Early ravulizumab for adults with myasthenic crisis in the ICU

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational program of adults with AChR-antibody–positive generalized myasthenia gravis admitted to the intensive care unit for a myasthenic crisis who receive ravulizumab following plasma exchange or IVIg according to local practice. Clinical data during the ICU stay—such as duration of mechanical ventilation, length of ICU stay, complications, and clinical recovery measures—are collected. Treatment decisions follow local labeling and validation by the French FILNEMUS network, with the protocol documenting early use of the long-acting complement C5 inhibitor ravulizumab. The design is non-randomized and observational, aiming to describe outcomes and safety in this specific, high-acuity setting.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Male or female aged ≥18 years.
* Diagnosed with gMG with confirmed documentation and supported by a physical exam and confirmed seropositivity for AChR-Abs.
* Patients having received more than 1 cycle of PLEX or IVIg 1-2 g/kg (max 50g/day), according to clinical practice.
* Meets the clinical criteria as defined by the Myasthenia Gravis Foundation of America (MFGA) for generalized MG class V - IV, at ICU admission.
* Patients treated with at least one standard MG-targeted therapy.
* Patients receiving Ravulizumab following PLEX of IVIg during their stay in the ICU, as per local label and reimbursement conditions. The prescription must be validated by experts from the French Health Care Network for rare neuromuscular diseases FILNEMUS.
* Patients capable of understanding written informed consent and providing signed, dated, and witnessed written informed consent. If unable to sign the consent due to muscular weakness, a dedicated informed consent can be signed by a trusted witness.
* Patients willing and able to comply with scheduled visits, treatment plan, study restrictions and other study procedures.
* Patients affiliated to a European social security system.
* Patients agree to comply with the prevention of meningococcal infections by vaccination and/or antibiotic prophylaxis in accordance with the current local vaccination/antibiotic prophylaxis recommendations.
* Patients with no contraindication to anti-C5 treatment.
* Patients with no contraindication to antibiotic therapy.

Exclusion Criteria:

* Active infection or other disorders causing weakness, known immunoglobulin A deficiency, active renal or hepatic disease, clinically significant cardiac disease, known hyperviscosity, or hypercoagulable state.
* Any active malignancy.
* Presence of antibodies other than anti-AChR-Ab+ (anti-titin-Ab+ were permitted as these are considered complementary markers to anti-AChR-Ab+).
* Patient with a diagnosed thymoma.
* Patient with a pathology judged by the investigator to interfere with the proper conduct of the study.
* Positive pregnancy test. A urine pregnancy test will be carried out for women of childbearing age.
* 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.
* Vaccination with live or live-attenuated vaccines within the 6 weeks.
* Refusal of the subject to participate in the study.
* 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.
* Known hypersensitivity to the active substance or to any of the excipients.

Where it's running

• CHU de NICE
  Nice, Alpes-maritimes, France Recruiting
• Aphp
  Le Kremlin-Bicêtre, France Recruiting
• CHU de Lille
  Lille, France Recruiting
• CHu de la Timone
  Marseille, France Recruiting
• Hôpitaux universitaires de Strasbourg
  Strasbourg, France Recruiting
• Hospices Civils de Lyon
  Bron, France Not yet recruiting

Study contacts

• Study coordinator: Sabrina SACCONI
• Email: sacconi.s@chu-nice.fr
• Phone: 0492035757

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Ravulizumab for Generalized Myasthenia Gravis in Chinese Adults

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• Ravulizumab Outcomes in Polish Patients with aHUS

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.