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NCT04202341 Clinical Trial

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

Generalized Myasthenia Gravis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04202341
Other study ID # ALXN-MG-501
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 2, 2019
Est. completion date December 31, 2029

Study information
Verified date March 2024
Source Alexion Pharmaceuticals, Inc.
Contact Alexion Pharmaceuticals, Inc. (Sponsor)
Phone 1-855-752-2356
Email clinicaltrials@alexion.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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®).

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 500
Est. completion date December 31, 2029
Est. primary completion date December 31, 2029
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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with Alexion C5IT at the time of enrollment, including patients previously treated with Soliris or Ultomiris and withdrawn from treatment. 2.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.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Clinical Trial Site Augusta Georgia
United States Clinical Trial Site Birmingham Alabama
United States Clinical Trial Site Boston Massachusetts
United States Clinical Trial Site Burlington Vermont
United States Clinical Trial Site Chapel Hill North Carolina
United States Clinical Trial Site Clearwater Florida
United States Clinical Trial Site Colorado Springs Colorado
United States Clinical Trial Site Dallas Texas
United States Clinical Trial Site Dayton Ohio
United States Clinical Trial Site Durham North Carolina
United States Clinical Trial Site Fort Collins Colorado
United States Clinical Trial Site Fresno California
United States Clincal Trial Site Gainesville Florida
United States Clinical Trial Site Houston Texas
United States Clinical Trial Site Iowa City Iowa
United States Clinical Trial Site Lake Barrington Illinois
United States Clinical Trial Site Lansing Michigan
United States Clinical Trial Site Las Vegas Nevada
United States Clinical Trial Site Lexington Kentucky
United States Clinical Trial Site Milwaukee Wisconsin
United States Clinical Trial Site New Haven Connecticut
United States Clinical Trial Site New Hyde Park New York
United States Clinical Trial Site Philadelphia Pennsylvania
United States Clinical Trial Site Phoenix Arizona
United States Clinical Trial Site Rancho Mirage California
United States Clinical Trial Site Sylmar California
United States Clinical Trial Site Tampa Florida

Sponsors (1)
Lead Sponsor Collaborator
Alexion Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Myasthenia Gravis Activities of Daily Living (MG-ADL) Score The MG-ADL is an eight-item patient-reported outcome measure assessing MG symptoms and functional activities related to activities of daily living.48 Each of the items is scored from 0 (normal) to 3 (most severe), providing a total MG-ADL score ranging from 0 to 24, where higher scores indicate greater severity of symptoms. Approximately 5 years from enrollment
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