Rituximab for the Treatment of New-onset AChR-Myasthenia Gravis

NCT07071246 | Active Not Recruiting DMC

• 1 other identifier: 202206-13
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Treatment

Keywords

myasthenia gravis; rituximab; efficacy; safety

Outcome Measures

Primary Outcomes (3)

• 70% enrolled patients reached the minimum state (MM) or better state of MGFA - post intervention state (PIs) at 1 year after administration of study drug

  No functional impairment and some muscle weakness may be detected by a specialist neurologist

  12 months

• 80% enrolled patients reached the clinical complete remission (CSR) of MGFA - post intervention status (PIs) at 2 years after administration of study drug

  No signs and symptoms of muscle weakness for at least 1 year, no medical treatment for MG during this period, no evidence of muscle weakness after examination by a professional neurologist, mild eyelid closure weakness is allowed

  24 months

• Safety: The incidence of treatment-related adverse reactions and withdrawal because of serious adverse reaction

  Any adverse reaction, like fever, rash, dizziness and so on.

  through study completion

Secondary Outcomes (1)

• The proportion of patients with ocular myasthenia gravis (OMG) progressed to generalized myasthenia gravis (GMG).

  After 2 years of follow-up

Study Arms (1)

RTX intravenously for the treatment of myasthenia gravis

OTHER

RTX administrating 100mg per week consecutively for 3 weeks

Drug: Rituximab Injection

Interventions

Rituximab Injection DRUG

low dose of rituximab intravenously

Also known as: RTX

RTX intravenously for the treatment of myasthenia gravis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Myasthenic crisis at screening (MGFA grade V);
• Accompanied with serious physical diseases, such as severe heart failure;
• Liver and kidney insufficiency or elevated transaminases (AST/ALT elevation exceeds 2.5 times the upper limit of normal)
• 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;
• Use of immunosuppressive agents, including rituximab, azathioprine, mycophenolate mofetil, cyclophosphamide, mycophenolate mofetil, cyclosporine, tacrolimus or methotrexate, etc.;
• Potential acute or chronic viral or bacterial infection, such as HIV, latent hepatitis B, tuberculosis, etc.;
• Vaccination history within 4 weeks before enrollment;
• 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.

Sponsors & Collaborators

• Tang-Du Hospital: lead

Study Sites (1)

Tangdu Hospital, Fourth Military Medical University

Xi'an, Shaanxi, 710038, China

Location

Related Publications (26)

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MeSH Terms

Conditions

Myasthenia Gravis

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Neurodegenerative Diseases; Neuromuscular Junction Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2022
• First Posted: July 17, 2025
• Study Start: August 1, 2022
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)