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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-UMIN000012705 |
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Date of registration:
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07/01/2014 |
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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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The efficacy and safety of an anti-interluekin-6 receptor antibody in relapsing-remitting multiple sclerosis
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Scientific title:
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The efficacy and safety of an anti-interluekin-6 receptor antibody in relapsing-remitting multiple sclerosis - Treatment with an anti-interleukin-6 receptor antibody for relapsing-remitting multiple sclerosis |
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Date of first enrolment:
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2014/01/07 |
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Target sample size:
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10 |
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Recruitment status: |
Recruiting |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014841 |
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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 applicable
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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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Takashi Yamamura |
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Address:
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4-1-1, Ogawahigashi, Kodaira, Tokyo 187-8502, Japan
Japan |
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Telephone:
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042-341-2711 |
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Email:
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yamamura@ncnp.go.jp |
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Affiliation:
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National Institute of Neuroscience, NCNP Department of Immunology |
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Name:
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Takashi Yamamura |
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Address:
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4-1-1, Ogawahigashi, Kodaira, Tokyo 187-8502, Japan
Japan |
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Telephone:
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042-341-2711 |
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Email:
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yamamura@ncnp.go.jp |
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Affiliation:
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National Institute of Neuroscience, NCNP Department of Immunology |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 1) Patients with severe infection such as tuberculosis, pneumocystis carinii pneumonia, nontuberculous mycobacterial infection, hepatitis B, hepatitis C, or chronic active EB virus infection. 2) Patients with a history of tuberculosis infection or patients with pleural thickness or old tuberculin in chest X-ray. 3) Patients with a history of hypersensitivity to this drug. 4) Patients with a history of intestinal diverticulum. 5) Patients with interstitial pneumonitis. 6) Patients with leukopenia (white blood cell number < 3500/mm3), lymphopenia (lymphocyte number < 500/mm3) or seropositivity for beta-D-glucan in peripheral blood. 7) Pregnant women or patients with possible pregnancy. 8) Patients with a history of allergy to this drug 9) Patients who can not provide consent to participate in this study by themselves.
Age minimum:
20years-old
Age maximum:
65years-old
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Relapsing-remitting multiple sclerosis
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Intervention(s)
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Tocilizumab is to be infused every 4 weeks at 8 mg/kg of body weight for 2 years.
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Primary Outcome(s)
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-Relapse rate, disability (EDSS), and MRI parameters up to 1 or 2 years. -Adverse events up to 1 or 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:
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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