Treatment Response Among Chinese Neuromyelitis Optica Spectrum Disorders
关键词
抽象
描述
Neuromyelitis Optica (NMO)/ Neuromyelitis Optica Spectrum Disorders (NMOSD) is an immune-mediated inflammatory demyelinating disease of the central nervous system mainly involving optic nerve and spinal cord. It is clinically characterized by simultaneous or sequential involvement of the optic nerve and spinal cord, presenting a progressive or remission and relapse course, which can lead to paralysis and blindness.
Globally, there is no solid data available for the diagnosis, treatment and prognosis of patients with acute Neuromyelitis Optica Spectrum Disorders (NMOSD) attack, particularly very rare data from prospective studies. This is a multicenter, prospective, real-world cohort study in patients with acute NMOSD attack in China.
Baseline data for approximately 200 patients with acute NMOSD attack from approximately 4 centers will be collected. Patients with acute NMOSD attack (including first episodes and relapses) whose expansile disability status score (EDSS ) ≥ 2 points at baseline will be eligible to be further included in prospective study cohort for analysis of treatment effects and prognosis.
The objective of this study is to provide evidence regarding treat effects and factors related to prognosis which will help physicians better evaluable risk-benefit in NMOSD management and improve patients' outcome.
日期
| 最后验证: | 09/30/2019 |
| 首次提交: | 12/13/2018 |
| 提交的预估入学人数: | 09/22/2019 |
| 首次发布: | 09/23/2019 |
| 上次提交的更新: | 10/14/2019 |
| 最近更新发布: | 10/16/2019 |
| 实际学习开始日期: | 01/20/2019 |
| 预计主要完成日期: | 01/01/2020 |
| 预计完成日期: | 06/29/2020 |
状况或疾病
相
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 取样方式 | Probability Sample |
| 接受健康志愿者 | 是 |
| 标准 | 1. Inclusion criteria for patients with baseline data collection: 1. The subject can fully understand the content of the study and voluntarily sign the informed consent form; 2. Male or female ≥18 years old; 3. Diagnosed as NMOSD based on 2015 NMOSD diagnostic criteria of International NMO Diagnostic Team (IPND) and currently under acute attack. 2. Inclusion criteria for subjects enrolled in a prospective study cohort should further meet: 1. The subject can fully understand the content of the study and voluntarily sign the informed consent form; 2. Male or female,≥18 years old; 3. Diagnosed as NMOSD based on 2015 NMOSD diagnostic criteria of International NMO Diagnostic Team (IPND) and currently under acute attack. 4. Subjects with acute attack (including first episodes and relapse) should have an EDSS of ≥ 2 at baseline; and for patients with acute relapse, new symptoms or the primary symptoms, being judged by investigator, should have been aggravated for 24 hours or more [11-13]; 5. The subject should have typical symptoms of movement, sensation, vision, defecation/urination or nausea/vomiting at attack; 6. Subjects should agree to participate in the study, and to receive AQP4-IgG examination before and after treatment; 7. Subjects should agree to undergo an ophthalmologic examination before and after treatment; 8. Subjects should agree to participate the study and agree to have the collected data analyzed by this study. 3. Exclusion criteria: 1. Subjects treated with study medication in another clinical trial during the last 30 days or 5 half-life periods prior to screening or during the effect period of the drug, whichever is the longest; Note: Subjects who participated in an observational study (ie, the study did not require changes to medication or other interventions) were not excluded. 2. Immediate relatives of the researcher/research center staff directly related to the study, or the researcher/research center staff directly related to the study ("immediate relatives" refer to spouses, parents, children or siblings (Whether it's biological or legal adoption). |
结果
主要结果指标
1. Expansile Disability Status Score [at the end of the first high-dose intravenous Methylprednisone (IVMP) therapy (up to 3 weeks )among subjects who received high-dose IVMP]
次要成果指标
1. Expansile Disability Status Score [at discharge (7 days after last treatment)]
2. Changes In AQP4-IgG [at the end of the first IVMP therapy（up to 3 weeks) among subjects who received high-dose IVMP]
3. As Assessed By Snellen Chart [at the end of the first high-dose IVMP theraty (up to 3 weeks) among subjects who received high-dose IVMP]
4. PGI-I Score [at the end of the first high-dose IVMP therapy(up to 3 weeks) among subjects who received high-dose IVMP]
5. Changes In AQP4-IgG [at discharge (7 days after the last treatment)]
6. As Assessed By Snellen Chart [at discharge (7 days after the last treatment)]
7. PGI-I Score [at discharge (7 days after the last treatment)]
8. Expansile Disability Status Score [at discharge (7 days after the last treatment)]
9. The proportion of patients who did not respond to the first high-dose IVMP therapy(up to 3 weeks) [at discharge (7 days after the last treatment)]
