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

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ClinicalTrials.gov Identifier: NCT04202341
Recruitment Status : Recruiting
First Posted : December 17, 2019
Last Update Posted : March 3, 2023
Sponsor:
Information provided by (Responsible Party):
Alexion

Study Description
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Brief 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®).

Condition or disease
Generalized Myasthenia Gravis

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.
Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Long-Term, Observational, Global Registry of Patients With Generalized Myasthenia Gravis Who Have Received Treatment With Complement C5 Inhibition Therapies (C5ITs)
Actual Study Start Date : December 11, 2019
Estimated Primary Completion Date : November 30, 2024
Estimated Study Completion Date : November 30, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Change in Myasthenia Gravis Activities of Daily Living (MG-ADL) Score [ Time Frame: Approximately 5 years from enrollment ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants with a diagnosis of gMG who are treated with Alexion C5IT at the time of enrollment, or have ever been treated with Alexion C5IT prior to enrollment, and meet the inclusion criteria and exclusion criteria are eligible for registry participation.
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04202341


Contacts
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Contact: Alexion Pharmaceuticals Inc. 855-752-2356 clinicaltrials@alexion.com

Locations
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United States, Alabama
Clinical Trial Site Recruiting
Birmingham, Alabama, United States, 35294
United States, Arizona
Clinical Trial Site Recruiting
Phoenix, Arizona, United States, 85001
United States, California
Clinical Trial Site Recruiting
Fresno, California, United States, 93710
Clinical Trial Site Recruiting
Rancho Mirage, California, United States, 92270
Clinical Trial Site Recruiting
Sylmar, California, United States, 91342
United States, Colorado
Clinical Trial Site Recruiting
Colorado Springs, Colorado, United States, 80907
Clinical Trial Site Recruiting
Fort Collins, Colorado, United States, 80528
United States, Connecticut
Clinical Trial Site Recruiting
New Haven, Connecticut, United States, 06520
United States, Florida
Clinical Trial Site Recruiting
Clearwater, Florida, United States, 33761
Clincal Trial Site Recruiting
Gainesville, Florida, United States, 32608
Clinical Trial Site Recruiting
Tampa, Florida, United States, 33620
United States, Georgia
Clinical Trial Site Recruiting
Augusta, Georgia, United States, 30912
United States, Illinois
Clinical Trial Site Recruiting
Lake Barrington, Illinois, United States, 60010
United States, Iowa
Clinical Trial Site Recruiting
Iowa City, Iowa, United States, 52242
United States, Kentucky
Clinical Trial Site Recruiting
Lexington, Kentucky, United States, 40503
United States, Massachusetts
Clinical Trial Site Recruiting
Boston, Massachusetts, United States, 02215
United States, Michigan
Clinical Trial Site Recruiting
Lansing, Michigan, United States, 48824
United States, Nevada
Clinical Trial Site Recruiting
Las Vegas, Nevada, United States, 89145
United States, New York
Clinical Trial Site Recruiting
New Hyde Park, New York, United States, 11042
United States, North Carolina
Clinical Trial Site Recruiting
Chapel Hill, North Carolina, United States, 27514
Clinical Trial Site Recruiting
Durham, North Carolina, United States, 27710
United States, Ohio
Clinical Trial Site Recruiting
Dayton, Ohio, United States, 45459
United States, Pennsylvania
Clinical Trial Site Recruiting
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Clinical Trial Site Recruiting
Dallas, Texas, United States, 75206
Clinical Trial Site Recruiting
Houston, Texas, United States, 77001
United States, Vermont
Clinical Trial Site Recruiting
Burlington, Vermont, United States, 05401
United States, Wisconsin
Clinical Trial Site Recruiting
Milwaukee, Wisconsin, United States, 53215
Sponsors and Collaborators
Alexion
More Information
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Responsible Party: Alexion
ClinicalTrials.gov Identifier: NCT04202341    
Other Study ID Numbers: ALXN-MG-501
First Posted: December 17, 2019    Key Record Dates
Last Update Posted: March 3, 2023
Last Verified: March 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alexion:
gMG
Soliris
Ultomiris
Alexion C5 Inhibition Therapy
 Alexion C5IT
Patient Registry
Generalized Myasthenia Gravis
Alexion Registry
Additional relevant MeSH terms:
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Myasthenia Gravis
Muscle Weakness
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes
Paraneoplastic Syndromes, Nervous System
Nervous System Neoplasms
 Neoplasms by Site
Neoplasms
Paraneoplastic Syndromes
Autoimmune Diseases of the Nervous System
Neurodegenerative Diseases
Neuromuscular Junction Diseases
Neuromuscular Diseases
Autoimmune Diseases
Immune System Diseases