Rituximab Vasculitis Maintenance Study (RITAZAREM)
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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
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Study Type | Interventional |
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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 |
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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 Azathioprine withdrawn at month 27.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 The dose should then by reduced by 50% and azathioprine completely withdrawn at month 27.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 | |
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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 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 85 participants | 85 participants | 170 participants | |
<=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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Between 18 and 65 years |
54 63.5%
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51 60.0%
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105 61.8%
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>=65 years |
31 36.5%
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34 40.0%
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65 38.2%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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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 |
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Number Analyzed | 85 participants | 85 participants | 170 participants | |
Female |
42 49.4%
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44 51.8%
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86 50.6%
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Male |
43 50.6%
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41 48.2%
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84 49.4%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 85 participants | 85 participants | 170 participants |
White |
78 91.8%
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77 90.6%
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155 91.2%
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Black |
0 0.0%
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0 0.0%
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0 0.0%
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Asian |
5 5.9%
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5 5.9%
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10 5.9%
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Hispanic |
2 2.4%
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1 1.2%
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3 1.8%
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Other |
0 0.0%
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2 2.4%
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2 1.2%
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Region of Enrollment
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 85 participants | 85 participants | 170 participants |
Canada |
13 15.3%
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11 12.9%
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24 14.1%
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Sweden |
3 3.5%
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2 2.4%
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5 2.9%
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United States |
26 30.6%
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22 25.9%
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48 28.2%
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Czechia |
0 0.0%
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1 1.2%
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1 0.6%
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Japan |
2 2.4%
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2 2.4%
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4 2.4%
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United Kingdom |
36 42.4%
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42 49.4%
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78 45.9%
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Australia |
5 5.9%
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5 5.9%
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10 5.9%
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ANCA type
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 85 participants | 85 participants | 170 participants | |
anti-PR3 |
61 71.8%
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62 72.9%
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123 72.4%
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anti-MPO |
24 28.2%
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23 27.1%
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47 27.6%
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[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).
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Prednisone Induction Regimen
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 85 participants | 85 participants | 170 participants | |
1A (starting dose 1mg/kg/day) |
24 28.2%
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24 28.2%
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48 28.2%
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1B (starting dose 0.5mg/kg/day) |
61 71.8%
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61 71.8%
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122 71.8%
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[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. |
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Relapse type
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 85 participants | 85 participants | 170 participants | |
Severe |
52 61.2%
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54 63.5%
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106 62.4%
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Non-severe |
33 38.8%
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31 36.5%
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64 37.6%
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[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
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Name/Title: | Prof David Jayne |
Organization: | Cambridge University Hospitals NHS Foundation Trust |
Phone: | 01223 748062 |
EMail: | dj106@cam.ac.uk |
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 |