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

NCT04202341 · tracked via the Priya Life Science Canada tracker

Sponsor

Alexion Pharmaceuticals, Inc

Phase

Observational

Started

2019-12-02

Last updated

2026-02-18

Condition(s) studied

Generalized Myasthenia Gravis

Study 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®).

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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with Alexion C5IT at the time of enrollment, including patients previously treated with Soliris or Ultomiris and withdrawn from treatment. 2.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

Primary outcome measure(s)

Change in Myasthenia Gravis Activities of Daily Living (MG-ADL) Score — 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.

Trial sites (51)

Facility	City	Region	Status
Clinical Trial Site	Birmingham	Alabama	Recruiting
Clinical Trial Site	Scottsdale	Arizona	Recruiting
Clinical Trial Site	Fresno	California	Recruiting
Clinical Trial Site	Orange	California	Recruiting
Clinical Trial Site	Rancho Mirage	California	Recruiting
Clinical Trial Site	Sylmar	California	Recruiting
Clinical Trial Site	Colorado Springs	Colorado	Recruiting
Clinical Trial Site	Fort Collins	Colorado	Recruiting
Clinical Trial Site	New Haven	Connecticut	Recruiting
Clinical Trial Site	Washington D.C.	District of Columbia	Recruiting
Clinical Trial Site	Clearwater	Florida	Recruiting
Clincal Trial Site	Gainesville	Florida	Recruiting
Clinical Trial Site	Jacksonville	Florida	Recruiting
Clinical Trial Site	Tampa	Florida	Recruiting
Clinical Trial Site	Augusta	Georgia	Recruiting
Clinical Trial Site	Iowa City	Iowa	Recruiting
Clinical Trial Site	Lexington	Kentucky	Recruiting
Clinical Trial Site	Boston	Massachusetts	Recruiting
Clinical Trial Site	Lansing	Michigan	Recruiting
Clinical Trial Site	Columbia	Missouri	Recruiting
Clinical Trial Site	New Hyde Park	New York	Recruiting
Clinical Trial Site	Chapel Hill	North Carolina	Recruiting
Clinical Trial Site	Charlotte	North Carolina	Recruiting
Clinical Trial Site	Durham	North Carolina	Recruiting
Clinical Trial Site	Dayton	Ohio	Recruiting
Clinical Trial Site	Philadelphia	Pennsylvania	Recruiting
Clinical Trial Site	Chattanooga	Tennessee	Recruiting
Clinical Trial Site	Knoxville	Tennessee	Recruiting
Clinical Trial Site	Dallas	Texas	Recruiting
Clinical Trial Site	Houston	Texas	Recruiting
Clinical Trial Site	Burlington	Vermont	Recruiting
Clinical Trial Site	Milwaukee	Wisconsin	Recruiting
Clinical Trial Site	Vienna	Austria	Recruiting
Clinical Trial Site	Brampton	Ontario	Recruiting
Clinical Trial Site	London	Ontario	Recruiting
Clinical Trial Site	Montreal	Quebec	Recruiting
Clinical Trial Site	Chengdu	Sichuan	Recruiting
Clinical Trial Site	Beijing	China	Recruiting
Clinical Trial Site	Changchun	China	Recruiting
Clinical Trial Site	Chengdu	China	Recruiting

+ 11 more sites — see the full list on the official registry below.

More Alexion Pharmaceuticals, Inc. trials in Canada

Study of Ravulizumab in Immunoglobulin A Nephropathy (IgAN) Active, not recruiting

Safety and Efficacy of ALXN1720 in Adults With Generalized Myasthenia Gravis Active, not recruiting

Phase 2 Study of ALXN2030 in Patients With Antibody-Mediated Rejection After Kidney Transplantation Active, not recruiting

Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab Administered Intravenously in Adult Participants at High Risk of Delayed Graft Function After Kidney Transplantation Recruiting

Registry of Patients With Hypophosphatasia Enrolling by invitation

Other trials for the same condition

Safety and Efficacy of ALXN1720 in Adults With Generalized Myasthenia Gravis Active, not recruiting

A Study of Efgartigimod PH20 SC in Children Between 2 and Less Than 18 Years of Age With Generalized Myasthenia Gravis Recruiting

Evaluating Long-term Safety of Efgartigimod Administered Intravenously and Efgartigimod PH20 Administered Subcutaneously in Children With Generalized Myasthenia Gravis Enrolling by invitation

A Phase 3 Study to Evaluate the Efficacy and Safety of Efgartigimod IV in Patients With Acetylcholine Receptor Binding Antibody Seronegative Generalized Myasthenia Gravis Active, not recruiting

A Study of Telitacicept for the Treatment of Generalized Myasthenia Gravis (UPSTREAM MG) Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04202341 on ClinicalTrials.gov ↗ ← All trials in Canada