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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000022201
Receipt No. R000025575
Scientific Title The efficacy and safety of tocilizumab in patients with neuromyelitis optica
Date of disclosure of the study information 2016/05/04
Last modified on 2019/11/05

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Basic information
Public title The efficacy and safety of tocilizumab in patients with neuromyelitis optica
Acronym The efficacy and safety of tocilizumab in patients with neuromyelitis optica
Scientific Title The efficacy and safety of tocilizumab in patients with neuromyelitis optica
Scientific Title:Acronym The efficacy and safety of 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 it to evaluate safety and efficacy of anti-IL-6R antibody tocilizumab in intractable neuromyelitis optica.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Relapse tate up to years
EDSS up to 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 it to be infused every 4weeks at 8mg/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
74 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.All patients must be anti-aquaporin4 antibody seropositive. They also have resistance or cannot continue nomal treatment because of side effects.
Key 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.
Target sample size 3

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Chizuko Hamada
Organization Shimane university hospital
Division name Department of Neurology
Zip code
Address 89-1, Enya, Izumo, Shimane, 693-8501, japan
TEL 0853-20-2198
Email okuzihc@med.shimane-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Chizuko Hamada
Organization Shimane University Hospital
Division name Department of Neurology
Zip code
Address 89-1, Enya, Izumo, Shimane, 693-8501, japan
TEL 0853-20-2198
Homepage URL
Email okuzihc@med.shimane-u.ac.jp

Sponsor
Institute Department of Neurology, Shimane University Hospital
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization Japanese Governmental office
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
2016 Year 05 Month 04 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 Terminated
Date of protocol fixation
2015 Year 12 Month 11 Day
Date of IRB
2018 Year 12 Month 24 Day
Anticipated trial start date
2016 Year 01 Month 10 Day
Last follow-up date
2018 Year 12 Month 24 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 05 Month 04 Day
Last modified on
2019 Year 11 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025575

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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