An observational study in Multiple Sclerosis, NMO Spectrum Disorder and Clinically Isolated Syndrome, sponsored by Beijing Tiantan Hospital. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2023-07-21.
Sponsored by Beijing Tiantan Hospital · Observational
Among 59 studies in Multiple Sclerosis with a site in China — 31 open to participants now, 36 under way, 5 of them phase 3. Multiple Sclerosis · China.
Among the 59 studies in Multiple Sclerosis with a site in China, this one is the 2nd largest by planned enrollment of the 14 observational ones that give a count, is one of 4 that started in 2021, is one of 14 observational ones, reaches primary completion later than 6 of the 35 other live ones, and was the 17th registered.
3,264 studies on the registry are indexed under Multiple Sclerosis; 659 are open to participants now.
Browse Multiple Sclerosis studies →31 of the 59 studies in Multiple Sclerosis with a site in China are open now. Recruiting first, the newest first:
Chuan Qin · Sites in China
Guangzhou Lupeng Pharmaceutical Company LTD. · Sites in China
Xijing Hospital · Sites in China
Tongji Hospital · Sites in China
Daishi Tian · Sites in China
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 430 Multiple Sclerosis studies recruiting now, 163 (38%) set no upper age limit and 211 (49%) stop at 75 or younger; 40 take children under 18; 96 take healthy volunteers.
This study: all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
59 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 18 · Phase 2 6 · Phase 3 11 · Phase 4 5
First in 2006; this study’s year is marked. 4 started in 2021.
This study's planned enrollment of 10,000 is above the median of 100 across 970 observational studies indexed under Multiple Sclerosis.
Median enrollment 60 across the 45 interventional studies, 375 across the 14 observational. Of the 15 that completed or were terminated, 8 (53%) have results posted.
This tab as a report to print or save as PDF → With an account.
22 of 59 have an industry lead sponsor. The 10 most frequent:
Beijing Tiantan Hospital is the lead sponsor of 489 studies on the registry; 293 are open to participants now.
Beijing Tiantan Hospital has 3 studies filed under Multiple Sclerosis — fewer than ten, so there is no comparison to draw.
16 of the studies in Multiple Sclerosis with a site in China that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06141473Phase 3SanofiEfficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sclerosis | 2027-05-06 |
| NCT07325292Phase 3SanofiNon-inferiority Study of Frexalimab Subcutaneous Administration Compared to Intravenous Administration in Adult Participants With Multiple Sclerosis | 2027-07-15 |
| NCT07337785Tongji HospitalCD19/BCMA-Targeted UCAR-T for Patients With Neurological Autoimmune Diseases | 2026-12-01 |
| NCT07353216Third Affiliated Hospital, Sun Yat-Sen UniversityExploring the Efficacy and Safety of Ofatumumab in Patients With Relapsing Multiple Sclerosis (RMS) and Its Impact on Serum Neurofilament Light Chain (sNfL) Levels | 2026-12-01 |
| NCT06485232Xuanwu Hospital, BeijingUniversal CAR-T Cells in Patients with Refractory Autoimmune Diseases of the Nervous System. | 2026-12-31 |
Among the 59 studies in Multiple Sclerosis with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
10000 IDD patients are planned to be recruited from many sites throughout the country.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Diagnosis of MS and CIS based on the 2017 McDonald MS diagnostic criteria.
Drug: Intravenous steroid
Diagnosis of ADEM based on the 2012 IPMSSG diagnostic criteria for ADEM
Drug: Intravenous steroid
Diagnosis of MOGAD based on the 2020 Chinese Expert Consensus.
Drug: Intravenous steroid
diagnosis of NMOSD according to 2015 International Panel for Neuromyelitis Optica Diagnosis criteria.
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.
Also known as: Immunoglobulin, Immunosuppressive Drugs, Disease-Modifying Drugs
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.
Time frame: 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.
Time frame: baseline, Month 6, Month12, Month18, Month24, Month30, Month36, Month42, Month48, Month54, Month60
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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
Adjusted mean change in HCLA every year from baseline as determined by 100% high contrast Sloan letter charts, adjusted for the baseline HCLA value.
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
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.
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.
Adjusted mean percentage change in thickness of the RNFL every year for the affected eye from the baseline as determined by SD-OCT.
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.
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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: baseline, year1, year2, year3, year4, year5.
Started Dec 2021 (actual). Primary completion is estimated for Nov 2026, 58 months after the start.
Of 334 non-industry observational studies under Multiple Sclerosis, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 73. This study's planned 58 months is above that.
Counting every sponsor, half of 425 studies reached it within 41 months; a quarter within 15 and three quarters within 75.
How these figures are worked out, and which studies are left out of them.
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