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

Study Identifier:
ALXN-MG-501
ClinicalTrials.gov Identifier:
NCT04202341
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
1-855-752-2356 or [email protected]
Recruiting

Study Details

Medical Condition
  • Generalized Myasthenia Gravis
Study Drug
    Date
    Dec 2019 - Dec 2029
    Phase 1
    Phase 2
    Phase 3
    Phase 4
    N/A
    Patient Requirements
    Sex: Female & Male
    Age: 18+ years
    Requirements Information
    Inclusion and Exclusion Criteria
    Inclusion 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with Alexion C5IT at the time of enrollment, including patients previously treated with Soliris or Ultomiris and withdrawn from treatment.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.
    Sex
    Female & Male
    Age
    18+ years

    Study Details

    Medical Condition
    • Generalized Myasthenia Gravis
    Study Drug
      Date
      Dec 2019 - Dec 2029
      Phase 1
      Phase 2
      Phase 3
      Phase 4
      N/A
      Patient Requirements
      Sex: Female & Male
      Age: 18+ years years
      Requirements Information
      Inclusion and Exclusion Criteria
      Inclusion 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with Alexion C5IT at the time of enrollment, including patients previously treated with Soliris or Ultomiris and withdrawn from treatment.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.

      Protocol 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®).

      Trial Locations

      Location
      Status
      Location
      Clinical Trial Site
      Birmingham, Alabama, United States, 35294
      Status
      Recruiting
      Location
      Clinical Trial Site
      Scottsdale, Arizona, United States, 85251
      Status
      Recruiting
      Location
      Clinical Trial Site
      Fresno, California, United States, 93710
      Status
      Recruiting
      Location
      Clinical Trial Site
      Orange, California, United States, 92868
      Status
      Recruiting
      Location
      Clinical Trial Site
      Rancho Mirage, California, United States, 92270
      Status
      Recruiting
      Location
      Clinical Trial Site
      Sylmar, California, United States, 91342
      Status
      Recruiting
      Go to page