Registry for patients with generalized myasthenia gravis treated with C5 inhibitors
Official title: Long-Term, Observational, Global Registry of Patients With Generalized Myasthenia Gravis Who Have Received Treatment With Complement C5 Inhibition Therapies (C5ITs)
Run by Alexion Pharmaceuticals, Inc. · NCT04202341 · Data updated 2026-11-12
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 type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | Alexion Pharmaceuticals, Inc. Industry-sponsored |
| Drugs / interventions | eculizumab, ravulizumab |
| Locations | 51 sites (Birmingham, Alabama and 50 other locations) |
| Status | Recruiting |
| Started | December 2, 2019 |
| Main results expected | October 1, 2029 |
| Study ends | October 1, 2029 |
| Registry record updated | February 18, 2026 |
| Trial ID | NCT04202341 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals diagnosed with generalized myasthenia gravis who are currently receiving Alexion C5 inhibition therapies.
✕Probably not a fit
Patients who are currently enrolled in an interventional clinical study for gMG treatment will not benefit from this registry.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies involving observational registries for chronic conditions have shown success in improving treatment understanding and patient outcomes.
Who can join: the full rules
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 it's running
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Birmingham, Alabama, United States Recruiting -
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Scottsdale, Arizona, United States Recruiting -
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Fresno, California, United States Recruiting -
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Orange, California, United States Recruiting -
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Rancho Mirage, California, United States Recruiting -
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Sylmar, California, United States Recruiting
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Colorado Springs, Colorado, United States Recruiting -
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Fort Collins, Colorado, United States Recruiting -
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New Haven, Connecticut, United States Recruiting -
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Washington D.C., District of Columbia, United States Recruiting -
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Clearwater, Florida, United States Recruiting -
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Gainesville, Florida, United States Recruiting -
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Jacksonville, Florida, United States Recruiting -
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Tampa, Florida, United States Recruiting -
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Augusta, Georgia, United States Recruiting -
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Iowa City, Iowa, United States Recruiting -
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Lexington, Kentucky, United States Recruiting -
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Boston, Massachusetts, United States Recruiting -
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Lansing, Michigan, United States Recruiting -
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Columbia, Missouri, United States Recruiting -
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New Hyde Park, New York, United States Recruiting -
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Dayton, Ohio, United States Recruiting -
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Philadelphia, Pennsylvania, United States Recruiting -
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Burlington, Vermont, United States Recruiting -
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Milwaukee, Wisconsin, United States Recruiting -
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Vienna, Austria Recruiting -
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Brampton, Ontario, Canada Recruiting -
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London, Ontario, Canada Recruiting -
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Montreal, Quebec, Canada Recruiting -
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Chengdu, Sichuan, China Recruiting -
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Beijing, China Recruiting -
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Changchun, China Recruiting -
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Guangzhou, China Recruiting -
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Jinan, China Recruiting -
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Nanchang, China Recruiting -
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Qingdao, China Recruiting -
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Shijiazhuang, China Recruiting -
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Hanover, Hannover, Germany Recruiting -
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Milan, Italy Recruiting -
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Naples, Italy Recruiting -
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Abhā, Saudi Arabia Recruiting -
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Jeddah, Saudi Arabia Recruiting
+1 more sites. See ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Alexion Pharmaceuticals, Inc. (Sponsor)
- Email: clinicaltrials@alexion.com
- Phone: 1-855-752-2356
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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SHR-2173 injection added to standard care for generalized myasthenia gravis
This Phase 2 trial tests whether SHR-2173 added to usual treatment helps adults with generalized myasthenia gravis more than a placebo add-on.
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Ravulizumab for Generalized Myasthenia Gravis in Chinese Adults
This trial tests ravulizumab in Chinese adults with generalized myasthenia gravis to see if it helps symptoms while checking safety and how the drug behaves in the body.
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Tracking Real-Life Myasthenia Gravis Symptoms in Patients on Rozanolixizumab
This observational study follows adults with generalized myasthenia gravis who are treated with Rozanolixizumab to see how their symptoms and fatigue change in real life.
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ADAPT Forward master protocol testing multiple regimens for generalized myasthenia gravis
This platform tests several drug regimens, including efgartigimod IV and empasiprubart IV, in adults with generalized myasthenia gravis to find safer and more effective treatment combinations.
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Adding empasiprubart to efgartigimod for AChR-antibody positive generalized myasthenia gravis
This trial will test whether adding empasiprubart to efgartigimod infusions helps people with AChR-antibody positive generalized myasthenia gravis who have only had a partial response to efgartigimod.
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Oral steroid tapering for adults with generalized myasthenia gravis on ravulizumab.
This study will try a predefined prednisone taper to see if adults with generalized myasthenia gravis on ravulizumab can safely reduce their daily steroid dose.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.