Registry of Participants With Generalized Myasthenia Gravis Treated With Alexion C5 Inhibition Therapies (C5ITs)

February 17, 2026 updated by: Alexion Pharmaceuticals, Inc.

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

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®).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Recruiting
        • Clinical Trial Site
  • Canada
    • Ontario
      • Brampton, Ontario, Canada, L6R 3J7
        • Recruiting
        • Clinical Trial Site
      • London, Ontario, Canada, N6A 5A5
        • Recruiting
        • Clinical Trial Site
    • Quebec
      • Montreal, Quebec, Canada, H2X 3E4
        • Recruiting
        • Clinical Trial Site
  • China
      • Beijing, China, 100730
        • Recruiting
        • Clinical Trial Site
      • Changchun, China, 130021
        • Recruiting
        • Clinical Trial Site
      • Chengdu, China, 610072
        • Recruiting
        • Clinical Trial Site
      • Guangzhou, China, 510080
        • Recruiting
        • Clinical Trial Site
      • Jinan, China, 250021
        • Recruiting
        • Clinical Trial Site
      • Nanchang, China, 330006
        • Recruiting
        • Clinical Trial Site
      • Qingdao, China, 266003
        • Recruiting
        • Clinical Trial Site
      • Shijiazhuang, China, 050000
        • Recruiting
        • Clinical Trial Site
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • Clinical Trial Site
  • Germany
    • Hannover
      • Hanover, Hannover, Germany, 30625
        • Recruiting
        • Clinical Trial Site
  • Italy
      • Milan, Italy, 20133
        • Recruiting
        • Clinical Trial Site
      • Naples, Italy, 80138
        • Recruiting
        • Clinical Trial Site
  • Saudi Arabia
      • Abhā, Saudi Arabia, 62523
        • Recruiting
        • Clinical Trial Site
      • Jeddah, Saudi Arabia, 22384
        • Recruiting
        • Clinical Trial Site
      • Riyadh, Saudi Arabia, 14611
        • Recruiting
        • Clinical Trial Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • Clinical Trial Site
    • Arizona
      • Scottsdale, Arizona, United States, 85251
        • Recruiting
        • Clinical Trial Site
    • California
      • Fresno, California, United States, 93710
        • Recruiting
        • Clinical Trial Site
      • Orange, California, United States, 92868
        • Recruiting
        • Clinical Trial Site
      • Rancho Mirage, California, United States, 92270
        • Recruiting
        • Clinical Trial Site
      • Sylmar, California, United States, 91342
        • Recruiting
        • Clinical Trial Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Recruiting
        • Clinical Trial Site
      • Fort Collins, Colorado, United States, 80528
        • Recruiting
        • Clinical Trial Site
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Recruiting
        • Clinical Trial Site
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 10010
        • Recruiting
        • Clinical Trial Site
    • Florida
      • Clearwater, Florida, United States, 33761
        • Recruiting
        • Clinical Trial Site
      • Gainesville, Florida, United States, 32608
        • Recruiting
        • Clincal Trial Site
      • Jacksonville, Florida, United States, 32209
        • Recruiting
        • Clinical Trial Site
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Clinical Trial Site
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Recruiting
        • Clinical Trial Site
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • Clinical Trial Site
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Recruiting
        • Clinical Trial Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Clinical Trial Site
    • Michigan
      • Lansing, Michigan, United States, 48824
        • Recruiting
        • Clinical Trial Site
    • Missouri
      • Columbia, Missouri, United States, 65212
        • Recruiting
        • Clinical Trial Site
    • New York
      • New Hyde Park, New York, United States, 11042
        • Recruiting
        • Clinical Trial Site
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • Clinical Trial Site
      • Charlotte, North Carolina, United States, 28207
        • Recruiting
        • Clinical Trial Site
      • Durham, North Carolina, United States, 27705
        • Recruiting
        • Clinical Trial Site
    • Ohio
      • Dayton, Ohio, United States, 45459
        • Recruiting
        • Clinical Trial Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Clinical Trial Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • Recruiting
        • Clinical Trial Site
      • Knoxville, Tennessee, United States, 37920
        • Recruiting
        • Clinical Trial Site
    • Texas
      • Dallas, Texas, United States, 75206
        • Recruiting
        • Clinical Trial Site
      • Houston, Texas, United States, 77030
        • Recruiting
        • Clinical Trial Site
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Recruiting
        • Clinical Trial Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Recruiting
        • Clinical Trial Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants with a diagnosis of gMG who are treated with Alexion C5IT at the time of enrollment, or have ever been treated with Alexion C5IT prior to enrollment, and meet the inclusion criteria and exclusion criteria are eligible for registry participation.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Myasthenia Gravis Activities of Daily Living (MG-ADL) Score
Time Frame: Approximately 5 years from enrollment
The MG-ADL is an eight-item patient-reported outcome measure assessing MG symptoms and functional activities related to activities of daily living.48 Each of the items is scored from 0 (normal) to 3 (most severe), providing a total MG-ADL score ranging from 0 to 24, where higher scores indicate greater severity of symptoms.
Approximately 5 years from enrollment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Collect Real-world Data On Other Outcomes Of Interest In Alexion C5IT-treated Participants
Time Frame: Up to 5 years
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Alexion Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 2, 2019

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 16, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 17, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ALXN-MG-501

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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