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NCT07071246Fut, nem toboroz

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

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. júl. 17.

Következő lépések

Rövid összefoglaló (regiszter, angolul)

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.

Állapot (regiszter)
Fut, nem toboroz
Vizsgálattípus
Beavatkozással járó
Résztvevők száma
30 (tervezett)
Első benyújtás
2022. júl. 12.
Kezdés
2022. aug. 1.
Elsődleges befejezés
2027. jún. 30.
Fő szponzor
Tang-Du Hospital
NCT-szám
NCT07071246

Mit vállalsz

  • Vizsgálat típusa: Beavatkozással járó
  • Tervezett résztvevők: 30
  • 2022. aug. 1. és az elsődleges befejezés (2027. jún. 30.) között
  • 1 helyszín, 1 országban
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.

Ki nem vehet részt

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Korábbi kezelés

  • Vaccination history within 4 weeks before enrollment;

Más betegség

  • 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.;

Laborértékek

  • Liver and kidney insufficiency or elevated transaminases (AST/ALT elevation exceeds 2.5 times the upper limit of normal)

Egyéb

  • 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.

Kiket keres a vizsgálat

  • 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.

Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (1)

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HelyszínVárosOrszágHelyszín állapota
Tangdu Hospital, Fourth Military Medical UniversityXi'anKínaIsmeretlen állapot

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