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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-001102-14 | EudraCT Number |
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| Name | Class |
|---|---|
| Arthritis Research UK | OTHER |
| Roche Pharma AG | INDUSTRY |
| Genentech, Inc. | INDUSTRY |
| University of Pennsylvania |
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Rituximab is now established as an effective drug for anti-neutrophil cytoplasmic antibody (ANCA) vasculitis following major European and US trials reported in 2010. After a time, its effect wears off and the disease can return. This occurs in at least half of patients within 2 years of receiving Rituximab. A preliminary study in Cambridge has suggested that repeating rituximab every six months stops the disease returning and is safe.
The RITAZAREM trial will find out whether repeating rituximab stops vasculitis returning and whether it works better than the older treatments, azathioprine or methotrexate. It will also tell us how long patients remain well after the repeated rituximab treatments are stopped, and if repeated rituximab is safe. We should also learn useful information about the effects of rituximab on quality of life and economic measures. The trial results will help decide the best treatment for future patients who have their vasculitis initially treated with rituximab.
RITAZAREM aims to recruit patients with established ANCA vasculitis whose disease has come back 'relapsing vasculitis'. All patients will be treated with rituximab and steroids and we anticipate that most will respond well. If their disease is under reasonable control after four months, further treatment with either rituximab (a single dose ever four months for two years) or azathioprine tablets will be chosen randomly. The patients in the rituximab and azathioprine groups will then be compared. Patients will be in the trial for four years.
The study has been designed by members of the European Vasculitis Study group (EUVAS) and the Vasculitis Clinical Research Consortium (VCRC). It will include 190 participants from 30 hospitals in Europe, the USA, Australia and Mexico.
RITAZAREM is being funded by Arthritis Research UK, the U.S. National Institutes of Health and by Roche/Genentech.
Patients will be recruited at the time of relapse. All will receive rituximab 375 mg/m2/week x 4 and glucocorticoids.
Those patients that achieve disease control (BVAS/WG ≤ 1 and daily prednisone dose ≤ 10 mg) by month 4 will be randomised to the rituximab or control remission maintenance groups.
Treatment is protocolised for the entire duration of the study, until the common close date, when the final patient recruited has completed 36 months within the study or until the patient has completed 48 months on study whichever the sooner. Patients in the rituximab arm will receive treatment until month 20, and those in the azathioprine arm until month 27.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rituximab Maintenance | Experimental | Rituximab maintenance: 1g at 4, 8, 12, 16 & 20 months with standardised steroid taper |
|
| Azathioprine Maintenance | Active Comparator | Azathioprine Maintenance: 2mg/kg/day with standardised steroid taper, from month 4 (randomisation) (200 mg maximum daily dose). Azathioprine withdrawn at month 27. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rituximab | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Relapse-free Survival | The primary efficacy outcome measure of the trial is relapse-free survival, where a relapse is either major or minor. The primary analysis will be a Cox regression model adjusted for the stratification factors (ANCA type, relapse severity and prednisone induction regimen) for the difference in the distribution of relapse-free survival between the rituximab arm and the azathioprine (control) arm (two-sided at α-level of 5%). | Any patients who have not relapsed at up to a maximum of 4 years will be censored. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants in Remission at 24 and 48 Months | Proportion of patients who maintain remission at 24 and 48 months | 24 and 48 months |
| Combined Damage Assessment Score (Disease Related Damage Assessment) |
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Inclusion Criteria:
Exclusion Criteria:
Age < 15 years (age < 18 years at centres that do not treat paediatric patients)
Exclusions related to medication:
Previous therapy with:
Exclusions related to general health:
Exclusion criteria related to laboratory parameters:
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| Name | Affiliation | Role |
|---|---|---|
| David Jayne | Cambridge University Hospitals NHS Foundation Trust | Study Chair |
| Peter Merkel | University of Pennsylvania | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States | ||
| University of Michigan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20647295 | Background | Watts RA, Suppiah R, Merkel PA, Luqmani R. Systemic vasculitis--is it time to reclassify? Rheumatology (Oxford). 2011 Apr;50(4):643-5. doi: 10.1093/rheumatology/keq229. Epub 2010 Jul 20. No abstract available. | |
| 20395376 | Background | Falk RJ, Jennette JC. ANCA disease: where is this field heading? J Am Soc Nephrol. 2010 May;21(5):745-52. doi: 10.1681/ASN.2009121238. Epub 2010 Apr 15. |
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Of 188 enrolled participants, 170 met the criteria for randomisation and were randomised for treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 12, 2019 | Mar 17, 2021 |
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| OTHER |
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|
| Azathioprine | Drug | 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 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).
