  0
Immune system disorders     
Drug hypersensitivity  1  0/85 (0.00%)  0 2/85 (2.35%)  2
Pulmonary vasculitis  1  0/85 (0.00%)  0 1/85 (1.18%)  1
Vasculitis  1  4/85 (4.71%)  13 9/85 (10.59%)  13
Infections and infestations     
Appendicitis  1  2/85 (2.35%)  2 1/85 (1.18%)  1
Bronchitis  1  1/85 (1.18%)  1 2/85 (2.35%)  2
Cellulitis  1  0/85 (0.00%)  0 1/85 (1.18%)  1
Dacryocystitis  1  0/85 (0.00%)  0 1/85 (1.18%)  1
Diverticulitis  1  0/85 (0.00%)  0 1/85 (1.18%)  1
Gastroenteritis viral  1  0/85 (0.00%)  0 1/85 (1.18%)  1
Influenza  1  2/85 (2.35%)  2 3/85 (3.53%)  3
Lower respiratory tract infection  1  0/85 (0.00%)  0 2/85 (2.35%)  2
Peritonitis  1  0/85 (0.00%)  0 1/85 (1.18%)  1
Pneumonia  1  5/85 (5.88%)  5 3/85 (3.53%)  3
Pneumonia klebsiella  1  0/85 (0.00%)  0 1/85 (1.18%)  1
Pneumonia viral  1  1/85 (1.18%)  1 0/85 (0.00%)  0
Sepsis  1  2/85 (2.35%)  2 0/85 (0.00%)  0
Sinusitis  1  1/85 (1.18%)  1 0/85 (0.00%)  0
Urinary tract infection  1  1/85 (1.18%)  1 2/85 (2.35%)  2
Escherichia urinary tract infection  1  1/85 (1.18%)  1 0/85 (0.00%)  0
Periorbital abscess  1  1/85 (1.18%)  1 0/85 (0.00%)  0
Infective exacerbation of chronic obstructive airways disease  1  0/85 (0.00%)  0 1/85 (1.18%)  1
Respiratory tract infection  1  1/85 (1.18%)  1 3/85 (3.53%)  3
Metapneumovirus infection  1  1/85 (1.18%)  1 0/85 (0.00%)  0
Oral herpes  1  0/85 (0.00%)  0 1/85 (1.18%)  1
Injury, poisoning and procedural complications     
Accident  1  1/85 (1.18%)  1 0/85 (0.00%)  0
Fall  1  0/85 (0.00%)  0 1/85 (1.18%)  1
Subdural haematoma  1  0/85 (0.00%)  0 1/85 (1.18%)  1
Post procedural complication  1  0/85 (0.00%)  0 1/85 (1.18%)  1
Intra-abdominal haemorrhage  1  0/85 (0.00%)  0 1/85 (1.18%)  1
Vascular access complication  1  0/85 (0.00%)  0 1/85 (1.18%)  1
Investigations     
Medical observation  1  0/85 (0.00%)  0 1/85 (1.18%)  1
Transaminases increased  1  0/85 (0.00%)  0 1/85 (1.18%)  1
Metabolism and nutrition disorders     
Dehydration  1  0/85 (0.00%)  0 1/85 (1.18%)  1
Hyperglycaemia  1  0/85 (0.00%)  0 1/85 (1.18%)  1
Hyperkalaemia  1  0/85 (0.00%)  0 1/85 (1.18%)  1
Metabolic acidosis  1  0/85 (0.00%)  0 1/85 (1.18%)  1
Musculoskeletal and connective tissue disorders     
Myasthenia gravis  1  0/85 (0.00%)  0 1/85 (1.18%)  1
Osteoarthritis  1  1/85 (1.18%)  1 0/85 (0.00%)  0
Intervertebral disc protrusion  1  1/85 (1.18%)  1 0/85 (0.00%)  0
Myasthenia gravis crisis  1  0/85 (0.00%)  0 1/85 (1.18%)  1
Pubis fracture  1  0/85 (0.00%)  0 1/85 (1.18%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bladder papilloma  1  1/85 (1.18%)  1 0/85 (0.00%)  0
