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

March 15, 2024 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

Recruiting

Conditions

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

Observational

Enrollment (Estimated)

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 Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • Clinical Trial Site
    • Arizona
      • Phoenix, Arizona, United States, 85001
        • Recruiting
        • Clinical Trial Site
    • California
      • Fresno, California, United States, 93710
        • 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
    • Florida
      • Clearwater, Florida, United States, 33761
        • Recruiting
        • Clinical Trial Site
      • Gainesville, Florida, United States, 32608
        • Recruiting
        • Clincal Trial Site
      • Tampa, Florida, United States, 33620
        • Recruiting
        • Clinical Trial Site
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Recruiting
        • Clinical Trial Site
    • Illinois
      • Lake Barrington, Illinois, United States, 60010
        • 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
    • Nevada
      • Las Vegas, Nevada, United States, 89145
        • 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, 27514
        • Recruiting
        • Clinical Trial Site
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Clinical Trial Site
    • Ohio
      • Dayton, Ohio, United States, 45459
        • Recruiting
        • Clinical Trial Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Clinical Trial Site
    • Texas
      • Dallas, Texas, United States, 75206
        • Recruiting
        • Clinical Trial Site
      • Houston, Texas, United States, 77001
        • 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

Ages Eligible for Study

18 years and older (Child, 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

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

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

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)

December 2, 2019

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

December 16, 2019

First Submitted That Met QC Criteria

December 16, 2019

First Posted (Actual)

December 17, 2019

Study Record Updates

Last Update Posted (Actual)

March 18, 2024

Last Update Submitted That Met QC Criteria

March 15, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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