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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000012705
Receipt No. R000014841
Scientific Title The efficacy and safety of an anti-interluekin-6 receptor antibody in relapsing-remitting multiple sclerosis
Date of disclosure of the study information 2014/01/07
Last modified on 2016/06/30

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Basic information
Public title The efficacy and safety of an anti-interluekin-6 receptor antibody in relapsing-remitting multiple sclerosis
Acronym Treatment with an anti-interleukin-6 receptor antibody for relapsing-remitting multiple sclerosis
Scientific Title The efficacy and safety of an anti-interluekin-6 receptor antibody in relapsing-remitting multiple sclerosis
Scientific Title:Acronym 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

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

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
1st name
Middle name
Last name Takashi Yamamura
Organization National Institute of Neuroscience, NCNP
Division name Department of Immunology
Zip code
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
1st name
Middle name
Last name Takashi Yamamura
Organization National Institute of Neuroscience, NCNP
Division name Department of Immunology
Zip code
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

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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2013 Year 11 Month 14 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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