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

NCT ID: NCT04202341

Last Updated: 2025-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-02

Study Completion Date

2029-10-01

Brief Summary

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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

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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.

Conditions

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Generalized Myasthenia Gravis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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with Alexion C5IT at the time of enrollment, including patients previously treated with Soliris or Ultomiris and withdrawn from treatment.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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alexion Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinical Trial Site

Birmingham, Alabama, United States

Site Status RECRUITING

Clinical Trial Site

Scottsdale, Arizona, United States

Site Status RECRUITING

Clinical Trial Site

Fresno, California, United States

Site Status RECRUITING

Clinical Trial Site

Orange, California, United States

Site Status RECRUITING

Clinical Trial Site

Rancho Mirage, California, United States

Site Status RECRUITING

Clinical Trial Site

Sylmar, California, United States

Site Status RECRUITING

Clinical Trial Site

Colorado Springs, Colorado, United States

Site Status RECRUITING

Clinical Trial Site

Fort Collins, Colorado, United States

Site Status RECRUITING

Clinical Trial Site

New Haven, Connecticut, United States

Site Status RECRUITING

Clinical Trial Site

Washington D.C., District of Columbia, United States

Site Status RECRUITING

Clinical Trial Site

Clearwater, Florida, United States

Site Status RECRUITING

Clincal Trial Site

Gainesville, Florida, United States

Site Status RECRUITING

Clinical Trial Site

Jacksonville, Florida, United States

Site Status RECRUITING

Clinical Trial Site

Tampa, Florida, United States

Site Status RECRUITING

Clinical Trial Site

Augusta, Georgia, United States

Site Status RECRUITING

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Iowa City, Iowa, United States

Site Status RECRUITING

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Lexington, Kentucky, United States

Site Status RECRUITING

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Boston, Massachusetts, United States

Site Status RECRUITING

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Lansing, Michigan, United States

Site Status RECRUITING

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Columbia, Missouri, United States

Site Status RECRUITING

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New Hyde Park, New York, United States

Site Status RECRUITING

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Chapel Hill, North Carolina, United States

Site Status RECRUITING

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Charlotte, North Carolina, United States

Site Status RECRUITING

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Durham, North Carolina, United States

Site Status RECRUITING

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Dayton, Ohio, United States

Site Status RECRUITING

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Philadelphia, Pennsylvania, United States

Site Status RECRUITING

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Chattanooga, Tennessee, United States

Site Status RECRUITING

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Knoxville, Tennessee, United States

Site Status RECRUITING

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Dallas, Texas, United States

Site Status RECRUITING

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Houston, Texas, United States

Site Status RECRUITING

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Burlington, Vermont, United States

Site Status RECRUITING

Clinical Trial Site

Milwaukee, Wisconsin, United States

Site Status RECRUITING

Clinical Trial Site

Vienna, , Austria

Site Status RECRUITING

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Brampton, Ontario, Canada

Site Status RECRUITING

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London, Ontario, Canada

Site Status RECRUITING

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Montreal, Quebec, Canada

Site Status RECRUITING

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Chengdu, Sichuan, China

Site Status RECRUITING

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Beijing, , China

Site Status RECRUITING

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Changchun, , China

Site Status RECRUITING

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Chengdu, , China

Site Status RECRUITING

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Guangzhou, , China

Site Status RECRUITING

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Jinan, , China

Site Status RECRUITING

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Nanchang, , China

Site Status RECRUITING

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Qingdao, , China

Site Status RECRUITING

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Shijiazhuang, , China

Site Status RECRUITING

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Hanover, Hannover, Germany

Site Status RECRUITING

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Milan, , Italy

Site Status RECRUITING

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Naples, , Italy

Site Status RECRUITING

Clinical Trial Site

Abhā, , Saudi Arabia

Site Status RECRUITING

Clinical Trial Site

Jeddah, , Saudi Arabia

Site Status RECRUITING

Clinical Trial Site

Riyadh, , Saudi Arabia

Site Status RECRUITING

Countries

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United States Austria Canada China Germany Italy Saudi Arabia

Central Contacts

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Alexion Pharmaceuticals, Inc. (Sponsor)

Role: CONTACT

1-855-752-2356

Other Identifiers

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ALXN-MG-501

Identifier Type: -

Identifier Source: org_study_id

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