TreatmentNCT07071246
Rituximab for the Treatment of New-onset AChR-Myasthenia Gravis
A study testing Rituximab Injection in people with Treatment, run by Tang-Du Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Treatment
- What is being tested?
- Rituximab Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2022to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Show all 10Show fewer
- 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.
Who cannot join
- 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.;
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Tangdu Hospital, Fourth Military Medical University
Xi'an, Shaanxi, 710038
About this study
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.
Read the detailed description
Myasthenia gravis (MG) is the most common acquired disorder of neuromuscular junction (NMJ), in which pathogenic autoantibodies bind to components of the postsynaptic membrane in NMJ, the most common antibody (in 85% MG patients) being the nicotinic acetylcholine receptor (AChR), followed by muscle-specific kinase (MuSK) or lipoprotein related peptide 4 (LRP4), thereby making impairment of neuromuscular transmission, causing fatigable weakness and even representing a potentially life-threatening condition. Traditional medical treatments of new-onset MG include anticholinesterase inhibitors such as pyridostigmine for temporarily symptomatic relief, immunomodulating therapies such as intravenous immunoglobulin (IVIG) and plasma exchange (PLEX) for a rapid but short-term clinical response, and immunosuppressive agents such as corticosteroids, azathioprine, mycophenolate mofetil, cyclosporine, methotrexate and cyclophosphamide for long-term treatment. Moreover, accompanied with prolonged duration, approximately 20% of the generalized MG population develop to refractory progressive course even with long-time and sufficient traditional immunosuppressive agents. For all newly diagnosed MG patients, chest computed tomography (CT) scan must be performed to assess for thymoma, and thymectomy should be done immediately in those thymoma patients with IVIG or PLEX treatment 1 to 2 weeks prior to thymectomy for optimizing condition, then followed by additional medical therapy for a sustained disease control. 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. AChR-MG is an archetype for B cell-mediated autoimmune disorder, clearly implicating a principal role for B cells in the disease pathogenesis. Therefore, B lymphocytes have always been the focus of investigative interests, especially with the successful introduction of biological therapeutics that target these cells. 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, using MG Foundation of America (MGFA)-Postintervention Status (PIS) "Minimal Manifestation (MM) or better status" as the primary outcome, changes in Quantitative Myasthenia Gravis (QMG), Manual Muscle Testing (MMT), MG-Related Activities of Daily Living (MG-ADL), and 15-item Quality-of-Life (MGQOL-15) scores as the secondary outcomes, as well as cholinesterase inhibitors reduction, peripheral CD19+B-cell percentage, AChR antibody titers and adverse effects.
- Conditions
- Treatment
- Being tested
- Rituximab Injection
- Keywords
- myasthenia gravis, rituximab, efficacy, safety
- Medical subject headings
- Myasthenia Gravis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rituximab InjectionDrug
Also called RTX
low dose of rituximab intravenously
| Study group | Role | What they receive |
|---|---|---|
| RTX intravenously for the treatment of myasthenia gravis | Other | RTX administrating 100mg per week consecutively for 3 weeks Receives: Drug: Rituximab Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: through study completion
Secondary outcomes (1)
The proportion of patients with ocular myasthenia gravis (OMG) progressed to generalized myasthenia gravis (GMG).
OMG progressed to the GMG at 2 years after treatment of study drug.
Measured: After 2 years of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start1 Aug 2022
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for TreatmentStudies of the same condition, open and under way.
- More trials run by Tang-Du 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07071246
- Sponsor's protocol ID
- 202206-13
- Status last verified
- Jul 2025
- First submitted
- 12 Jul 2022
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gilhus NE. Myasthenia Gravis. N Engl J Med. 2016 Dec 29;375(26):2570-2581. doi: 10.1056/NEJMra1602678. No abstract available.
PubMed 28029925Morren J, Li Y. Maintenance immunosuppression in myasthenia gravis, an update. J Neurol Sci. 2020 Mar 15;410:116648. doi: 10.1016/j.jns.2019.116648. Epub 2019 Dec 26.
PubMed 31901719Rath J, Brunner I, Tomschik M, Zulehner G, Hilger E, Krenn M, Paul A, Cetin H, Zimprich F. Frequency and clinical features of treatment-refractory myasthenia gravis. J Neurol. 2020 Apr;267(4):1004-1011. doi: 10.1007/s00415-019-09667-5. Epub 2019 Dec 11.
PubMed 31828474Mantegazza R, Antozzi C. From Traditional to Targeted Immunotherapy in Myasthenia Gravis: Prospects for Research. Front Neurol. 2020 Sep 2;11:981. doi: 10.3389/fneur.2020.00981. eCollection 2020.
