Tocilizumab in patients with neuromyelitis optica

JRCT ID: jRCTs031180152

Registered date:25/02/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Neuromyelitis optica
• Date of first enrollment: 04/06/2012
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Tocilizumab is to be infused every 4 weeks at 8 mg/kg of body weight for 6 months.

Outcome(s)

Primary Outcome

1) Adverse events after the initiation of TCZ
2) Relapsing rate after the initiation of TCZ, as compared to pretreatment period

Secondary Outcome

1) EDSS/FS
2) Neurological findings (neurological examination, visual acuity, VAS(1), Critical flicker frequency(2), VEP(3), SSEP(4), ABR(5), Motor functional and sensory functional test)
3) New lesions in brain and spinal cord MRI
4) Cerebral spinal fluid cytokine profiles
5) Anti-aquaporin 4 antibody titer
6) Plasmablast frequency
7) T cell cytokine profile
8) Gut microbiota

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 65age old
• Gender: Both

Include 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.

History of at least one relapse during the 1 year prior to initiation of this study.

Provision of written informed consent to participate in this study.

Exclude criteria

1) Patients with severe infection
tuberculosis, pneumocystis carinii pneumonia, nontuberculous mycobacterial infection (diagnosed by tuberculin test, beta-D glucan,chest X-ray)
When the tuberculin test shows intermediate or strong positivity, or the patients have a clinical history of contact with a patient with tuberculosis, isoniazid or rifampicin at a dose of 300 mg once daily for 6 to 9 months with pyridoxal at a dose of 10mg once daily initiated 3 weeks prior to tocilizumab.
Immunocompromised host
2) hepatitis B (positivity for HBS Ag and HBC Ab, hepatitis C (positivity for HCV Ab), or chronic active EB virus infection.
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 less than 4000/mm3), lymphopenia (lymphocyte number less than 500/mm3) or seropositivity for beta-D-glucan in peripheral blood.
7) Pregnant women or patients with possible pregnancy.
8) Patients aged older than 20 and younger than 66 years.
9) Patients with a history of allergic reaction to tocilizumab.
10) Patients who cannot provide consent to participate in this study by themselves.
11) Patients whose EDSS are more than 7.

Related Information

• Primary Sponsor: Yamamura Takashi
• Source(s) of Monetary Support: Chugai Pharmaceutical Co. Ltd.,National Center of Neurology and Psychiatry
• Secondary ID(s): UMIN000005889