| data in Rows represent the change from randomization (month 4) to months 12, 24, 36, and 48. |
| Cumulative GC Exposure | Cumulative glucocorticoid (GC) exposure during the trial. The trial had a common close out date when the final patient reached month 36 in the trial. Patients were followed until month 48 or the common close out date, whichever happened sooner. Therefore, follow up varied between 36 and 48 months. Cumulative glucocorticoid exposure is presented as a dose in mg for during the treatment period (up to month 24) and across the whole trial (until month 48 or common close out when the final patient reached month 36). | Up to 48 months |
| Severe Adverse Event Rate | Severe adverse event (SAE) rate | Up to 48 months |
| Infection Rates | Infection (treated with intravenous or oral antibiotics) rates | Up to 4 years |
| Health-related Quality of Life Using the SF-36 Physical Composite | The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Scores for the scale range from 0-100 and transformed to have a mean of 50 and SD of 10 in the reference population, with higher scores indicating a better Health-related Quality of Life. | 4 months |
| Health-related Quality of Life Using the SF-36 Mental Composite | The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Scores for the scale range from 0-100 and transformed to have a mean of 50 and SD of 10 in the reference population, with higher scores indicating a better Health-related Quality of Life. | 4 months |
| Health-related Quality of Life Using the SF-36 Physical Composite | The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Scores for the scale range from 0-100 and transformed to have a mean of 50 and SD of 10 in the reference population, with higher scores indicating a better Health-related Quality of Life. | 12 months |
| Health-related Quality of Life Using the SF-36 Mental Composite | The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Scores for the scale range from 0-100 and transformed to have a mean of 50 and SD of 10 in the reference population, with higher scores indicating a better Health-related Quality of Life. | 12 months |
| Health-related Quality of Life Using the SF-36 Physical Composite | The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Scores for the scale range from 0-100 and transformed to have a mean of 50 and SD of 10 in the reference population, with higher scores indicating a better Health-related Quality of Life. | 24 months |
| Health-related Quality of Life Using the SF-36 Mental Composite | The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Scores for the scale range from 0-100 and transformed to have a mean of 50 and SD of 10 in the reference population, with higher scores indicating a better Health-related Quality of Life. | 24 months |
| Health-related Quality of Life Using the SF-36 Physical Composite | The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Scores for the scale range from 0-100 and transformed to have a mean of 50 and SD of 10 in the reference population, with higher scores indicating a better Health-related Quality of Life. | 36 months |
| Health-related Quality of Life Using the SF-36 Mental Composite | The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Scores for the scale range from 0-100 and transformed to have a mean of 50 and SD of 10 in the reference population, with higher scores indicating a better Health-related Quality of Life. | 36 months |
| Health-related Quality of Life Using the SF-36 Physical Composite | The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Scores for the scale range from 0-100 and transformed to have a mean of 50 and SD of 10 in the reference population, with higher scores indicating a better Health-related Quality of Life. | 48 months |
| Health-related Quality of Life Using the SF-36 Mental Composite | The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Scores for the scale range from 0-100 and transformed to have a mean of 50 and SD of 10 in the reference population, with higher scores indicating a better Health-related Quality of Life. | 48 months |
| Ann Arbor |
| Michigan |
| 48109 |
| United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Hospital for Special Surgery | New York | New York | 10021 | United States |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15260 | United States |
| University of Utah | Salt Lake City | Utah | 84112 | United States |
| Canberra Hospital | Garran | Australian Capital Territory | Australia |
| Royal Brisbane & Women's Hospital | Herston | Queensland | 4029 | Australia |
| Royal Adelaide Hospital | Adelaide | South Australia | Australia |
| St. Joseph's Healthcare | Hamilton | Ontario | L8N 4A6 | Canada |
| Mount Sinai Hospital | Toronto | Ontario | M5T 3L9 | Canada |
| General Faculty Hospital | Prague | Czechia |
| Cork University Hospital | Cork | Ireland |
| University Hospital of Parma | Parma | 43100 | Italy |
| Okayama University | Kita-ku | Okayama-ken | 700-0082 | Japan |
| Chiba University | Chiba | 263-8522 | Japan |
| Kitano Hospital | Kyoto | 606-8501 | Japan |
| University of Miyazaki | Miyazaki | 889-2192 | Japan |
| Teikyo University | Tokyo | 173-0003 | Japan |
| Tokyo Metropolitan Geriatric | Tokyo | 173-0015 | Japan |
| Kyorin University school of medicine | Tokyo | 192-0005 | Japan |
| Auckland City Hospital | Grafton | Auckland | 1023 | New Zealand |