PubMed 32982957Sanders DB, Wolfe GI, Benatar M, Evoli A, Gilhus NE, Illa I, Kuntz N, Massey JM, Melms A, Murai H, Nicolle M, Palace J, Richman DP, Verschuuren J, Narayanaswami P. International consensus guidance for management of myasthenia gravis: Executive summary. Neurology. 2016 Jul 26;87(4):419-25. doi: 10.1212/WNL.0000000000002790. Epub 2016 Jun 29.
PubMed 27358333Jaretzki A 3rd, Barohn RJ, Ernstoff RM, Kaminski HJ, Keesey JC, Penn AS, Sanders DB. Myasthenia gravis: recommendations for clinical research standards. Task Force of the Medical Scientific Advisory Board of the Myasthenia Gravis Foundation of America. Neurology. 2000 Jul 12;55(1):16-23. doi: 10.1212/wnl.55.1.16. No abstract available.
PubMed 10891897Brauner S, Eriksson-Dufva A, Hietala MA, Frisell T, Press R, Piehl F. Comparison Between Rituximab Treatment for New-Onset Generalized Myasthenia Gravis and Refractory Generalized Myasthenia Gravis. JAMA Neurol. 2020 Aug 1;77(8):974-981. doi: 10.1001/jamaneurol.2020.0851.
PubMed 32364568Di Stefano V, Lupica A, Rispoli MG, Di Muzio A, Brighina F, Rodolico C. Rituximab in AChR subtype of myasthenia gravis: systematic review. J Neurol Neurosurg Psychiatry. 2020 Apr;91(4):392-395. doi: 10.1136/jnnp-2019-322606. Epub 2020 Feb 25.
PubMed 32098874Punga AR, Maddison P, Heckmann JM, Guptill JT, Evoli A. Epidemiology, diagnostics, and biomarkers of autoimmune neuromuscular junction disorders. Lancet Neurol. 2022 Feb;21(2):176-188. doi: 10.1016/S1474-4422(21)00297-0.
PubMed 35065040Huijbers MG, Marx A, Plomp JJ, Le Panse R, Phillips WD. Advances in the understanding of disease mechanisms of autoimmune neuromuscular junction disorders. Lancet Neurol. 2022 Feb;21(2):163-175. doi: 10.1016/S1474-4422(21)00357-4.
PubMed 35065039Uzawa A, Kuwabara S, Suzuki S, Imai T, Murai H, Ozawa Y, Yasuda M, Nagane Y, Utsugisawa K. Roles of cytokines and T cells in the pathogenesis of myasthenia gravis. Clin Exp Immunol. 2021 Mar;203(3):366-374. doi: 10.1111/cei.13546. Epub 2020 Dec 3.
PubMed 33184844Villegas JA, Bayer AC, Ider K, Bismuth J, Truffault F, Roussin R, Santelmo N, Le Panse R, Berrih-Aknin S, Dragin N. Il-23/Th17 cell pathway: A promising target to alleviate thymic inflammation maintenance in myasthenia gravis. J Autoimmun. 2019 Mar;98:59-73. doi: 10.1016/j.jaut.2018.11.005. Epub 2018 Dec 18.
PubMed 30578016Li Y, Guptill JT, Russo MA, Howard JF Jr, Massey JM, Juel VC, Hobson-Webb LD, Emmett D, Chopra M, Raja S, Liu W, Yi JS. Imbalance in T follicular helper cells producing IL-17 promotes pro-inflammatory responses in MuSK antibody positive myasthenia gravis. J Neuroimmunol. 2020 Aug 15;345:577279. doi: 10.1016/j.jneuroim.2020.577279. Epub 2020 May 27.
PubMed 32497931Yilmaz V, Maillard S, Truffault F, Bolgert F, Behin A, Regnard JF, Berrih-Aknin S, Le Panse R. Regulatory B cells in myasthenia gravis are differentially affected by therapies. Ann Clin Transl Neurol. 2018 Sep 22;5(11):1408-1414. doi: 10.1002/acn3.645. eCollection 2018 Nov.
PubMed 30480034Bergantini L, d'Alessandro M, Cameli P, Vietri L, Vagaggini C, Perrone A, Sestini P, Frediani B, Bargagli E. Effects of rituximab therapy on B cell differentiation and depletion. Clin Rheumatol. 2020 May;39(5):1415-1421. doi: 10.1007/s10067-020-04996-7. Epub 2020 Feb 22.
