Registry of Participants With Generalized Myasthenia Gravis Treated With Alexion C5 Inhibition Therapies (C5ITs)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Generalized Myasthenia Gravis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Austria, Canada, China, Germany +2
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Long-Term, Observational, Global Registry of Patients With Generalized Myasthenia Gravis Who Have Received Treatment With Complement C5 Inhibition Therapies (C5ITs)
Overview
Long-term, multicenter, multinational, observational, registry of patients with gMG that is designed to collect data on clinical outcomes and safety in patients prescribed Alexion C5 inhibitor therapies (C5IT) such as eculizumab (Soliris®) and ravulizumab (Ultomiris®).
Detailed description
At the time of enrollment in the Registry, participant records will be queried for retrospective information about the participants' medical history and gMG disease treatment history. Following enrollment, prospective data collection will be performed using data obtained as part of the routine clinical care and through patient-reported outcome methods in use. Data will be collected using an electronic data capture system. The duration of data collection for the Registry will be up to 5 years from the day of enrollment.
Primary outcome measures
- Change in Myasthenia Gravis Activities of Daily Living (MG-ADL) Score [Time frame: Approximately 5 years from enrollment]
Eligibility criteria
Inclusion criteria
- 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with Alexion C5IT at the time of enrollment, including patients previously treated with Soliris or Ultomiris and withdrawn from treatment.
- Capable of giving signed informed consent, which includes compliance with the protocol requirements and restrictions.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 32 centers
- Clinical Trial Site — Birmingham
- Clinical Trial Site — Scottsdale
- Clinical Trial Site — Fresno
- Clinical Trial Site — Orange
- Clinical Trial Site — Rancho Mirage
- Clinical Trial Site — Sylmar
- Clinical Trial Site — Colorado Springs
- Clinical Trial Site — Fort Collins
- … and 24 more centers
China · 9 centers
- Clinical Trial Site — Chengdu
- Clinical Trial Site — Beijing
- Clinical Trial Site — Changchun
- Clinical Trial Site — Chengdu
- Clinical Trial Site — Guangzhou
- Clinical Trial Site — Jinan
- Clinical Trial Site — Nanchang
- Clinical Trial Site — Qingdao
- … and 1 more center
Canada · 3 centers
- Clinical Trial Site — Brampton
- Clinical Trial Site — London
- Clinical Trial Site — Montreal
Saudi Arabia · 3 centers
- Clinical Trial Site — Abhā
- Clinical Trial Site — Jeddah
- Clinical Trial Site — Riyadh
Italy · 2 centers
- Clinical Trial Site — Milan
- Clinical Trial Site — Naples
Austria · 1 center
- Clinical Trial Site — Vienna
Germany · 1 center
- Clinical Trial Site — Hanover
Publications
- Howard JF Jr, Dodig D, Zeinali L, Macwan SP, Yegin A, Pulley MT, Rodrigues E, Narayanaswami P. First analysis of the Myasthenia Gravis SPOTLIGHT Registry: outcomes with eculizumab and ravulizumab. J Neurol Sci. 2025 Sep 15;476:123628. doi: 10.1016/j.jns.2025.123628. Epub 2025 Jul 16. PMID 40812271
Identifiers
NCT: NCT04202341 · ALXN-MG-501