| North Shore Hospital | Westlake | Auckland | New Zealand |
| Karolinska University Hospital | Stockholm | Sweden |
| Leicester General Hospital | Leicester | Leicestershire | LE5 4PW | United Kingdom |
| Queen Elizabeth Hospital | Birmingham | B15 2WB | United Kingdom |
| Brighton and Sussex University Hospitals | Brighton | BN2 5BE | United Kingdom |
| Addenbrooke's Hospital | Cambridge | CB2 0QQ | United Kingdom |
| Russells Hall Hospital | Dudley | DY1 2HQ | United Kingdom |
| Ipswich Hospital | Ipswich | IP4 5PD | United Kingdom |
| Chapel Allerton Hospital | Leeds | LS7 4SA | United Kingdom |
| Imperial College | London | W12 0NN | United Kingdom |
| James Cook University Hospital | Middlesbrough | TS4 3BW | United Kingdom |
| Queen's Medical Centre Campus, Nottingham University Hosp | Nottingham | NG7 2UH | United Kingdom |
| University of Oxford | Oxford | OX1 2JD | United Kingdom |
| 12496504 | Background | Watts RA, Scott DG. Epidemiology of the vasculitides. Curr Opin Rheumatol. 2003 Jan;15(1):11-6. doi: 10.1097/00002281-200301000-00003. |
| 12666064 | Background | Booth AD, Almond MK, Burns A, Ellis P, Gaskin G, Neild GH, Plaisance M, Pusey CD, Jayne DR; Pan-Thames Renal Research Group. Outcome of ANCA-associated renal vasculitis: a 5-year retrospective study. Am J Kidney Dis. 2003 Apr;41(4):776-84. doi: 10.1016/s0272-6386(03)00025-8. |
| 12840090 | Background | Jayne D, Rasmussen N, Andrassy K, Bacon P, Tervaert JW, Dadoniene J, Ekstrand A, Gaskin G, Gregorini G, de Groot K, Gross W, Hagen EC, Mirapeix E, Pettersson E, Siegert C, Sinico A, Tesar V, Westman K, Pusey C; European Vasculitis Study Group. A randomized trial of maintenance therapy for vasculitis associated with antineutrophil cytoplasmic autoantibodies. N Engl J Med. 2003 Jul 3;349(1):36-44. doi: 10.1056/NEJMoa020286. |
| 19451574 | Background | de Groot K, Harper L, Jayne DR, Flores Suarez LF, Gregorini G, Gross WL, Luqmani R, Pusey CD, Rasmussen N, Sinico RA, Tesar V, Vanhille P, Westman K, Savage CO; EUVAS (European Vasculitis Study Group). Pulse versus daily oral cyclophosphamide for induction of remission in antineutrophil cytoplasmic antibody-associated vasculitis: a randomized trial. Ann Intern Med. 2009 May 19;150(10):670-80. doi: 10.7326/0003-4819-150-10-200905190-00004. |
| 16052573 | Background | De Groot K, Rasmussen N, Bacon PA, Tervaert JW, Feighery C, Gregorini G, Gross WL, Luqmani R, Jayne DR. Randomized trial of cyclophosphamide versus methotrexate for induction of remission in early systemic antineutrophil cytoplasmic antibody-associated vasculitis. Arthritis Rheum. 2005 Aug;52(8):2461-9. doi: 10.1002/art.21142. |
| 15673801 | Background | Wegener's Granulomatosis Etanercept Trial (WGET) Research Group. Etanercept plus standard therapy for Wegener's granulomatosis. N Engl J Med. 2005 Jan 27;352(4):351-61. doi: 10.1056/NEJMoa041884. |
| 15986348 | Background | Seo P, Min YI, Holbrook JT, Hoffman GS, Merkel PA, Spiera R, Davis JC, Ytterberg SR, St Clair EW, McCune WJ, Specks U, Allen NB, Luqmani RA, Stone JH; WGET Research Group. Damage caused by Wegener's granulomatosis and its treatment: prospective data from the Wegener's Granulomatosis Etanercept Trial (WGET). Arthritis Rheum. 2005 Jul;52(7):2168-78. doi: 10.1002/art.21117. |
| 7506951 | Background | Reff ME, Carner K, Chambers KS, Chinn PC, Leonard JE, Raab R, Newman RA, Hanna N, Anderson DR. Depletion of B cells in vivo by a chimeric mouse human monoclonal antibody to CD20. Blood. 1994 Jan 15;83(2):435-45. |
| 20647198 | Background | Jones RB, Tervaert JW, Hauser T, Luqmani R, Morgan MD, Peh CA, Savage CO, Segelmark M, Tesar V, van Paassen P, Walsh D, Walsh M, Westman K, Jayne DR; European Vasculitis Study Group. Rituximab versus cyclophosphamide in ANCA-associated renal vasculitis. N Engl J Med. 2010 Jul 15;363(3):211-20. doi: 10.1056/NEJMoa0909169. |
| 20647199 | Background | Stone JH, Merkel PA, Spiera R, Seo P, Langford CA, Hoffman GS, Kallenberg CG, St Clair EW, Turkiewicz A, Tchao NK, Webber L, Ding L, Sejismundo LP, Mieras K, Weitzenkamp D, Ikle D, Seyfert-Margolis V, Mueller M, Brunetta P, Allen NB, Fervenza FC, Geetha D, Keogh KA, Kissin EY, Monach PA, Peikert T, Stegeman C, Ytterberg SR, Specks U; RAVE-ITN Research Group. Rituximab versus cyclophosphamide for ANCA-associated vasculitis. N Engl J Med. 2010 Jul 15;363(3):221-32. doi: 10.1056/NEJMoa0909905. |
| 19565480 | Background | Jones RB, Ferraro AJ, Chaudhry AN, Brogan P, Salama AD, Smith KG, Savage CO, Jayne DR. A multicenter survey of rituximab therapy for refractory antineutrophil cytoplasmic antibody-associated vasculitis. Arthritis Rheum. 2009 Jul;60(7):2156-68. doi: 10.1002/art.24637. |
| 36958796 | Derived | Smith RM, Jones RB, Specks U, Bond S, Nodale M, Al-Jayyousi R, Andrews J, Bruchfeld A, Camilleri B, Carette S, Cheung CK, Derebail V, Doulton T, Ferraro A, Forbess L, Fujimoto S, Furuta S, Gewurz-Singer O, Harper L, Ito-Ihara T, Khalidi N, Klocke R, Koening C, Komagata Y, Langford C, Lanyon P, Luqmani R, McAlear C, Moreland LW, Mynard K, Nachman P, Pagnoux C, Peh CA, Pusey C, Ranganathan D, Rhee RL, Spiera R, Sreih AG, Tesar V, Walters G, Wroe C, Jayne D, Merkel PA; RITAZAREM co-investigators. Rituximab versus azathioprine for maintenance of remission for patients with ANCA-associated vasculitis and relapsing disease: an international randomised controlled trial. Ann Rheum Dis. 2023 Jul;82(7):937-944. doi: 10.1136/ard-2022-223559. Epub 2023 Mar 23. |