PubMed 32088800
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rituximab for the Treatment of New-onset AChR-Myasthenia Gravis
- ClinicalTrials.gov ID
- NCT07071246
- Acronym / sponsor ID
- 202206-13
- Conditions
- Treatment
- Keywords
- myasthenia gravis, rituximab, efficacy, safety
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 17 Jul 2025 (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.
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.
Detailed description
Myasthenia gravis (MG) is the most common acquired disorder of neuromuscular junction (NMJ), in which pathogenic autoantibodies bind to components of the postsynaptic membrane in NMJ, the most common antibody (in 85% MG patients) being the nicotinic acetylcholine receptor (AChR), followed by muscle-specific kinase (MuSK) or lipoprotein related peptide 4 (LRP4), thereby making impairment of neuromuscular transmission, causing fatigable weakness and even representing a potentially life-threatening condition. Traditional medical treatments of new-onset MG include anticholinesterase inhibitors such as pyridostigmine for temporarily symptomatic relief, immunomodulating therapies such as intravenous immunoglobulin (IVIG) and plasma exchange (PLEX) for a rapid but short-term clinical response, and immunosuppressive agents such as corticosteroids, azathioprine, mycophenolate mofetil, cyclosporine, methotrexate and cyclophosphamide for long-term treatment. Moreover, accompanied with prolonged duration, approximately 20% of the generalized MG population develop to refractory progressive course even with long-time and sufficient traditional immunosuppressive agents. For all newly diagnosed MG patients, chest computed tomography (CT) scan must be performed to assess for thymoma, and thymectomy should be done immediately in those thymoma patients with IVIG or PLEX treatment 1 to 2 weeks prior to thymectomy for optimizing condition, then followed by additional medical therapy for a sustained disease control. 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. AChR-MG is an archetype for B cell-mediated autoimmune disorder, clearly implicating a principal role for B cells in the disease pathogenesis. Therefore, B lymphocytes have always been the focus of investigative interests, especially with the successful introduction of biological therapeutics that target these cells. 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, using MG Foundation of America (MGFA)-Postintervention Status (PIS) "Minimal Manifestation (MM) or better status" as the primary outcome, changes in Quantitative Myasthenia Gravis (QMG), Manual Muscle Testing (MMT), MG-Related Activities of Daily Living (MG-ADL), and 15-item Quality-of-Life (MGQOL-15) scores as the secondary outcomes, as well as cholinesterase inhibitors reduction, peripheral CD19+B-cell percentage, AChR antibody titers and adverse effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RTX intravenously for the treatment of myasthenia gravis | Other | Drug: Rituximab InjectionRTX administrating 100mg per week consecutively for 3 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (12 listed)
- 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;
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 |
|---|---|---|
| Rituximab InjectionAlso: RTXlow dose of rituximab intravenously | Drug | RTX intravenously for the treatment of myasthenia gravis |
Primary outcome
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
Time frame: 12 months
No functional impairment and some muscle weakness may be detected by a specialist neurologist
80% enrolled patients reached the clinical complete remission (CSR) of MGFA - post intervention status (PIs) at 2 years after administration of study drug
Time frame: 24 months
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
Safety: The incidence of treatment-related adverse reactions and withdrawal because of serious adverse reaction
Time frame: through study completion
Any adverse reaction, like fever, rash, dizziness and so on.
1 secondary outcome
The proportion of patients with ocular myasthenia gravis (OMG) progressed to generalized myasthenia gravis (GMG).
Time frame: After 2 years of follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- Background: PubMed 28029925Gilhus NE. Myasthenia Gravis. N Engl J Med. 2016 Dec 29;375(26):2570-2581. doi: 10.1056/NEJMra1602678. No abstract available.
- Background: PubMed 31901719Morren J, Li Y. Maintenance immunosuppression in myasthenia gravis, an update. J Neurol Sci. 2020 Mar 15;410:116648. doi: 10.1016/j.jns.2019.116648. Epub 2019 Dec 26.
- Background: PubMed 31828474Rath J, Brunner I, Tomschik M, Zulehner G, Hilger E, Krenn M, Paul A, Cetin H, Zimprich F. Frequency and clinical features of treatment-refractory myasthenia gravis. J Neurol. 2020 Apr;267(4):1004-1011. doi: 10.1007/s00415-019-09667-5. Epub 2019 Dec 11.
- Background: PubMed 32982957Mantegazza R, Antozzi C. From Traditional to Targeted Immunotherapy in Myasthenia Gravis: Prospects for Research. Front Neurol. 2020 Sep 2;11:981. doi: 10.3389/fneur.2020.00981. eCollection 2020.
