Treatment with an anti-interleukin-6 receptor antibody for multiple sclerosis

JRCT ID: jRCTs031180346

Registered date:18/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: multiple sclerosis
• Date of first enrollment: 02/12/2013
• Target sample size: 6
• Study type: Interventional
• Intervention(s): Tocilizumab is to be infused every 4 weeks at 8 mg/kg of body weight.

Outcome(s)

Primary Outcome

- Adverse events after the initiation of TCZ
- 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) Serum and cerebral spinal fluid cytokine profiles
5) Plasmablast frequency and functional analysis of activation markers, antibody production, and proliferation
6) T cell subsets and the cytokine profiles
7) Gut microbiota

Key inclusion & exclusion criteria

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

Include criteria

A)Diagnosis as relapsing-remitting multiple sclerosis (RRMS) according to 2010 revised McDonald criteria (Ann Neurol 2011; 69: 292-302).
B)Intractable patients with RRMS resistant to standard therapies other than tocilizumab with more than two relapses or disability progression during the 1 year prior to initiation to this study.
C)With a higher plasmablast frequency in peripheral blood than the mean frequency + 2SD in healthy donors by flow cytometry.

Since a relapsing-remitting phase could turn out to be a secondary-progressive phase after the entry, the patients with secondary-progressive MS (SPMS) could be included in this study.

Exclude 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 < 3500/mm3), lymphopenia (lymphocyte number < 500/mm3) or seropositivity for beta-D-glucan in peripheral blood.
7) Patients with positivity for anti- aquaporin 4 antibody.
8) Pregnant women or patients with possible pregnancy.
9) Patients with a history of allergy to this drug
10) Patients who can not provide consent to participate in this study by themselves.

Related Information

• Primary Sponsor: Yamamura Takashi
• Source(s) of Monetary Support: Chugai Pharmaceutical Co. Ltd.,ational Center of Neurology and Psychiatry
• Secondary ID(s): UMIN000012705