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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005889
Receipt No. R000006933
Scientific Title The safety and efficacy of tocilizumab in patients with neuromyelitis optica
Date of disclosure of the study information 2011/07/08
Last modified on 2014/11/27

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Basic information
Public title The safety and efficacy of tocilizumab in patients with neuromyelitis optica
Acronym Tocilizumab in patients with neuromyelitis optica
Scientific Title The safety and efficacy of tocilizumab in patients with neuromyelitis optica
Scientific Title:Acronym Tocilizumab in patients with neuromyelitis optica
Region
Japan

Condition
Condition neuromyelitis optica
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to evaluate safety and efficacy of anti-IL-6R antibody tocilizumab in intractable neuromyelitis optica and to explore mechanism underlying its effectiveness.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes An improvement in MRI lesions, relapsing rate, and EDSS at baseline and 6 months thereafter.
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 6 months.
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 Diagnosis of neuromyelitis optica (NMO), as defined by 2006 criteria published in NEUROLOGY vol. 66 or NMO seropositive spectrum disorder (recurrent optic neuritis or longitudinally extensive transverse myelitis). All patients must be anti-aquaporin 4 antibody seropositive.

Patients with intractable NMO who are resistant to the standard therapy or experiencing sever adverse reactions of the current therapy.

Provision of written informed consent to participate 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 < 4000/mm3), lymphopenia (lymphocyte number < 1000/mm3) or seropositivity for beta-D-glucan in peripheral blood.
7) Pregnant women or patients with possible pregnancy.
8) Patients who can not provide consent to participate in this study by themselves.
9) Patients whose EDSS are more than 7.
Target sample size 3

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
Nationality of Funding Organization

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
2011 Year 07 Month 08 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Completed
Date of protocol fixation
2011 Year 06 Month 30 Day
Date of IRB
Anticipated trial start date
2011 Year 07 Month 01 Day
Last follow-up date
2012 Year 10 Month 11 Day
Date of closure to data entry
2012 Year 10 Month 11 Day
Date trial data considered complete
2013 Year 03 Month 31 Day
Date analysis concluded
2013 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2011 Year 06 Month 30 Day
Last modified on
2014 Year 11 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006933

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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