A Registered Cohort Study of Inflammatory Demyelination Disease

Demyelinating Autoimmune Diseases, CNS Clinical Trial

Official title:

A Registered Cohort Study on Natural Course and Drug Efficacy of Inflammatory Demyelination Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04386018
• Other study ID #: MRCTA,ECFAH of FMU [2019]216
• Status: Recruiting
• Start date: May 15, 2020
• Est. completion date: April 1, 2025

Study information

• Verified date: November 2020
• Source: First Affiliated Hospital of Fujian Medical University
• Contact: Jin Bi, BA
• Phone: 86-13673527355
• Email: 2311306109[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study will provide further insights into the natural course of Inflammatory demyelination disease including clinical features，progression, related antibody spectrum and drug treatment effect

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: April 1, 2025
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Outpatient or inpatient

2. Meet the diagnostic criteria of Inflammatory Demyelination Disease.

3. Voluntary participation and informed consent signed by the applicant or his/her family.

Exclusion Criteria:

1. Severe complications

2. Poor prognosis (<1 year survival)

3. Severe mental disorder and inability to cooperate with the examination.

Related Conditions & MeSH terms

• Autoimmune Diseases
• Demyelinating Autoimmune Diseases, CNS
• Demyelinating Diseases

Locations

Country	Name	City	State
China	Department of Neurology,First Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Ning Wang, MD., PhD.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The correlation between clinical phenotypes and Serum antibodies	Different clinical subtypes of Demyelinating Autoimmune Diseases have different course and prognosis.It may be related to different serum antibodies.	from date of enrollment until the date of death from any cause,assessed up to 20 years