The efficacy and safety of an anti-interluekin-6 receptor antibody in relapsing-remitting multiple sclerosis
- Conditions
- Relapsing-remitting multiple sclerosis
- Registration Number
- JPRN-UMIN000012705
- Lead Sponsor
- Department of Immunology, National Institute of Neuroscience, NCNP
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 10
Not provided
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) Pregnant women or patients with possible pregnancy. 8) Patients with a history of allergy to this drug 9) Patients who can not provide consent to participate in this study by themselves.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method -Relapse rate, disability (EDSS), and MRI parameters up to 1 or 2 years. -Adverse events up to 1 or 2 years.
- Secondary Outcome Measures
Name Time Method