Demyelinating Autoimmune Diseases, CNSNCT04386018
A Registered Cohort Study of Inflammatory Demyelination Disease
An observational study of Demyelinating Autoimmune Diseases, CNS, run by Ning Wang, MD., PhD. at 1 site in China.
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 Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Demyelinating Autoimmune Diseases, CNS
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2020to 1 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients with Inflammatory Demyelination Disease who are diagnosied in the First Affiliated Hospital of Fujian Medical Universtiy by two neurolgists
Who may be able to join
- Outpatient or inpatient
- Meet the diagnostic criteria of Inflammatory Demyelination Disease.
- Voluntary participation and informed consent signed by the applicant or his/her family.
Who cannot join
- Severe complications
- Poor prognosis (<1 year survival)
- Severe mental disorder and inability to cooperate with the examination.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Neurology,First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005
Wang Ning, PhD, 86-0591-87982772, ningwang@fjmu.edu.cn
Aiyu Lin, PhD
About this study
Official title: 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
- Conditions
- Demyelinating Autoimmune Diseases, CNS
- Medical subject headings
- Demyelinating Autoimmune Diseases, CNS
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from date of enrollment until the date of death from any cause,assessed up to 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start15 May 2020
- Primary completion1 Apr 2022 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Demyelinating Autoimmune Diseases, CNSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ning Wang, MD., PhD.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ning Wang, MD., PhD., First Affiliated Hospital of Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04386018
- Sponsor's protocol ID
- MRCTA,ECFAH of FMU [2019]216
- Status last verified
- Nov 2020
- First submitted
- 10 May 2020
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Registered Cohort Study on Natural Course and Drug Efficacy of Inflammatory Demyelination Disease
- ClinicalTrials.gov ID
- NCT04386018
- Acronym / sponsor ID
- MRCTA,ECFAH of FMU [2019]216
- Conditions
- Demyelinating Autoimmune Diseases, CNS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Ning Wang, MD., PhD.University, hospital or other
- Study start
- 15 May 2020 (actual)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 13 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with Inflammatory Demyelination Disease who are diagnosied in the First Affiliated Hospital of Fujian Medical Universtiy by two neurolgists
Key inclusion criteria (3 listed)
- Outpatient or inpatient
- Meet the diagnostic criteria of Inflammatory Demyelination Disease.
- Voluntary participation and informed consent signed by the applicant or his/her family.
Key exclusion criteria (3 listed)
- Severe complications
- Poor prognosis (<1 year survival)
- Severe mental disorder and inability to cooperate with the examination.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Demyelinating Autoimmune Diseases, CNS, run by Ning Wang, MD., PhD. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jin Bi, BA (86-13673527355, 2311306109@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2020.