| 28270229 | Derived | Gopaluni S, Smith RM, Lewin M, McAlear CA, Mynard K, Jones RB, Specks U, Merkel PA, Jayne DR; RITAZAREM Investigators. Rituximab versus azathioprine as therapy for maintenance of remission for anti-neutrophil cytoplasm antibody-associated vasculitis (RITAZAREM): study protocol for a randomized controlled trial. Trials. 2017 Mar 7;18(1):112. doi: 10.1186/s13063-017-1857-z. |
| 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%. |
| Month 24 |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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%. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||||
| ANCA type | 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). | Count of Participants | Participants |
| |||||||||||||||||
| Prednisone Induction Regimen | 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. | Count of Participants | Participants |
| |||||||||||||||||
| Relapse type | 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 | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Relapse-free Survival | The primary efficacy outcome measure of the trial is relapse-free survival, where a relapse is either major or minor. The primary analysis will be a Cox regression model adjusted for the stratification factors (ANCA type, relapse severity and prednisone induction regimen) for the difference in the distribution of relapse-free survival between the rituximab arm and the azathioprine (control) arm (two-sided at α-level of 5%). | Posted | Number | participants | Any patients who have not relapsed at up to a maximum of 4 years will be censored. |
|
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants in Remission at 24 and 48 Months | Proportion of patients who maintain remission at 24 and 48 months | Posted | Count of Participants | Participants | 24 and 48 months |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Combined Damage Assessment Score (Disease Related Damage Assessment) | Cumulative accrual of damage as measured by the combined damage assessment score (CDA). Each persistent or new occurrence of damage is given a score of 1. The cumulative accrual of damage is obtained by summing across the different types of damage to get an overall score (max score = 64). | Posted | Mean | Standard Deviation | score on a scale | data in Rows represent the change from randomization (month 4) to months 12, 24, 36, and 48. |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Cumulative GC Exposure | Cumulative glucocorticoid (GC) exposure during the trial. The trial had a common close out date when the final patient reached month 36 in the trial. Patients were followed until month 48 or the common close out date, whichever happened sooner. Therefore, follow up varied between 36 and 48 months. Cumulative glucocorticoid exposure is presented as a dose in mg for during the treatment period (up to month 24) and across the whole trial (until month 48 or common close out when the final patient reached month 36). | Posted | Mean | Standard Deviation | mg | Up to 48 months |
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| Secondary | Severe Adverse Event Rate | Severe adverse event (SAE) rate | Posted | Count of Participants | Participants | Up to 48 months |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Infection Rates | Infection (treated with intravenous or oral antibiotics) rates | Posted | Count of Participants | Participants | Up to 4 years |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Health-related Quality of Life Using the SF-36 Physical Composite | The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Scores for the scale range from 0-100 and transformed to have a mean of 50 and SD of 10 in the reference population, with higher scores indicating a better Health-related Quality of Life. | Posted | Mean | Standard Deviation | score on a scale | 4 months |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Health-related Quality of Life Using the SF-36 Mental Composite | The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Scores for the scale range from 0-100 and transformed to have a mean of 50 and SD of 10 in the reference population, with higher scores indicating a better Health-related Quality of Life. | Posted | Mean | Standard Deviation | score on a scale | 4 months |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Health-related Quality of Life Using the SF-36 Physical Composite | The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Scores for the scale range from 0-100 and transformed to have a mean of 50 and SD of 10 in the reference population, with higher scores indicating a better Health-related Quality of Life. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Health-related Quality of Life Using the SF-36 Mental Composite | The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Scores for the scale range from 0-100 and transformed to have a mean of 50 and SD of 10 in the reference population, with higher scores indicating a better Health-related Quality of Life. