NCT07071246Active, not recruiting
Rituximab for the Treatment of New-onset AChR-Myasthenia Gravis
Source: ClinicalTrials.gov · Last updated 17 Jul 2025
Brief summary (registry, in English)
Myasthenia gravis (MG) is the most common acquired disorder of neuromuscular junction (NMJ), the most common antibody (in 85% MG patients) being the nicotinic acetylcholine receptor (AChR). Traditional medical treatments of new-onset MG include anticholinesterase inhibitors, immunomodulating therapies such as intravenous immunoglobulin (IVIG) and plasma exchange (PLEX) and immunosuppressive agents such as corticosteroids, azathioprine, mycophenolate mofetil, cyclosporine, methotrexate and cyclophosphamide. Since a status of complete stable remission (CSR, defined as remission of MG without pharmacological treatment≥1 year) is difficult to achieve, the international consensus guidance for management of MG proposed "minimal manifestation (MM) or better status" with no greater than mild adverse events as a practical goal of MG treatment. Given the balance between efficacy and safety, a more aggressive strategy and approach for immune therapies are critical in early stage of new-onset MG. In clinical practice, biological agent monoclonal antibody rituximab (RTX), specifically targeting B-lymphocyte differentiation membrane antigen CD20, has been increasing in recent years for some immune-mediated neurological diseases such as multiple sclerosis (MS) and neuromyelitis optica spectrum disorders (NMOSD), and gradually represented potential advantages in immunosuppressive therapy-refractory and new-onset AChR-MG. However, up to now, the individualized regimen, optimal dosage and clinical benefit of RTX monotherapy for early stage of new-onset AChR-MG still need to be elucidated. This study was performed to assess the long-term clinical efficacy and safety of individualized low-dose 100 mg RTX monotherapy approach in new-onset AChR-MG patients.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 12 Jul 2022
- Start date
- 1 Aug 2022
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Tang-Du Hospital
- Diseases
- Myasthenia gravis
- NCT number
- NCT07071246
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 1 Aug 2022 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Vaccination history within 4 weeks before enrollment;
Other illness
- Accompanied with serious physical diseases, such as severe heart failure;
- Suffering from clinical depression symptoms and serious mental illness;
- Combined with other neurological diseases, with a history of organic brain diseases and traumatic brain injury;
- Potential acute or chronic viral or bacterial infection, such as HIV, latent hepatitis B, tuberculosis, etc.;
Lab values
- Liver and kidney insufficiency or elevated transaminases (AST/ALT elevation exceeds 2.5 times the upper limit of normal)
Other
- Myasthenic crisis at screening (MGFA grade V);
- Use of immunosuppressive agents, including rituximab, azathioprine, mycophenolate mofetil, cyclophosphamide, mycophenolate mofetil, cyclosporine, tacrolimus or methotrexate, etc.;
- During pregnancy or breastfeeding;
- Those who cannot sign the informed consent;
- Patients with poor compliance;
- Any other situation in which the investigator believes that the patient should not participate in this trial.
Who the study is looking for
- The patients signed the informed consent form, and the subjects were willing to complete the research protocol as planned;
- The age is over 18 years old, and the gender is not limited (women of childbearing age have a negative pregnancy test);
- Meet the diagnostic criteria of the Chinese Guidelines for the Diagnosis and Treatment of Myasthenia Gravis (2020 Edition);
- The subjects of the study are all Chinese Han people;
- Good physical condition;
- Complete demographic and clinical data during the baseline survey and follow-up;
- Serum AChR antibody positive;
- New-onset AChR-MG, with symptoms no more than 12 months;
- American Myasthenia Gravis Foundation (MGFA) clinical classification grades I to IV (grade I only indicates ocular muscle weakness, grade II mild systemic disease, grade III moderate systemic disease, grade IV severe systemic disease , Grade V requires intubation crisis);
- The patient has never received immunosuppressive therapy or RTX therapy. If receiving cortisol hormone therapy, the oral dose should be less than 3 months, and the daily dose should not exceed 40 mg.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tangdu Hospital, Fourth Military Medical University Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.