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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000011244 |
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Date of registration:
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01/09/2013 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A prospective, open label, randomized, controlled trial of tocilizumab versus cyclophosphamide in patients with microscopic polyangiitis
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Scientific title:
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A prospective, open label, randomized, controlled trial of tocilizumab versus cyclophosphamide in patients with microscopic polyangiitis - Tocilizumab versus cyclophosphamide in microscopic polyangiitis |
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Date of first enrolment:
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2013/09/01 |
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Target sample size:
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40 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013180 |
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Study type:
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Interventional |
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Study design:
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Parallel Randomized
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Phase:
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Not selected
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Countries of recruitment
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Japan
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Contacts
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Name:
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Ryota Sakai |
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Address:
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1981 Kamoda, Kawagoe, Saitama, 350-8550, Japan
Japan |
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Telephone:
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0492283574 |
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Email:
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r_sakai@saitama-med.ac.jp |
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Affiliation:
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Saitama Medical Center, Saitama Medical University Department of Rheumatology and Clinical Immunology |
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Name:
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Koichi Amano |
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Address:
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1981 Kamoda, Kawagoe, Saitama, 350-8550, Japan
Japan |
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Telephone:
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0492283859 |
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Email:
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amanokoi@saitama-med.ac.jp |
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Affiliation:
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Saitama Medical Center, Saitama Medical University Department of Rheumatology and Clinical Immunology |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 1) patients who are prohibited to use tocilizumab by the JCR guideline for proper tocilizumab use 2) patients who are thought to be inappropriate for tocilizumab by their attending doctor
Age minimum:
20years-old
Age maximum:
80years-old
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Microscopic polyangiitis
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Intervention(s)
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Tocilizumab group
Cyclophosphamide group
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Primary Outcome(s)
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Improvement of major clinical signs and symptoms at week 24. (MPO-ANCA or PR3-ANCA, serum CRP and ESR, BVAS2003, VDI)
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Source(s) of Monetary Support
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Saitama Medical Center, Saitama Medical University Department of Rheumatology and Clinical Immunology
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Ethics review
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Status: NO
Approval date:
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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