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Health-related Quality of Life Using the SF-36 Physical Composite | The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Scores for the scale range from 0-100 and transformed to have a mean of 50 and SD of 10 in the reference population, with higher scores indicating a better Health-related Quality of Life. | Posted | Mean | Standard Deviation | score on a scale | 24 months |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Health-related Quality of Life Using the SF-36 Mental Composite | The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Scores for the scale range from 0-100 and transformed to have a mean of 50 and SD of 10 in the reference population, with higher scores indicating a better Health-related Quality of Life. | Posted | Mean | Standard Deviation | score on a scale | 24 months |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Health-related Quality of Life Using the SF-36 Physical Composite | The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Scores for the scale range from 0-100 and transformed to have a mean of 50 and SD of 10 in the reference population, with higher scores indicating a better Health-related Quality of Life. | Posted | Mean | Standard Deviation | score on a scale | 36 months |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Health-related Quality of Life Using the SF-36 Mental Composite | The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Scores for the scale range from 0-100 and transformed to have a mean of 50 and SD of 10 in the reference population, with higher scores indicating a better Health-related Quality of Life. | Posted | Mean | Standard Deviation | score on a scale | 36 months |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Health-related Quality of Life Using the SF-36 Physical Composite | The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Scores for the scale range from 0-100 and transformed to have a mean of 50 and SD of 10 in the reference population, with higher scores indicating a better Health-related Quality of Life. | Posted | Mean | Standard Deviation | score on a scale | 48 months |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Health-related Quality of Life Using the SF-36 Mental Composite | The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Scores for the scale range from 0-100 and transformed to have a mean of 50 and SD of 10 in the reference population, with higher scores indicating a better Health-related Quality of Life. | Posted | Mean | Standard Deviation | score on a scale | 48 months |
|
Adverse events were collected for up to 48 months or until the last patient recruited reached Month 36.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 3 | 85 | 19 | 85 | 42 | 85 |
| EG001 | 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%. | 1 | 85 | 31 | 85 | 43 | 85 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Periorbital oedema | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Oesophageal spasm | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Enterovesical fistula | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Perforated ulcer | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Stenosis | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pulmonary vasculitis | Immune system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Vasculitis | Immune system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Dacryocystitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Pneumonia klebsiella | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Periorbital abscess | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Infective exacerbation of chronic obstructive airways disease | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Metapneumovirus infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Accident | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| Intra-abdominal haemorrhage | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| Vascular access complication | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| Medical observation | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Myasthenia gravis | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Myasthenia gravis crisis | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pubis fracture | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Bladder papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| Pancreatic carcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| Sarcoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| Colon neoplasm 1 | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| Anal squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| Haemorrhagic stroke | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Sleep apnoea syndrome | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Subdural haemorrhage | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Conversion disorder | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Laryngeal stenosis | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Stridor | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pneumomediastinum | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Aortic valve replacement | Surgical and medical procedures | MedDRA (19.0) | Systematic Assessment |
| |
| Bunion operation | Surgical and medical procedures | MedDRA (19.0) | Systematic Assessment |
| |
| Cholecystectomy | Surgical and medical procedures | MedDRA (19.0) | Systematic Assessment |
| |
| Colostomy closure | Surgical and medical procedures | MedDRA (19.0) | Systematic Assessment |
| |
| Dacryocystorhinostomy | Surgical and medical procedures | MedDRA (19.0) | Systematic Assessment |
