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Registry for patients with generalized myasthenia gravis treated with C5 inhibitors

Long-Term, Observational, Global Registry of Patients With Generalized Myasthenia Gravis Who Have Received Treatment With Complement C5 Inhibition Therapies (C5ITs)

Observational Alexion Pharmaceuticals, Inc. · NCT04202341

This study is collecting long-term information from people with generalized myasthenia gravis who are being treated with C5 inhibitors to see how well these treatments work and if they are safe.

Quick facts

Study typeObservational
Enrollment500 (estimated)
Ages18 Years and up
SexAll
SponsorAlexion Pharmaceuticals, Inc. Industry-sponsored
Drugs / interventionseculizumab, ravulizumab
Locations51 sites (Birmingham, Alabama and 50 other locations)
Trial IDNCT04202341 on ClinicalTrials.gov

What this trial studies

This observational registry collects long-term data on patients diagnosed with generalized myasthenia gravis (gMG) who are being treated with Alexion C5 inhibition therapies, such as eculizumab and ravulizumab. Participants will provide retrospective medical history and treatment data at enrollment, followed by prospective data collection through routine clinical care and patient-reported outcomes. The registry aims to gather information over a period of up to five years to assess clinical outcomes and safety of these therapies.

Who should consider this trial

Good fit: Ideal candidates are individuals diagnosed with generalized myasthenia gravis who are currently receiving Alexion C5 inhibition therapies.

Not a fit: Patients who are currently enrolled in an interventional clinical study for gMG treatment will not benefit from this registry.

Why it matters

Potential benefit: If successful, this registry could enhance understanding of the effectiveness and safety of C5 inhibitors in treating generalized myasthenia gravis, potentially leading to improved patient care.

How similar studies have performed: Other studies involving observational registries for chronic conditions have shown success in improving treatment understanding and patient outcomes.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Participants with a diagnosis of gMG who are treated with Alexion C5IT at the time of enrollment, including patients previously treated with Soliris or Ultomiris and withdrawn from treatment.
2. Capable of giving signed informed consent, which includes compliance with the protocol requirements and restrictions.
3. Participants must have myasthenia gravis historical data, such as MG-ADL and MGFA class, available to be enrolled in the Registry.

Exclusion Criteria:

1\. Participants currently enrolled in an Alexion-sponsored interventional clinical study for treatment of gMG cannot be enrolled in the Alexion gMG Registry while enrolled/participating in the clinical study for gMG therapy.

Where this trial is running

Birmingham, Alabama and 50 other locations

+1 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Generalized Myasthenia GravisgMGSolirisUltomirisAlexion C5 Inhibition TherapyAlexion C5ITPatient RegistryAlexion Registry
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.