The purpose of this study is to initially observe the safety and effectivity of RC18 in Participants with Neuromyelitis Optica Spectrum Disorders.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
178
Starting with the forty-ninth dose,the trial went into the open phase. All participants were treated with the test drugs.
In the Phase B,the researchers can adjust the dose of RC18 according to the subjects' willingness and recurrence, but the maximum dose of single dose should not exceed 320g.
Beijing Hospital
Beijing, Beijing Municipality, China
Time to first relapse after randomization
Time frame: 144 weeks
Change from Baseline in Expanded Disability Status Scale (EDSS) Score at week 4,8,12,24,36,48,60,72,96,120,144
The EDSS is an ordinal clinical rating scale ranging from 0 (normal neurologic examination) to 10 (death) in half-point increments.
Time frame: 144 weeks
Change from Baseline in Hauser Ambulation Index at week 4,8,12,24,36,48,60,72,96,120,144
Time frame: week 4,8,12,24,36,48,60,72,96,120,144
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