| |
| Hip arthroplasty | Surgical and medical procedures | MedDRA (19.0) | Systematic Assessment |
| |
| Knee arthroplasty | Surgical and medical procedures | MedDRA (19.0) | Systematic Assessment |
| |
| Lung lobectomy | Surgical and medical procedures | MedDRA (19.0) | Systematic Assessment |
| |
| Renal transplant | Surgical and medical procedures | MedDRA (19.0) | Systematic Assessment |
| |
| Spinal decompression | Surgical and medical procedures | MedDRA (19.0) | Systematic Assessment |
| |
| Renal and pancreas transplant | Surgical and medical procedures | MedDRA (19.0) | Systematic Assessment |
| |
| Sigmoidectomy | Surgical and medical procedures | MedDRA (19.0) | Systematic Assessment |
| |
| Cardiac ablation | Surgical and medical procedures | MedDRA (19.0) | Systematic Assessment |
| |
| Infusion | Surgical and medical procedures | MedDRA (19.0) | Systematic Assessment |
| |
| Colporrhaphy | Surgical and medical procedures | MedDRA (19.0) | Systematic Assessment |
| |
| Thyroidectomy | Surgical and medical procedures | MedDRA (19.0) | Systematic Assessment |
| |
| Joint resurfacing surgery | Surgical and medical procedures | MedDRA (19.0) | Systematic Assessment |
| |
| Vascular anastomosis | Surgical and medical procedures | MedDRA (19.0) | Systematic Assessment |
| |
| Epistaxis | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Haemoptysis | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pulmonary embolism | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Vascular injury | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Vascular pseudoaneurysm | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Malaise | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Bacterial dacryocystitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Beta haemolytic streptococcal infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Bronchitis haemophilus | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Cellulitis orbital | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Citrobacter infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Cystitis escherichia | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Cystitis klebsiella | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Enterococcal infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Haemophilus infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Klebsiella infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Pneumonia haemophilus | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Pneumonia klebsiella | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Pneumonia pneumococca | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Pneumonia pseudomonal | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Proteus infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Pseudomonas bronchitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Pseudomonas infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Staphylococcal impetigo | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Tonsillitis bacterial | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Urinary tract infection enterococcal | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Body tinea | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Oesophageal candidiasis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Tinea infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Tinea pedis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Vulvovaginal candidiasis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Eye infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Mastoiditis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Prostate infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Root canal infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Systemic infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Varicella zoster virus infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Streptococcus test positive | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Rosacea | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof David Jayne | Cambridge University Hospitals NHS Foundation Trust | 01223 748062 | dj106@cam.ac.uk |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 25, 2021 | Jun 22, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D056648 | Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis |
| D055953 | Microscopic Polyangiitis |
| D014890 | Granulomatosis with Polyangiitis |
| D014657 | Vasculitis |
| ID | Term |
|---|---|
| D056647 | Systemic Vasculitis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D059345 | Cerebral Small Vessel Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069283 | Rituximab |
| D001379 | Azathioprine |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D013872 | Thionucleosides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D015122 | Mercaptopurine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Black |
|
| Asian |
|
| Hispanic |
|
| Other |
|
| Sweden |
|
| United States |
|
| Czechia |
|
| Japan |
|
| United Kingdom |
|
| Australia |
|
| anti-MPO |
|
| 1B (starting dose 0.5mg/kg/day) |
|
| Non-severe |
|
| Total number of patients with a relapse post treatment |
|
| Participants |
|
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| Participants |
|
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