UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The efficacy and safety of an anti-interluekin-6 receptor antibody in relapsing-remitting multiple sclerosis
Title of the study (Brief title)	Treatment with an anti-interleukin-6 receptor antibody for relapsing-remitting multiple sclerosis
Region	Japan

Condition
Condition	Relapsing-remitting multiple sclerosis
Classification by specialty	Neurology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to evaluate the efficacy and safety of anti-IL-6R antibody tocilizumab in relapsing-remitting multiple sclerosis with a high plasmablast frequency in peripheral blood and to explore its mechanism of action.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	-Relapse rate, disability (EDSS), and MRI parameters up to 1 or 2 years. -Adverse events up to 1 or 2 years.
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Tocilizumab is to be infused every 4 weeks at 8 mg/kg of body weight for 2 years.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	65 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Diagnosis as relapsing-remitting multiple sclerosis (RRMS) according to 2010 revised McDonald criteria (Ann Neurol 2011; 69: 292-302). 2. Intractable patients with RRMS resistant to standard therapies other than tocilizumab with more than two relapses or disability progression during the 1 year prior to initiation to this study. 3. With a higher plasmablast frequency in peripheral blood than the mean frequency + 2SD in healthy donors by flow cytometry. 4. Provision of written informed consent to participate in this study. 5. Since a relapsing-remitting phase could turn out to be a secondary-progressive phase after the entry, the patients with secondary-progressive MS (SPMS) could be included in this study.
Key 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.
Target sample size	10

Research contact person
Name of lead principal investigator	Takashi Yamamura
Organization	National Institute of Neuroscience, NCNP
Division name	Department of Immunology
Address	4-1-1, Ogawahigashi, Kodaira, Tokyo 187-8502, Japan
TEL	042-341-2711
Email	yamamura@ncnp.go.jp

Public contact
Name of contact person	Takashi Yamamura
Organization	National Institute of Neuroscience, NCNP
Division name	Department of Immunology
Address	4-1-1, Ogawahigashi, Kodaira, Tokyo 187-8502, Japan
TEL	042-341-2711
Homepage URL
Email	yamamura@ncnp.go.jp

Sponsor
Institute	Department of Immunology, National Institute of Neuroscience, NCNP
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2014 Year 01 Month 07 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2013 Year 11 Month 14 Day
Anticipated trial start date	2014 Year 01 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 12 Month 26 Day
Last modified on	2016 Year 06 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014841