UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005889 |
|---|---|
| Receipt number | 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 16:56:19 |
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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
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
yamamura@ncnp.go.jp
Sponsor or person
Institute
Department of Immunology, National Institute of Neuroscience, NCNP
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006933
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