Lung adenocarcinoma  1  1/85 (1.18%)  1 0/85 (0.00%)  0
Pancreatic carcinoma metastatic  1  1/85 (1.18%)  1 1/85 (1.18%)  1
Sarcoma of skin  1  0/85 (0.00%)  0 1/85 (1.18%)  1
Squamous cell carcinoma  1  1/85 (1.18%)  1 1/85 (1.18%)  1
Colon neoplasm 1  1  0/85 (0.00%)  0 1/85 (1.18%)  1
Anal squamous cell carcinoma  1  0/85 (0.00%)  0 1/85 (1.18%)  1
Nervous system disorders     
Haemorrhagic stroke  1  0/85 (0.00%)  0 1/85 (1.18%)  1
Sleep apnoea syndrome  1  1/85 (1.18%)  1 0/85 (0.00%)  0
Subdural haemorrhage  1  0/85 (0.00%)  0 1/85 (1.18%)  1
Psychiatric disorders     
Conversion disorder  1  0/85 (0.00%)  0 1/85 (1.18%)  1
Renal and urinary disorders     
Nephrolithiasis  1  1/85 (1.18%)  1 0/85 (0.00%)  0
Proteinuria  1  1/85 (1.18%)  1 0/85 (0.00%)  0
Renal impairment  1  1/85 (1.18%)  1 0/85 (0.00%)  0
Acute kidney injury  1  0/85 (0.00%)  0 4/85 (4.71%)  4
Respiratory, thoracic and mediastinal disorders     
Bronchospasm  1  1/85 (1.18%)  1 0/85 (0.00%)  0
Chronic obstructive pulmonary disease  1  0/85 (0.00%)  0 1/85 (1.18%)  1
Dyspnoea  1  0/85 (0.00%)  0 2/85 (2.35%)  2
Laryngeal stenosis  1  0/85 (0.00%)  0 1/85 (1.18%)  1
Pneumonitis  1  0/85 (0.00%)  0 1/85 (1.18%)  1
Pneumothorax  1  0/85 (0.00%)  0 1/85 (1.18%)  1
Stridor  1  0/85 (0.00%)  0 1/85 (1.18%)  1
Pneumomediastinum  1  0/85 (0.00%)  0 1/85 (1.18%)  1
Surgical and medical procedures     
Aortic valve replacement  1  1/85 (1.18%)  1 0/85 (0.00%)  0
Bunion operation  1  0/85 (0.00%)  0 1/85 (1.18%)  1
Cholecystectomy  1  1/85 (1.18%)  1 1/85 (1.18%)  1
Colostomy closure  1  0/85 (0.00%)  0 1/85 (1.18%)  1
Dacryocystorhinostomy  1  0/85 (0.00%)  0 1/85 (1.18%)  1
Hip arthroplasty  1  2/85 (2.35%)  2 3/85 (3.53%)  3
Knee arthroplasty  1  2/85 (2.35%)  2 1/85 (1.18%)  1
Lung lobectomy  1  1/85 (1.18%)  1 0/85 (0.00%)  0
Renal transplant  1  1/85 (1.18%)  1 0/85 (0.00%)  0
Spinal decompression  1  0/85 (0.00%)  0 1/85 (1.18%)  1
Renal and pancreas transplant  1  1/85 (1.18%)  1 0/85 (0.00%)  0
Sigmoidectomy  1  0/85 (0.00%)  0 1/85 (1.18%)  1
Cardiac ablation  1  0/85 (0.00%)  0 1/85 (1.18%)  1
Infusion  1  0/85 (0.00%)  0 1/85 (1.18%)  1
Colporrhaphy  1  1/85 (1.18%)  1 0/85 (0.00%)  0
Thyroidectomy  1  0/85 (0.00%)  0 1/85 (1.18%)  1
Joint resurfacing surgery  1  0/85 (0.00%)  0 1/85 (1.18%)  1
Vascular anastomosis  1  0/85 (0.00%)  0 1/85 (1.18%)  1
Vascular disorders     
Epistaxis  1  0/85 (0.00%)  0 2/85 (2.35%)  2
Haemoptysis  1  1/85 (1.18%)  1 0/85 (0.00%)  0
