Status:
UNKNOWN
Treatment Response Among Chinese Neuromyelitis Optica Spectrum Disorders
Lead Sponsor:
Third Affiliated Hospital, Sun Yat-Sen University
Collaborating Sponsors:
Nanfang Hospital, Southern Medical University
Second Affiliated Hospital of Guangzhou Medical University
Conditions:
Neuromyelitis Optica Spectrum Disorders
Eligibility:
All Genders
18+ years
Brief Summary
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 spin...
Detailed Description
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 spin...
Eligibility Criteria
Inclusion
- 1\. Inclusion criteria for patients with baseline data collection:
- The subject can fully understand the content of the study and voluntarily sign the informed consent form;
- Male or female ≥18 years old;
- 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:
- The subject can fully understand the content of the study and voluntarily sign the informed consent form;
- Male or female,≥18 years old;
- Diagnosed as NMOSD based on 2015 NMOSD diagnostic criteria of International NMO Diagnostic Team (IPND) and currently under acute attack.
- 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 \[11-13\];
- The subject should have typical symptoms of movement, sensation, vision, defecation/urination or nausea/vomiting at attack;
- Subjects should agree to participate in the study, and to receive AQP4-IgG examination before and after treatment;
- Subjects should agree to undergo an ophthalmologic examination before and after treatment;
- Subjects should agree to participate the study and agree to have the collected data analyzed by this study.
- 3\. Exclusion criteria:
- 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.
- 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).
Exclusion
Key Trial Info
Start Date :
January 21 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2020
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04101058
Start Date
January 21 2019
End Date
June 30 2020
Last Update
October 17 2019
Active Locations (1)
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1
Wei Qiu
Guangzhou, China