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PANORAMA: Neuromuscular Organoids for Refractory AChR+ Myasthenia Gravis

Recruitingn/aAges 18 Years - anyAllFondazione IRCCS Ca' Granda, Ospedale Maggiore Po…
NCT07717281 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Myasthenia gravis (MG) is an autoimmune disease in which autoantibodies attack the neuromuscular junction, the site at which nerve cells communicate with muscle fibres, impairing signal transmission and causing fluctuating muscle weakness that worsens with sustained activity. In most patients this dysfunction is reversible and improves with treatments that suppress the immune response. About 10 to 15 percent of patients do not respond adequately to standard therapy, and the mechanisms of this refractory course remain unclear. The study is based on the hypothesis that in refractory patients the autoantibody attack causes irreversible damage to the neuromuscular junction, and that this damage sustains symptoms despite appropriate treatment. A further aim is to identify circulating biomarkers reflecting such damage that may help predict response to therapy. The study includes adults with

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📋 Eligibility rules (as published)
Inclusion Criteria: AChR-positive MG participants (all of the following): * Age \>= 18 years * Established diagnosis of myasthenia gravis according to international criteria (fluctuating muscle weakness plus at least one of: positive anticholinesterase test; \>10% decrement on repetitive nerve stimulation \[SR-ENG\]; or increased jitter on single-fiber EMG \[SFEMG\]) * Anti-AChR antibody positivity confirmed by serological testing * Generalized MG stratified by disease duration and response to conventional immunosuppressive therapy into: treatment-naive MG (nMG); treatment-sensitive MG with stable disease and at least 12 months of follow-up (sMG); or treatment-refractory MG with at least 12 months of follow-up (rMG) * Signed informed consent (prospective component) * For the retrospective component, availability of biobanked biological samples with a signed specific informed consent Control participants (all of the following): * Age \>= 18 years * Absence of neuromuscular disease * Absence of known autoimmune disease * No ongoing immunosuppressive or immunomodulatory therapy * Negative for anti-AChR and anti-MuSK antibodies * Age- and sex-matched to the MG groups * Signed informed consent Exclusion Criteria: * Seronegative (AChR-negative) generalized MG, or MG with anti-MuSK or other non-AChR antibodies * Purely ocular myasthenia gravis * Other concomitant neuromuscular disease (e.g., Lambert-Eaton myasthenic syndrome, polymyositis, muscular dystrophies) * Pregnancy or breastfeeding * Inability to provide informed consent
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What it tests

  • Not listed
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Where

1 site
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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