A Registered Cohort Study of Inflammatory Demyelination Disease

November 11, 2020 updated by: Ning Wang, MD., PhD.

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

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

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350005
        • Recruiting
        • Department of Neurology,First Affiliated Hospital of Fujian Medical University
        • Principal Investigator:
          • Aiyu Lin, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The correlation between clinical phenotypes and Serum antibodies
Time Frame: from date of enrollment until the date of death from any cause,assessed up to 20 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ning Wang, MD., PhD.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 15, 2020

Primary Completion (ANTICIPATED)

April 1, 2022

Study Completion (ANTICIPATED)

April 1, 2025

Study Registration Dates

First Submitted

May 10, 2020

First Submitted That Met QC Criteria

May 10, 2020

First Posted (ACTUAL)

May 13, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 13, 2020

Last Update Submitted That Met QC Criteria

November 11, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRCTA,ECFAH of FMU [2019]216

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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