Multiple SclerosisCNRIDNCT05154370
China National Registry of Neuro-Inflammatory Diseases
An observational study of Multiple Sclerosis and NMO Spectrum Disorder, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multiple Sclerosis, NMO Spectrum Disorder, Clinically Isolated Syndrome
- What is being tested?
- Intravenous steroid
- Type of treatment
- Injection or infusion
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 15 Dec 2021to 1 Nov 2026
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: 10000 IDD patients are planned to be recruited from many sites throughout the country.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100069
Fu-Dong Shi, 15202282795, fshi@tmu.edu.cn
De-cai Tian, +18519703162, decaitian@163.com
About this study
Official title: China National Registry of Neuro-Inflammatory Diseases: a Prospective Cohort Study
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.
Read the detailed description
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.
- Conditions
- Multiple Sclerosis, NMO Spectrum Disorder, Clinically Isolated Syndrome, CNS Demyelinating Autoimmune Diseases, Acute Disseminated Encephalomyelitis, Primay Angiitis of the Central Nervous System
- Being tested
- Intravenous steroid
- Medical subject headings
- Multiple Sclerosis, Neuromyelitis Optica, Demyelinating Autoimmune Diseases, CNS, Encephalomyelitis, Acute Disseminated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous steroidDrug
Also called Immunoglobulin, Immunosuppressive Drugs, Disease-Modifying Drugs
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.
| Study group | Role | What they receive |
|---|---|---|
| MS/CIS | Diagnosis of MS and CIS based on the 2017 McDonald MS diagnostic criteria. Receives: Drug: Intravenous steroid | |
| ADEM | Diagnosis of ADEM based on the 2012 IPMSSG diagnostic criteria for ADEM Receives: Drug: Intravenous steroid | |
| MOGAD | Diagnosis of MOGAD based on the 2020 Chinese Expert Consensus. Receives: Drug: Intravenous steroid | |
| NMOSD | diagnosis of NMOSD according to 2015 International Panel for Neuromyelitis Optica Diagnosis criteria. Receives: Drug: Intravenous steroid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annual relapse rate (ARR) between baseline and follow-up in patients with IDD
a new neurological worsening lasting for at least 24 hours and occurring more than 30 days after the previous attack.
Measured: baseline up to 5 years
Change in EDSS scores of patients with IDD between baseline and follow-up over time
The Expanded Disability Status Scale (EDSS) is a rating system that is frequently used for classifying and standardizing the severity and progression. EDSS ranges from 0 to 10. The higher the score, the worse the clinical symptoms.
Measured: baseline, Month 6, Month12, Month18, Month24, Month30, Month36, Month42, Month48, Month54, Month60
Secondary outcomes (12)
The brain structural change over time between the baseline MRI and the follow-up MRIs
To describe changes of lesions, grey matter and white matter in patients with neuroinflammatory and demyelination disease measured by Brain Magnetic Resonance Imaging (MRI). The MRI sequence includes T2W_TRA、DWI、3DT1W_TFE_SAG、fMRI_EPI_TRA、mb2DKI_iso48_b1k2k_TRA、3DFLAIR_TSE_SAG、3DpCASL_GRASE_TRA、3DDIR_SAG、3DT2W_TSE、SWI_QSM_TRA. The secondary endpoint is the change over time between the baseline MRI and the follow-up MRIs, of the lesions and brain volumes.
Measured: baseline, year1, year2, year3, year4, year5.
The spinal cord change over time between the baseline MRI and the follow-up MRIs.
To describe changes of lesions and integrity of fiber bundle in spinal cord in neuroinflammatory and demyelination disease patients measured by MRI. The primary endpoint is the change over time between the baseline MRI and the follow-up MRIs, of structural change in spinal cord.
Measured: baseline, year1, year2, year3, year4, year5.
Change of the central vein sign at 7T MRI.
The central vein sign has been proposed as a specific imaging biomarker for distinguishing between multiple sclerosis (MS) and not MS.
Measured: baseline, year1, year2, year3, year4, year5.
Change of rim of iron at 7T MRI.
multiple sclerosis white matter lesions surrounded by a rim of iron containing microglia, termed iron rim lesions, signify patients with more severe disease course and a propensity to develop progressive multiple sclerosis.
Measured: baseline, year1, year2, year3, year4, year5.
Change in High-contrast Letter Acuity (HCLA) over time at baseline and during follow-up in patients with IDD
Adjusted mean change in HCLA every year from baseline as determined by 100% high contrast Sloan letter charts, adjusted for the baseline HCLA value.
