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HomeResearch   Participate in Research Studies   Participate in a Clinical Trial

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Participate in a Clinical Trial

Without the participation of people with MS, it would be impossible to develop new and better therapies and other interventions.

Clinical Trial Finder

Search Results

China National Registry of Neuro-Inflammatory Diseases

Study Purpose

Central nervous system (CNS) idiopathic inflammatory demyelinating diseases (IDD) are mainly diseases caused by autoimmune factors that result in CNS demyelination damage and loss. It tends to accumulate in the brain, spinal cord and optic nerves. Multiple sclerosis (MS), clinically isolated syndrome (CIS), neuromyelitis optica spectrum disorder (NMOSD), myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD) and acute disseminated encephalomyelitis (ADEM) are all common IDDs of the CNS. Besides, primary angiitis of the central nervous system (PACNS), autoimmune glial fibrillary acidic protein astrocytopathy (GFAP-A), etc. may also be included because they are important differential diagnoses. This study will establish a large prospective cohort study database of Chinese IDD, which will record detailed electronic information on IDD patients, including demographic and socioeconomic data, medical history, clinical information, medication, and relevant examination results. The long-term observational study will be used to understand the natural history of disease, disability progression rates, imaging and biological indicators, long-term treatment approaches and prognosis of Chinese patients with IDD, to find predictive markers for IDD progression and prognosis, and to identify factors that influence the treatment and prognosis of patients with IDD.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages N/A and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 1.
No requirement for age and sex.
  • - 2.
Need to meet the diagnosis of at least one IDD (clinically isolated syndrome (CIS)/multiple sclerosis (MS)/neuromyelitis optica spectrum disorder (NMOSD)/MOG antibody-associated disease (MOGAD)/acute disseminated encephalomyelitis (ADEM).
  • - 3.
Signed informed consent form.

Exclusion Criteria:

  • - Those with severe mental disease unable to cooperate with the examination and/or follow-up.
  • - Any patient (or the patient's legal representative) who is unable or refuses to sign informed consent.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05154370
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Beijing Tiantan Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Sclerosis, NMO Spectrum Disorder, Clinically Isolated Syndrome, CNS Demyelinating Autoimmune Diseases, Acute Disseminated Encephalomyelitis, Primay Angiitis of the Central Nervous System, Autoimmune Glial Fibrillary Acidic Protein Astrocytopathy
Additional Details

Large prospective cohort studies allow long-term observation and analysis of the clinical status and disease activity of IDD patient population, and are the best way to understand IDD's natural course, clinical outcome, and drug efficacy in specific populations. Globally, several large prospective follow-up cohort studies have been conducted, providing important information on the disease characteristics of IDD patients. However, there is no large nationwide registry study of CNS IDD in China, and therefore there is a relative lack of data on the natural course of disease and drug efficacy in the Chinese IDD patient population, as well as a lack of standardized follow-up management of Chinese IDD patients. This study will establish a large prospective cohort study database of Chinese IDD, which will record detailed electronic information on IDD patients. We aim to establish a national (multicenter) disease registry for central nervous system idiopathic inflammatory demyelinating diseases in China, and to establish a unified standardized follow-up management process and treatment guidelines for patients with IDD in China; To provide real world data on the disease status of Chinese IDD patients; To understand the disease progression characteristics of IDD in China; To search for biological and imaging markers that predict the relapse, progression, and prognosis of IDD; to investigate the efficacy, safety, compliance and switch of different disease-modifying drugs (DMDs) in the long-term treatment of Chinese patients with IDD. The study is a prospective observational (non-interventional) national multicenter cohort study to collect clinical data from IDD patients who have signed informed consent, to routinely and regularly follow up IDD patients on multiple clinical indicators, and to assess clinical outcomes. All information is to be completed prospectively from the time point the patient visited the hospital (except for Basic patient information and information about previous disease that are required at enrollment follow-up).Once the project started, the study sites are not allowed to discontinue the study on their own until the end of study is announced. In addition, to ensure the continuity of the data, each site needs to appoint designated clinical data collectors to collect data from qualified inpatient clinical cases consecutively, so as to ensure the consecutive registration of each inpatient case who meets the inclusion and exclusion criteria. As the purpose of this study is to establish a national multicenter disease registry to provide disease-related information on patients with IDD in China, and the primary and secondary endpoints of the study being descriptive endpoints, therefore no formal calculation of sample size is needed. 10000 IDD patients are planned to be recruited.

Arms & Interventions

Arms

: MS/CIS

Diagnosis of MS and CIS based on the 2017 McDonald MS diagnostic criteria.

: ADEM

Diagnosis of ADEM based on the 2012 IPMSSG diagnostic criteria for ADEM

: MOGAD

Diagnosis of MOGAD based on the 2020 Chinese Expert Consensus.

: NMOSD

diagnosis of NMOSD according to 2015 International Panel for Neuromyelitis Optica Diagnosis criteria.

Interventions

Drug: - Intravenous steroid

This study does not limit treatment methods. Patients commonly use high-dose intravenous steroid therapy (HD-S) during acute stage. Immunomodulatory therapies are necessary for the remission stage. All drugs are used in accordance with relevant guidelines.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Beijing Tiantan Hospital, Beijing, Beijing, China

Status

Recruiting

Address

Beijing Tiantan Hospital

Beijing, Beijing, 100069

Site Contact

Fu-Dong Shi

[email protected]

15202282795

Nearest Location

Site Contact

Fu-Dong Shi

[email protected]

15202282795


Resources

Clinical Trials in MS


The latest clinical research in MS, including trials funded by the Society and trials in progressive MS.

Read more

Read more

NARCOMS Patient Registry

Register as a willing MS research participant to facilitate multicenter studies. Initiated by the Consortium of MS Centers.

Visit NARCOMS

Visit NARCOMS

Posting a Trial

If you would like us to post a study on these pages, please email [email protected] to find out what information you need to submit for review.

Powered By

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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