Unique ID issued by UMIN | UMIN000022201 |
---|---|
Receipt number | 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 13:58:48 |
The efficacy and safety of tocilizumab in patients with neuromyelitis optica
The efficacy and safety of tocilizumab in patients with neuromyelitis optica
The efficacy and safety of tocilizumab in patients with neuromyelitis optica
The efficacy and safety of tocilizumab in patients with neuromyelitis optica
Japan |
neuromyelitis optica
Neurology |
Others
NO
The purpose of this study it to evaluate safety and efficacy of anti-IL-6R antibody tocilizumab in intractable neuromyelitis optica.
Safety,Efficacy
Relapse tate up to years
EDSS up to 2 years
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Tocilizumab it to be infused every 4weeks at 8mg/kg of body weight for 2 years.
20 | years-old | <= |
74 | years-old | >= |
Male and Female
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.
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.
3
1st name | |
Middle name | |
Last name | Chizuko Hamada |
Shimane university hospital
Department of Neurology
89-1, Enya, Izumo, Shimane, 693-8501, japan
0853-20-2198
okuzihc@med.shimane-u.ac.jp
1st name | |
Middle name | |
Last name | Chizuko Hamada |
Shimane University Hospital
Department of Neurology
89-1, Enya, Izumo, Shimane, 693-8501, japan
0853-20-2198
okuzihc@med.shimane-u.ac.jp
Department of Neurology, Shimane University Hospital
Ministry of Health, Labour and Welfare
Japanese Governmental office
NO
2016 | Year | 05 | Month | 04 | Day |
Unpublished
Terminated
2015 | Year | 12 | Month | 11 | Day |
2018 | Year | 12 | Month | 24 | Day |
2016 | Year | 01 | Month | 10 | Day |
2018 | Year | 12 | Month | 24 | Day |
2016 | Year | 05 | Month | 04 | Day |
2019 | Year | 11 | Month | 05 | Day |
Value
https://center6.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 |