NCT04386018

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 13, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

May 15, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

November 13, 2020

Status Verified

November 1, 2020

Enrollment Period

1.9 years

First QC Date

May 10, 2020

Last Update Submit

November 11, 2020

Conditions

Demyelinating Autoimmune Diseases, CNS

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with Inflammatory Demyelination Disease who are diagnosied in the First Affiliated Hospital of Fujian Medical Universtiy by two neurolgists

You may qualify if:

  • Outpatient or inpatient
  • Meet the diagnostic criteria of Inflammatory Demyelination Disease.
  • Voluntary participation and informed consent signed by the applicant or his/her family.

You may not qualify if:

  • Severe complications
  • Poor prognosis (\<1 year survival)
  • Severe mental disorder and inability to cooperate with the examination.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurology,First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350005, China

RECRUITING

MeSH Terms

Conditions

Demyelinating Autoimmune Diseases, CNS

Condition Hierarchy (Ancestors)

Autoimmune Diseases of the Nervous SystemNervous System DiseasesLeukoencephalopathiesBrain DiseasesCentral Nervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Jin Bi, BA

CONTACT

86-136735273552311306109@qq.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

May 10, 2020

First Posted

May 13, 2020

Study Start

May 15, 2020

Primary Completion

April 1, 2022

Study Completion

April 1, 2025

Last Updated

November 13, 2020

Record last verified: 2020-11

Locations

CN(1)