Orthostatic hypotension  1  1/85 (1.18%)  1 0/85 (0.00%)  0
Pulmonary embolism  1  0/85 (0.00%)  0 1/85 (1.18%)  1
Vascular injury  1  1/85 (1.18%)  1 0/85 (0.00%)  0
Vascular pseudoaneurysm  1  0/85 (0.00%)  0 1/85 (1.18%)  1
Haemorrhage  1  0/85 (0.00%)  0 1/85 (1.18%)  1
1
Term from vocabulary, MedDRA (19.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Rituximab Maintenance Azathioprine Maintenance
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   42/85 (49.41%)      43/85 (50.59%)    
General disorders     
Malaise  1  0/85 (0.00%)  0 1/85 (1.18%)  1
Hepatobiliary disorders     
Cholecystitis  1  1/85 (1.18%)  1 0/85 (0.00%)  0
Infections and infestations     
Bacterial dacryocystitis  1  0/85 (0.00%)  0 1/85 (1.18%)  1
Bacterial infection  1  2/85 (2.35%)  2 0/85 (0.00%)  0
Beta haemolytic streptococcal infection  1  0/85 (0.00%)  0 1/85 (1.18%)  1
Bronchitis haemophilus  1  2/85 (2.35%)  2 0/85 (0.00%)  0
Cellulitis  1  3/85 (3.53%)  3 5/85 (5.88%)  5
Cellulitis orbital  1  0/85 (0.00%)  0 1/85 (1.18%)  1
Citrobacter infection  1  1/85 (1.18%)  1 1/85 (1.18%)  1
Cystitis escherichia  1  1/85 (1.18%)  1 2/85 (2.35%)  2
Cystitis klebsiella  1  0/85 (0.00%)  0 1/85 (1.18%)  1
Enterococcal infection  1  1/85 (1.18%)  1 0/85 (0.00%)  0
Escherichia urinary tract infection  1  3/85 (3.53%)  3 2/85 (2.35%)  2
Haemophilus infection  1  2/85 (2.35%)  2 4/85 (4.71%)  4
Klebsiella infection  1  1/85 (1.18%)  1 0/85 (0.00%)  0
Pneumonia haemophilus  1  1/85 (1.18%)  1 1/85 (1.18%)  1
Pneumonia klebsiella  1  0/85 (0.00%)  0 1/85 (1.18%)  1
Pneumonia pneumococca  1  2/85 (2.35%)  2 0/85 (0.00%)  0
Pneumonia pseudomonal  1  1/85 (1.18%)  1 0/85 (0.00%)  0
Proteus infection  1  1/85 (1.18%)  1 0/85 (0.00%)  0
Pseudomonas bronchitis  1  2/85 (2.35%)  2 1/85 (1.18%)  1
Pseudomonas infection  1  0/85 (0.00%)  0 1/85 (1.18%)  1
Staphylococcal impetigo  1  0/85 (0.00%)  0 1/85 (1.18%)  1
Staphylococcal infection  1  3/85 (3.53%)  3 2/85 (2.35%)  2
Tonsillitis bacterial  1  0/85 (0.00%)  0 1/85 (1.18%)  1
Urinary tract infection enterococcal  1  2/85 (2.35%)  2 1/85 (1.18%)  1
Body tinea  1  1/85 (1.18%)  1 0/85 (0.00%)  0
Candida infection  1  1/85 (1.18%)  1 1/85 (1.18%)  1
Oesophageal candidiasis  1  0/85 (0.00%)  0 1/85 (1.18%)  1
Oral candidiasis  1  2/85 (2.35%)  2 1/85 (1.18%)  1
Tinea infection  1  1/85 (1.18%)  1 0/85 (0.00%)  0
Tinea pedis  1  0/85 (0.00%)  0 1/85 (1.18%)  1
Vulvovaginal candidiasis  1  1/85 (1.18%)  1 2/85 (2.35%)  2
Vulvovaginal mycotic infection  1  2/85 (2.35%)  2 0/85 (0.00%)  0
