RecruitingNCT07570589

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)

An Observational, Prospective, Multicenter, Open-label Study to 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)


Sponsor

Centre Hospitalier Universitaire de Nice

Enrollment

50 participants

Start Date

Jun 15, 2026

Study Type

OBSERVATIONAL

Conditions

Summary

Generalized Myasthenia Gravis (gMG) is a rare autoimmune disease (a disease in which the body attacks its own tissues) that causes muscle weakness and significant fatigue. Current treatments (corticosteroids, plasma exchange, intravenous immunoglobulin infusions) improve symptoms in many patients. However, many continue to suffer from fatigue and fatigability that are not well measured by standard tools. Moreover, these treatments can cause significant long-term side effects, reducing quality of life. New treatments such as Rozanolixizumab (ROZ) are now available. They act rapidly and are well tolerated, allowing better symptom control while reducing the risks associated with conventional treatments. To properly evaluate these new treatments, it is essential to understand patients' perspectives on their effectiveness. The scales used by physicians do not always capture all the symptoms experienced by patients, particularly fatigability. This is why a new tool has been developed: the MG symptoms PRO. This questionnaire allows patients to assess their own symptoms (fatigue, weakness of the eyes, mouth, breathing, muscle fatigability) in detail. This research aims to better understand the effectiveness of treatments from the patients' perspective in order to improve their care. The goal of the study is to evaluate the impact of Rozanolixizumab administration in real-world practice through the MG symptoms PRO questionnaire. This is an observational study, meaning that the medication is prescribed by the physician according to current regulations, and the study simply collects routine medical data during your follow-up, over a period of approximately 9 months.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Patients diagnosed with generalized myasthenia gravis and treated with Rozanolixizumab for people with generalized myasthenia gravis. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERPatients diagnosed with generalized myasthenia gravis and treated with Rozanolixizumab

Patients are evaluated using the MG Symptoms PRO questionnaire


Locations(11)

CHU de NICE

Nice, Alpes-maritimes, France

CHu d'Angers

Angers, France

Ch de Boulogne sur Mer

Boulogne-sur-Mer, France

Hôpital Henri Mondor

Créteil, France

Hôpital Raymond Pointcarré

Garches, France

CHU de Grenoble

Grenoble, France

GHICL Saint Vincent de Paul

Lille, France

CHU de LILLE

Lille, France

Chu Dupuytren 1

Limoges, France

CHU Charles Nicolle

Rouen, France

CHU de Toulouse

Toulouse, France

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NCT07570589


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