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

Description

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®).

Conditions

Generalized Myasthenia Gravis

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Study Overview

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Study Details

Study 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®).

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

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

Condition
Generalized Myasthenia Gravis
Intervention / Treatment

-

Contacts and Locations

Birmingham

Clinical Trial Site, Birmingham, Alabama, United States, 35294

Scottsdale

Clinical Trial Site, Scottsdale, Arizona, United States, 85251

Fresno

Clinical Trial Site, Fresno, California, United States, 93710

Orange

Clinical Trial Site, Orange, California, United States, 92868

Rancho Mirage

Clinical Trial Site, Rancho Mirage, California, United States, 92270

Sylmar

Clinical Trial Site, Sylmar, California, United States, 91342

Colorado Springs

Clinical Trial Site, Colorado Springs, Colorado, United States, 80907

Fort Collins

Clinical Trial Site, Fort Collins, Colorado, United States, 80528

New Haven

Clinical Trial Site, New Haven, Connecticut, United States, 06520

Washington

Clinical Trial Site, Washington, District of Columbia, United States, 10010

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Alexion Pharmaceuticals, Inc.,

Study Record Dates

2029-12-31