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Sponsor Strategic Priority Adjustment
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The purpose of this study is to initially observe the safety and effectivity of RC18 in Participants with Neuromyelitis Optica Spectrum Disorders.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Comparator | Experimental | Participants received placebo weekly administered subcutaneously for 48 times in the double-blind treatment period.Once the participants relapse,they should advance to the open phase.All participants were treated with the test drugs. |
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| RC18 160 mg | Experimental | Patients received the test group RC18 160mg weekly administered subcutaneously for 48 times.Starting with the forty-ninth dose,the trial went into the open phase . All participants were treated with the test drugs. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Biological | Starting with the forty-ninth dose,the trial went into the open phase. All participants were treated with the test drugs. |
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| Measure | Description | Time Frame |
|---|---|---|
| Time to first relapse after randomization | 144 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 144 weeks |
| Change from Baseline in Hauser Ambulation Index at week 4,8,12,24,36,48,60,72,96,120,144 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| xianhao Xu | Beijing Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Hospital | Beijing | Beijing Municipality | China |
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| ID | Term |
|---|---|
| D009471 | Neuromyelitis Optica |
| ID | Term |
|---|---|
| D009188 | Myelitis, Transverse |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C035529 | RC-18 |
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| RC18 160 mg | Biological | 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. |
|
| week 4,8,12,24,36,48,60,72,96,120,144 |
| D009902 | Optic Neuritis |
| D009901 | Optic Nerve Diseases |
| D003389 | Cranial Nerve Diseases |
| D003711 | Demyelinating Diseases |
| D005128 | Eye Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |