Monitor the Evolution of Myasthenia Gravis Symptoms in Real-life in Patients With Anti-AChR and Anti-MUSK Generalised Myasthenia Gravis in Therapy With RYSTIGGO® (Rozanolixizumab)

Korábbi kezelés

• Patient receiving concomitant treatment with rituximab, anti-FcRn, complement inhibitors and/or PLEX;

Más betegség

• Any current mental condition (psychiatric disorder, senility, or dementia) that, in the opinion of the investigator, may affect study compliance or prevent understanding of the aims, investigational procedures, or possible consequences of the study; and/or patient with a Mini-mental State evaluation (MMSE) of <25;
• History of any illness or any clinical condition that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject;
• History of ongoing malignancy (except basal cell and squamous cell carcinomas of the skin, or in situ carcinoma of the cervix uteri that have been completely excised and cured);
• Clinically significant uncontrolled active or chronic bacterial, viral, or fungal infection at inclusion;
• Patient with end-stage diseases or with a disease that will enable him to be evaluated and/or treated;
• Patients with non-treated active infections;
• Patients with hypersensitivity to the active substance(s) or to any of the excipients, specifically: histidine, histidine hydrochloride monohydrate, proline, polysorbate 80, or water for injections.

Egyéb

• Patients discontinued from rituximab without respecting the administration rules of ROZ;
• Subject, or close relative of the subject, is the investigator or a sub-investigator, research assistant, pharmacist, study coordinator, or other staff directly involved with the conduct of the study at that site;
• Patient protected by law, under guardianship or curator ship, or not able to participate in a clinical study according to the article L.1121-16 of the French Public Health Code

• Male or female subjects aged ≥18 years;
• Diagnosed with MG with confirmed documentation and supported by a physical exam and confirmed seropositivity for anti AChR or anti MUSK antibodies;
• Meets the clinical criteria as defined by the Myasthenia Gravis Foundation of America (MFGA) for generalized MG class IIa, IIb, IIIa, and IIIb;
• Patient suitable for ROZ treatment (IgG ≥ 5,5 g/l);
• Patient naïve for ROZ treatment, or receiving the last dose more than 3 months prior inclusion;
• MG-ADL score ≥ 3 (with ≥ 3 points of non-ocular symptoms);
• Patient must have received all mandatory vaccinations according to local regulations prior to study enrollment;
• Capable of understanding the written informed consent, and providing signed, dated, and witnessed written informed consent;
• Willing and able to comply with scheduled visits, treatment plan, study restrictions, laboratory tests, contraceptive guidelines, and other study procedures;
• Patient affiliated to a European social security system.