Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 12:04 AM
NCT ID:
NCT04101058
Eligibility Criteria:
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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04101058
Study Brief:
Protocol Section:
NCT04101058