- Background: PubMed 27358333Sanders DB, Wolfe GI, Benatar M, Evoli A, Gilhus NE, Illa I, Kuntz N, Massey JM, Melms A, Murai H, Nicolle M, Palace J, Richman DP, Verschuuren J, Narayanaswami P. International consensus guidance for management of myasthenia gravis: Executive summary. Neurology. 2016 Jul 26;87(4):419-25. doi: 10.1212/WNL.0000000000002790. Epub 2016 Jun 29.
- Background: PubMed 10891897Jaretzki A 3rd, Barohn RJ, Ernstoff RM, Kaminski HJ, Keesey JC, Penn AS, Sanders DB. Myasthenia gravis: recommendations for clinical research standards. Task Force of the Medical Scientific Advisory Board of the Myasthenia Gravis Foundation of America. Neurology. 2000 Jul 12;55(1):16-23. doi: 10.1212/wnl.55.1.16. No abstract available.
- Background: PubMed 32364568Brauner S, Eriksson-Dufva A, Hietala MA, Frisell T, Press R, Piehl F. Comparison Between Rituximab Treatment for New-Onset Generalized Myasthenia Gravis and Refractory Generalized Myasthenia Gravis. JAMA Neurol. 2020 Aug 1;77(8):974-981. doi: 10.1001/jamaneurol.2020.0851.
- Background: PubMed 32098874Di Stefano V, Lupica A, Rispoli MG, Di Muzio A, Brighina F, Rodolico C. Rituximab in AChR subtype of myasthenia gravis: systematic review. J Neurol Neurosurg Psychiatry. 2020 Apr;91(4):392-395. doi: 10.1136/jnnp-2019-322606. Epub 2020 Feb 25.
- Background: PubMed 35065040Punga AR, Maddison P, Heckmann JM, Guptill JT, Evoli A. Epidemiology, diagnostics, and biomarkers of autoimmune neuromuscular junction disorders. Lancet Neurol. 2022 Feb;21(2):176-188. doi: 10.1016/S1474-4422(21)00297-0.
- Background: PubMed 35065039Huijbers MG, Marx A, Plomp JJ, Le Panse R, Phillips WD. Advances in the understanding of disease mechanisms of autoimmune neuromuscular junction disorders. Lancet Neurol. 2022 Feb;21(2):163-175. doi: 10.1016/S1474-4422(21)00357-4.
- Background: PubMed 33184844Uzawa A, Kuwabara S, Suzuki S, Imai T, Murai H, Ozawa Y, Yasuda M, Nagane Y, Utsugisawa K. Roles of cytokines and T cells in the pathogenesis of myasthenia gravis. Clin Exp Immunol. 2021 Mar;203(3):366-374. doi: 10.1111/cei.13546. Epub 2020 Dec 3.
- Background: PubMed 30578016Villegas JA, Bayer AC, Ider K, Bismuth J, Truffault F, Roussin R, Santelmo N, Le Panse R, Berrih-Aknin S, Dragin N. Il-23/Th17 cell pathway: A promising target to alleviate thymic inflammation maintenance in myasthenia gravis. J Autoimmun. 2019 Mar;98:59-73. doi: 10.1016/j.jaut.2018.11.005. Epub 2018 Dec 18.
- Individual participant dataSharing planned: No
Related trials for Treatment
Active, not recruitingPhase 2
Compassionate Use of Metreleptin in Previously Treated People With Partial Lipodystrophy
Diabetes, Lipodystrophy
Not yet recruitingPhase 2
Retlirafusp Alfa or Adebrelimab Plus SOX as Neoadjuvant Therapy for HER2-Negative Resectable Gastric or Gastroesophageal Junction Adenocarcinoma
Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma
RecruitingPhase 3
A Study to Evaluate Effect of AZD6234 as an Adjunct to Incretin-based Therapies in Adult Participants With Obesity or Overweight With Weight-related Comorbidity With or Without Type 2 Diabetes Mellitus
Obesity or Overweight, Weight-Related Comorbidity
Not yet recruitingPhase 1/2
Combination ADI-PEG 20, TMZ, and RT for Treatment of Newly Diagnosed High-grade Glioma (HGG)
Glioblastoma, High-Grade Glioma (WHO III-IV)
Active, not recruitingPhase 2
Effects of Brain Stimulation on Food Intake and Behavioral Weight Loss Treatment
Electric Stimulation Therapy, Obesity
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rituximab Injection in people with Treatment, run by Tang-Du 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 10 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 17 Jul 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 12 months). The study lists 3 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 NCT07071246, which also lists 26 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 17 Jul 2025.