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Clinical Trials in Italy / NCT04202341
Recruiting Observational

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

NCT04202341 · tracked via the Priya Life Science Italy 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
No
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with Alexion C5IT at the time of enrollment, including patients previously treated with Soliris or Ultomiris and withdrawn from treatment. 2.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)

FacilityCityRegionStatus
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 Italy

Study of ALXN1920 in Adult Participants With Primary Membranous Nephropathy (PMN) Recruiting
Safety and Efficacy of ALXN1720 in Adults With Generalized Myasthenia Gravis Active, not recruiting
Atypical Hemolytic-Uremic Syndrome (aHUS) Registry Recruiting
Study of ALXN2220 Versus Placebo in Adults With ATTR-CM Active, not recruiting
Registry of Patients With Hypophosphatasia Enrolling by invitation

Other trials for the same condition

A Study to Evaluate Subcutaneous Zilucoplan in Pediatric Participants With Generalized Myasthenia Gravis Recruiting
Safety and Efficacy of ALXN1720 in Adults With Generalized Myasthenia Gravis Active, not recruiting
A Study of Rozanolixizumab in Pediatric Study Participants With Moderate to Severe Generalized Myasthenia Gravis Active, not recruiting
ADAPT Forward - Master Protocol of a Platform Study to Evaluate the Safety and Efficacy of Multiple Regimens in Participants With Myasthenia Gravis Recruiting
A Study to Test How Safe Pozelimab and Cemdisiran Combination Therapy and Cemdisiran Alone Are and How Well They Work in Adult Patients With Generalized Myasthenia Gravis Active, not 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 Italy