Bronchitis  1  2/85 (2.35%)  2 0/85 (0.00%)  0
Conjunctivitis  1  2/85 (2.35%)  2 2/85 (2.35%)  2
Cystitis  1  1/85 (1.18%)  1 0/85 (0.00%)  0
Diverticulitis  1  0/85 (0.00%)  0 1/85 (1.18%)  1
Ear infection  1  5/85 (5.88%)  5 4/85 (4.71%)  4
Eye infection  1  0/85 (0.00%)  0 2/85 (2.35%)  2
Gastrointestinal infection  1  0/85 (0.00%)  0 1/85 (1.18%)  1
Infection  1  1/85 (1.18%)  1 2/85 (2.35%)  2
Lower respiratory tract infection  1  2/85 (2.35%)  2 7/85 (8.24%)  7
Lung infection  1  0/85 (0.00%)  0 1/85 (1.18%)  1
Mastoiditis  1  0/85 (0.00%)  0 1/85 (1.18%)  1
Otitis media  1  0/85 (0.00%)  0 1/85 (1.18%)  1
Paronychia  1  2/85 (2.35%)  2 0/85 (0.00%)  0
Pharyngitis  1  2/85 (2.35%)  2 2/85 (2.35%)  2
Pneumonia  1  3/85 (3.53%)  3 1/85 (1.18%)  1
Prostate infection  1  1/85 (1.18%)  1 0/85 (0.00%)  0
Respiratory tract infection  1  19/85 (22.35%)  19 31/85 (36.47%)  31
Root canal infection  1  1/85 (1.18%)  1 0/85 (0.00%)  0
Sinusitis  1  15/85 (17.65%)  15 10/85 (11.76%)  10
Skin infection  1  5/85 (5.88%)  5 4/85 (4.71%)  4
Systemic infection  1  0/85 (0.00%)  0 1/85 (1.18%)  1
Tonsillitis  1  1/85 (1.18%)  1 0/85 (0.00%)  0
Tooth abscess  1  1/85 (1.18%)  1 2/85 (2.35%)  2
Tooth infection  1  3/85 (3.53%)  3 0/85 (0.00%)  0
Upper respiratory tract infection  1  17/85 (20.00%)  17 17/85 (20.00%)  17
Urinary tract infection  1  9/85 (10.59%)  9 7/85 (8.24%)  7
Herpes simplex  1  0/85 (0.00%)  0 1/85 (1.18%)  1
Herpes zoster  1  1/85 (1.18%)  1 1/85 (1.18%)  1
Oral herpes  1  0/85 (0.00%)  0 2/85 (2.35%)  2
Respiratory tract infection viral  1  1/85 (1.18%)  1 0/85 (0.00%)  0
Varicella zoster virus infection  1  0/85 (0.00%)  0 1/85 (1.18%)  1
Viral infection  1  1/85 (1.18%)  1 0/85 (0.00%)  0
Investigations     
Streptococcus test positive  1  0/85 (0.00%)  0 1/85 (1.18%)  1
Skin and subcutaneous tissue disorders     
Eczema  1  1/85 (1.18%)  1 0/85 (0.00%)  0
Rosacea  1  0/85 (0.00%)  0 1/85 (1.18%)  1
1
Term from vocabulary, MedDRA (19.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Prof David Jayne
Organization: Cambridge University Hospitals NHS Foundation Trust
Phone: 01223 748062
EMail: dj106@cam.ac.uk
Publications:
Layout table for additonal information
Responsible Party: David Jayne, Cambridge University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01697267    
Other Study ID Numbers: RITAZAREM
2012-001102-14 ( EudraCT Number )
First Submitted: August 31, 2012
First Posted: October 2, 2012
Results First Submitted: March 17, 2021
Results First Posted: March 18, 2022
Last Update Posted: March 18, 2022