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

Last updated: April 28, 2025
Sponsor: Alexion Pharmaceuticals, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Polymyositis (Inflammatory Muscle Disease)

Neuropathy

Sarcopenia

Treatment

N/A

Clinical Study ID

NCT04202341
ALXN-MG-501
  • Ages > 18
  • All Genders

Study Summary

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®).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Participants with a diagnosis of gMG who are treated with Alexion C5IT at the timeof enrollment, including patients previously treated with Soliris or Ultomiris andwithdrawn from treatment.

  2. Capable of giving signed informed consent, which includes compliance with theprotocol requirements and restrictions.

  3. Participants must have myasthenia gravis historical data, such as MG-ADL and MGFAclass, available to be enrolled in the Registry.

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 500
Study Start date:
December 02, 2019
Estimated Completion Date:
December 31, 2029

Study 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.

Connect with a study center

  • Clinical Trial Site

    Vienna, 1090
    Austria

    Active - Recruiting

  • Clinical Trial Site

    Brampton, Ontario L6R 3J7
    Canada

    Active - Recruiting

  • Clinical Trial Site

    London, Ontario N6A 5A5
    Canada

    Active - Recruiting

  • Clinical Trial Site

    Montreal, Quebec H2X 3E4
    Canada

    Active - Recruiting

  • Clinical Trial Site

    Chengdu, Sichuan 610041
    China

    Active - Recruiting

  • Clinical Trial Site

    Hanover, Hannover 30625
    Germany

    Active - Recruiting

  • Clinical Trial Site

    Milano, 20133
    Italy

    Active - Recruiting

  • Clinical Trial Site

    Naples, 80138
    Italy

    Active - Recruiting

  • Clinical Trial Site

    Birmingham, Alabama 35294
    United States

    Active - Recruiting

  • Clinical Trial Site

    Phoenix, Arizona 85001
    United States

    Site Not Available

  • Clinical Trial Site

    Scottsdale, Arizona 85251
    United States

    Active - Recruiting

  • Clinical Trial Site

    Fresno, California 93710
    United States

    Active - Recruiting

  • Clinical Trial Site

    Orange, California 92868
    United States

    Active - Recruiting

  • Clinical Trial Site

    Rancho Mirage, California 92270
    United States

    Active - Recruiting

  • Clinical Trial Site

    Sylmar, California 91342
    United States

    Active - Recruiting

  • Clinical Trial Site

    Colorado Springs, Colorado 80907
    United States

    Active - Recruiting

  • Clinical Trial Site

    Fort Collins, Colorado 80528
    United States

    Active - Recruiting

  • Clinical Trial Site

    New Haven, Connecticut 06520
    United States

    Active - Recruiting

  • Clinical Trial Site

    Washington, District of Columbia 10010
    United States

    Active - Recruiting

  • Clinical Trial Site

    Clearwater, Florida 33761
    United States

    Active - Recruiting

  • Clincal Trial Site

    Gainesville, Florida 32608
    United States

    Active - Recruiting

  • Clinical Trial Site

    Jacksonville, Florida 32209
    United States

    Active - Recruiting

  • Clinical Trial Site

    Tampa, Florida 33612
    United States

    Active - Recruiting

  • Clinical Trial Site

    Augusta, Georgia 30912
    United States

    Active - Recruiting

  • Clinical Trial Site

    Lake Barrington, Illinois 60010
    United States

    Site Not Available

  • Clinical Trial Site

    Rolling Meadows, Illinois 60008
    United States

    Site Not Available

  • Clinical Trial Site

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

  • Clinical Trial Site

    Lexington, Kentucky 40503
    United States

    Active - Recruiting

  • Clinical Trial Site

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Clinical Trial Site

    Lansing, Michigan 48824
    United States

    Active - Recruiting

  • Clinical Trial Site

    Columbia, Missouri 65212
    United States

    Active - Recruiting

  • Clinical Trial Site

    Las Vegas, Nevada 89145
    United States

    Site Not Available

  • Clinical Trial Site

    New Hyde Park, New York 11042
    United States

    Active - Recruiting

  • Clinical Trial Site

    Chapel Hill, North Carolina 27599
    United States

    Active - Recruiting

  • Clinical Trial Site

    Charlotte, North Carolina 28207
    United States

    Active - Recruiting

  • Clinical Trial Site

    Durham, North Carolina 27705
    United States

    Active - Recruiting

  • Clinical Trial Site

    Dayton, Ohio 45459
    United States

    Active - Recruiting

  • Clinical Trial Site

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Clinical Trial Site

    Chattanooga, Tennessee 37403
    United States

    Active - Recruiting

  • Clinical Trial Site

    Knoxville, Tennessee 37920
    United States

    Active - Recruiting

  • Clinical Trial Site

    Dallas, Texas 75206
    United States

    Active - Recruiting

  • Clinical Trial Site

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Clinical Trial Site

    Burlington, Vermont 05401
    United States

    Active - Recruiting

  • Clinical Trial Site

    Milwaukee, Wisconsin 53215
    United States

    Active - Recruiting

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