An observational study in Multiple Sclerosis, sponsored by Third Affiliated Hospital, Sun Yat-Sen University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-20.
Sponsored by Third Affiliated Hospital, Sun Yat-Sen University · 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 13th largest by planned enrollment of the 14 observational ones that give a count, is one of 5 that started in 2023, is one of 14 observational ones, reaches primary completion later than 7 of the 35 other live ones, and was the 48th 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: 18 Years and older · 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. 5 started in 2023.
This study's planned enrollment of 80 is below 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:
Third Affiliated Hospital, Sun Yat-Sen University is the lead sponsor of 133 studies on the registry; 35 are open to participants now.
Third Affiliated Hospital, Sun Yat-Sen University 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.
Multiple sclerosis (MS) is an immune-mediated disease characterized primarily by inflammatory demyelinating lesions in the central nervous system (CNS), with the white matter being predominantly affected. Its etiology remains unclear and may be associated with various factors such as genetics, environment, and viral infections . Pathologically, MS presents as multiple demyelinating lesions in the CNS, which may be accompanied by damage to nerve cells and their axons. Lesions on MRI show characteristic distributions, morphologies, and signal intensities . MS typically onset in young adults and is more common in women. Frequent symptoms include visual decline, diplopia, limb sensory disturbances, limb motor impairment, ataxia, and bladder or rectal dysfunction . As MS can lead to varying degrees of neurological deficits, and repeated relapses result in disability progression, it impacts patients' normal lives and work, posing a significant burden on individuals, families, and society. Considerable progress has been made in MS treatment in recent years, with agents such as teriflunomide, fingolimod, siponimod, and dimethyl fumarate having been approved for marketing in China.
In the two concurrently conducted active-comparator trials, ASCLEPIOS I and II, involving patients with relapsing multiple sclerosis, the annualized relapse rate was significantly lower in the ofatumumab group compared to the teriflunomide group. Ofatumumab was also superior to teriflunomide in suppressing MRI lesion activity . Although the aforementioned studies have confirmed the clinical efficacy of ofatumumab in treating MS, data from Chinese populations are lacking. Its clinical effectiveness, safety, and optimal treatment timing require further support from real-world evidence.
Exploring more indicators to predict MS disease activity and progression is crucial for identifying high-risk patients, assessing prognosis, and evaluating treatment response. Neurofilament light chain (NfL) is a specific biomarker for neuroaxonal damage, released into the cerebrospinal fluid (CSF) and serum after axonal injury . Serum and CSF NfL concentrations are highly correlated. Numerous studies in recent years have shown that high sNfL levels are associated with active T2 lesions and relapses, as well as brain volume loss. sNfL can not only monitor disease activity and treatment response at the group level in MS patients but also predict disease course, making it a valuable biomarker for predicting MS relapses and disability progression. It helps identify patients at higher risk of future disease activity and assists in clinical decision-making. Previous data from ASCLEPIOS I and II demonstrated that ofatumumab significantly reduced sNfL concentrations at the first assessment (Month 3) and at all subsequent visits in patients with RMS . However, existing studies have not included data from Chinese populations. This study aims to address this data gap for this specific population.
gender unrestricted, aged at least 18 years, diagnosed with Relapsing Multiple Sclerosis (RMS)
Inclusion Criteria:Signed and dated must be obtained before participation in the study.
Any gender, aged at least 18 years at the time of study enrollment (signing the informed consent form).
Patients with RMS meeting the 2017 Revised McDonald Criteria. EDSS score between 0 and 7. Regular follow-up with MRI monitoring. Willingness to provide blood samples. Willingness to undergo clinical assessments (including scales and physical examinations).
-
Exclusion Criteria:Decision by the subject/legal guardian . Pregnancy. Diagnosis of Progressive Multifocal Leukoencephalopathy (PML). reaction to the drug. Protocol violation that poses a significant safety risk to the subject. Occurrence of certain adverse events, such as , hepatic failure, or severe chronic infections (e.g., active , ).
Any laboratory abnormality that, considering the subject's overall condition, is deemed to prevent the subject's continued participation in the study.
Any condition that may pose a safety risk due to participation in the study. Non-compliance with the administration of the investigational drug or study procedures
-
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.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
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.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ofatumumab 20mg
Ofatumumab treatment reduces sNfL levels in patients with Relapsing Multiple Sclerosis
Time frame: Evaluation timing includes from the baseline to 12 and 24 months after starting Ofatumumab treatment.
Plan to share: No
No publications or documents are linked to this record.
Started Dec 2023 (actual). Primary completion is estimated for Dec 2026, 36 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 36 months is close to 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.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Third Affiliated Hospital, Sun Yat-Sen University →