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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-UMIN000007019 |
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Date of registration:
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01/02/2012 |
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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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Efficacy and safety of tocilizumab mono-therapy in patients with adult-onset Still's disease
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Scientific title:
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Efficacy and safety of tocilizumab mono-therapy in patients with adult-onset Still's disease - Treatment of AOSD by tocilizumab mono-therapy |
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Date of first enrolment:
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2012/02/01 |
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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=R000008277 |
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Study type:
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Interventional |
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Study design:
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Single arm Non-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 Universitity Department of Rheumatology & 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 |
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Telephone:
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049-228-3859 |
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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 the treatment with tocilizumab by their attending doctor
Age minimum:
16years-old
Age maximum:
70years-old
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Rheumatoid arthritis
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Intervention(s)
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tocilizumab monotherapy
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Primary Outcome(s)
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Improvement of major clinical signs and symptoms at week 12 and 28 (fever, arthritis,skin eruption, leukocytosis, serum ferritin)
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Secondary Outcome(s)
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Improvement of major clinical signs,treatment survival rate,patient's global assessment(by VAS),relapse rate and adverse events at week 52 and 104
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Source(s) of Monetary Support
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Saitama Medical Center, Saitama Medical Universitity
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Ethics review
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Status: YES
Approval date:
Contact:
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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01/03/2018 |
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URL:
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