Measured: baseline, year1, year2, year3, year4, year5.
Change in Low-contrast Letter Acuity (LCLA) over time at baseline and during follow-up in patients with IDD
Adjusted mean change in LCLA at baseline and every year as determined by 2.5% low contrast Sloan letter charts，adjusted for the baseline LCLA value.
Measured: baseline, year1, year2, year3, year4, year5.
Percentage Change in Spectral-domain Optical Coherence Tomography (SD-OCT) Average Retinal Nerve Fiber Layer (RNFL) Thickness at baseline and every year.
Adjusted mean percentage change in thickness of the RNFL every year for the affected eye from the baseline as determined by SD-OCT.
Measured: baseline, year1, year2, year3, year4, year5.
Percentage change in SD-OCT Average Retinal Ganglion Cell Layer/Inner Plexiform Retinal Layer (RGCL/IPL) every year.
Adjusted mean change in thicknesses of the RGCL/IPL every year for the affected eye from the baseline as determined by segmentation of SD-OCT.
Measured: baseline, year1, year2, year3, year4, year5.
Changes in cognitive function of patients with IDD at baseline and over time during follow-up
Scale assessment mainly rely on SDMT(Symbol Digit Modalities Test), MoCA( Montreal Cognitive Assessment), MMSE(Mini-mental State Examination) and so on. The Symbol Digit Modalities Test (SDMT) is widely used because it is easy to administer, reliable and also evaluates information processing speed. The Montreal Cognitive Assessment (MoCA) is a brief, 30-question test that helps healthcare professionals detect cognitive impairments very early on, allowing for faster diagnosis and patient care. The Mini-Mental State Exam (MMSE) is a widely used test of cognitive function among the elderly; it includes tests of orientation, attention, memory, language and visual-spatial skills.
Measured: baseline, year1, year2, year3, year4, year5.
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Treatment-emergent adverse events, treatment-emergent serious adverse events (TESAEs), including laboratory measurements as well as their changes or shift from baseline over time
Measured: From baseline to 5 years
NF-L level in serum.
Neurofilament light (NF-L) is a 68 kDa cytoskeletal intermediate filament protein that is expressed in neurons. Elevated blood concentrations of neurofilament light chain (NfL) were found to correlate with an increase in the number of relapses, disability worsening, MRI disease activity, and brain volume loss in MS.
Measured: baseline, year1, year2, year3, year4, year5.
Determination of serum autoimmune antibodies
Compare serum AQP4(Aquaporin 4)-ab titers, MOG(Myelin Oligodendrocyte Glycoprotein)-ab titers, MBP(myelin basic protein)-ab titers at baseline and every year.
Measured: baseline, year1, year2, year3, year4, year5.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2021
- Study start15 Dec 2021
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- 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
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05154370
- Sponsor's protocol ID
- KY2021-150-01
- Acronym
- CNRID
- Status last verified
- Jul 2023
- First submitted
- 8 Nov 2021
- Last updated
- 21 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
Publications
Xu Y, Meng H, Fan M, Yin L, Sun J, Yao Y, Wei Y, Cong H, Wang H, Song T, Yang CS, Feng J, Shi FD, Zhang X, Tian DC. A Simple Score (MOG-AR) to Identify Individuals at High Risk of Relapse After MOGAD Attack. Neurol Neuroimmunol Neuroinflamm. 2024 Nov;11(6):e200309. doi: 10.1212/NXI.0000000000200309. Epub 2024 Sep 9.
PubMed 39250723Jing J, Zhang Z, Su L, Gao C, Guo A, Liu X, Wang H, Zhang X, Liu Y, Comi G, Waubant E, Shi FD, Tian DC. Central vein sign and trigeminal lesions of multiple sclerosis visualised by 7T MRI. J Neurol Neurosurg Psychiatry. 2024 Jul 15;95(8):761-766. doi: 10.1136/jnnp-2023-332566.
