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NCT04202341Recruiting

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

Alexion Pharmaceuticals, Inc.

Start Date

12/2/2019

Completion Date

10/1/2029

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®).

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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with Alexion C5IT at the time of enrollment, including patients previously treated with Soliris or Ultomiris and withdrawn from treatment. 2.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.

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Conditions

Generalized Myasthenia Gravis

Locations

Clinical Trial Site

Birmingham, Alabama 35294

United States

Clinical Trial Site

Scottsdale, Arizona 85251

United States

Clinical Trial Site

Fresno, California 93710

United States

Clinical Trial Site

Orange, California 92868

United States

Clinical Trial Site

Rancho Mirage, California 92270

United States

Clinical Trial Site

Sylmar, California 91342

United States

Clinical Trial Site

Colorado Springs, Colorado 80907

United States

Clinical Trial Site

Fort Collins, Colorado 80528

United States

Clinical Trial Site

New Haven, Connecticut 06520

United States

Clinical Trial Site

Washington D.C., District of Columbia 10010

United States

Clinical Trial Site

Clearwater, Florida 33761

United States

Clincal Trial Site

Gainesville, Florida 32608

United States

Clinical Trial Site

Jacksonville, Florida 32209

United States

Clinical Trial Site

Tampa, Florida 33612

United States

Clinical Trial Site

Augusta, Georgia 30912

United States

Clinical Trial Site

Iowa City, Iowa 52242

United States

Clinical Trial Site

Lexington, Kentucky 40503

United States

Clinical Trial Site

Boston, Massachusetts 02215

United States

Clinical Trial Site

Lansing, Michigan 48824

United States

Clinical Trial Site

Columbia, Missouri 65212

United States

Clinical Trial Site

New Hyde Park, New York 11042

United States

Clinical Trial Site

Chapel Hill, North Carolina 27599

United States

Clinical Trial Site

Charlotte, North Carolina 28207

United States

Clinical Trial Site

Durham, North Carolina 27705

United States

Clinical Trial Site

Dayton, Ohio 45459

United States

Clinical Trial Site

Philadelphia, Pennsylvania 19104

United States

Clinical Trial Site

Chattanooga, Tennessee 37403

United States

Clinical Trial Site

Knoxville, Tennessee 37920

United States

Clinical Trial Site

Dallas, Texas 75206

United States

Clinical Trial Site

Houston, Texas 77030

United States

Clinical Trial Site

Burlington, Vermont 05401

United States

Clinical Trial Site

Milwaukee, Wisconsin 53215

United States

Clinical Trial Site

Vienna, 1090

Austria

Clinical Trial Site

Brampton, Ontario L6R 3J7

Canada

Clinical Trial Site

London, Ontario N6A 5A5

Canada

Clinical Trial Site

Montreal, Quebec H2X 3E4

Canada

Clinical Trial Site

Chengdu, Sichuan 610041

China

Clinical Trial Site

Beijing, 100730

China

Clinical Trial Site

Changchun, 130021

China

Clinical Trial Site

Chengdu, 610072

China

Clinical Trial Site

Guangzhou, 510080

China

Clinical Trial Site

Jinan, 250021

China

Clinical Trial Site

Nanchang, 330006

China

Clinical Trial Site

Qingdao, 266003

China

Clinical Trial Site

Shijiazhuang, 050000

China

Clinical Trial Site

Hanover, Hannover 30625

Germany

Clinical Trial Site

Milan, 20133

Italy

Clinical Trial Site

Naples, 80138

Italy

Clinical Trial Site

Abhā, 62523

Saudi Arabia

Clinical Trial Site

Jeddah, 22384

Saudi Arabia

Clinical Trial Site

Riyadh, 14611

Saudi Arabia