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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-UMIN000022201 |
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Date of registration:
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04/05/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The efficacy and safety of tocilizumab in patients with neuromyelitis optica
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Scientific title:
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The efficacy and safety of tocilizumab in patients with neuromyelitis optica - The efficacy and safety of tocilizumab in patients with neuromyelitis optica |
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Date of first enrolment:
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2016/01/10 |
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Target sample size:
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3 |
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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=R000025575 |
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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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Chizuko Hamada |
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Address:
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89-1, Enya, Izumo, Shimane, 693-8501, japan
Japan |
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Telephone:
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0853-20-2198 |
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Email:
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okuzihc@med.shimane-u.ac.jp |
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Affiliation:
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Shimane University Hospital Department of Neurology |
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Name:
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Chizuko Hamada |
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Address:
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89-1, Enya, Izumo, Shimane, 693-8501, japan
Japan |
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Telephone:
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0853-20-2198 |
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Email:
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okuzihc@med.shimane-u.ac.jp |
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Affiliation:
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Shimane university hospital Department of Neurology |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 1)Patients with severe infection such at tuberculosis, pneumocystis carinii pneumonia, nontuberculosis mycobacterial infection, hepatitis B,hepatitis C, or chronic active FB virus infection. 2)Patients with a history of hypersensitivity to this drug. 3)Patients with interstitial pneumoniris. 4)Patients with lymphopenia.(lymphocyte number <500/mm3) 5)Pregnant women or patients with possible pregnancy.
Age minimum:
20years-old
Age maximum:
74years-old
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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neuromyelitis optica
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Intervention(s)
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Tocilizumab it to be infused every 4weeks at 8mg/kg of body weight for 2 years.
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Primary Outcome(s)
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Relapse tate up to years EDSS up to 2 years
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Source(s) of Monetary Support
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Ministry of Health, Labour and Welfare
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Ethics review
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Status: YES
Approval date: 24/12/2018
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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24/12/2018 |
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URL:
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