PubMed 38453475
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- China National Registry of Neuro-Inflammatory Diseases: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05154370
- Acronym / sponsor ID
- CNRID / KY2021-150-01
- Conditions
- Multiple Sclerosis, NMO Spectrum Disorder, Clinically Isolated Syndrome, CNS Demyelinating Autoimmune Diseases, Acute Disseminated Encephalomyelitis, Primay Angiitis of the Central Nervous System
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 13 Dec 2021 (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.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MS/CIS | – | Drug: Intravenous steroidDiagnosis of MS and CIS based on the 2017 McDonald MS diagnostic criteria. |
| ADEM | – | Drug: Intravenous steroidDiagnosis of ADEM based on the 2012 IPMSSG diagnostic criteria for ADEM |
| MOGAD | – | Drug: Intravenous steroidDiagnosis of MOGAD based on the 2020 Chinese Expert Consensus. |
| NMOSD | – | Drug: Intravenous steroiddiagnosis of NMOSD according to 2015 International Panel for Neuromyelitis Optica Diagnosis criteria. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 10000 IDD patients are planned to be recruited from many sites throughout the country.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous steroidAlso: Immunoglobulin, Immunosuppressive Drugs, Disease-Modifying DrugsThis 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. | Drug | ADEM, MOGAD, MS/CIS, NMOSD |
Primary outcome
Annual relapse rate (ARR) between baseline and follow-up in patients with IDD
Time frame: baseline up to 5 years
a new neurological worsening lasting for at least 24 hours and occurring more than 30 days after the previous attack.
Change in EDSS scores of patients with IDD between baseline and follow-up over time
Time frame: baseline, Month 6, Month12, Month18, Month24, Month30, Month36, Month42, Month48, Month54, Month60
The Expanded Disability Status Scale (EDSS) is a rating system that is frequently used for classifying and standardizing the severity and progression. EDSS ranges from 0 to 10. The higher the score, the worse the clinical symptoms.
12 secondary outcomes
The brain structural change over time between the baseline MRI and the follow-up MRIs
Time frame: baseline, year1, year2, year3, year4, year5.
The spinal cord change over time between the baseline MRI and the follow-up MRIs.
Time frame: baseline, year1, year2, year3, year4, year5.
Change of the central vein sign at 7T MRI.
Time frame: baseline, year1, year2, year3, year4, year5.
Change of rim of iron at 7T MRI.
Time frame: baseline, year1, year2, year3, year4, year5.
Change in High-contrast Letter Acuity (HCLA) over time at baseline and during follow-up in patients with IDD
Time frame: baseline, year1, year2, year3, year4, year5.
Change in Low-contrast Letter Acuity (LCLA) over time at baseline and during follow-up in patients with IDD
Time frame: baseline, year1, year2, year3, year4, year5.
Percentage Change in Spectral-domain Optical Coherence Tomography (SD-OCT) Average Retinal Nerve Fiber Layer (RNFL) Thickness at baseline and every year.
Time frame: baseline, year1, year2, year3, year4, year5.
Percentage change in SD-OCT Average Retinal Ganglion Cell Layer/Inner Plexiform Retinal Layer (RGCL/IPL) every year.
Time frame: baseline, year1, year2, year3, year4, year5.
Changes in cognitive function of patients with IDD at baseline and over time during follow-up
Time frame: baseline, year1, year2, year3, year4, year5.
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: From baseline to 5 years
NF-L level in serum.
Time frame: baseline, year1, year2, year3, year4, year5.
Determination of serum autoimmune antibodies
Time frame: baseline, year1, year2, year3, year4, year5.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2023.
- Derived from this study: PubMed 39250723Xu Y, Meng H, Fan M, Yin L, Sun J, Yao Y, Wei Y, Cong H, Wang H, Song T, Yang CS, Feng J, Shi FD, Zhang X, Tian DC. A Simple Score (MOG-AR) to Identify Individuals at High Risk of Relapse After MOGAD Attack. Neurol Neuroimmunol Neuroinflamm. 2024 Nov;11(6):e200309. doi: 10.1212/NXI.0000000000200309. Epub 2024 Sep 9.
- Derived from this study: PubMed 38453475Jing J, Zhang Z, Su L, Gao C, Guo A, Liu X, Wang H, Zhang X, Liu Y, Comi G, Waubant E, Shi FD, Tian DC. Central vein sign and trigeminal lesions of multiple sclerosis visualised by 7T MRI. J Neurol Neurosurg Psychiatry. 2024 Jul 15;95(8):761-766. doi: 10.1136/jnnp-2023-332566.
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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 Multiple Sclerosis and NMO Spectrum Disorder, run by Beijing Tiantan Hospital 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 2 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 21 Jul 2023. 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 Fu-Dong Shi (8610-59976585, fshi@tmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Annual relapse rate (ARR) between baseline and follow-up in patients with IDD (time frame: baseline up to 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05154370, which also lists 2 linked publications.
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 21 Jul 2023.