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RecruitingNCT04202341Updated Feb 18, 2026

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

An observational study in Generalized Myasthenia Gravis, sponsored by Alexion Pharmaceuticals, Inc.. Recruiting at 51 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-18.

Sponsored by Alexion Pharmaceuticals, Inc. · Observational

From the registry’s dates

  • Started Dec 2019; still recruiting 6 years 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
18 Years and older
Sex
All
01

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®).

Read the 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.

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Conditions studied

  • Generalized Myasthenia Gravis

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Keywords

  • gMG
  • Soliris
  • Ultomiris
  • Alexion C5 Inhibition Therapy
  • Alexion C5IT
  • Patient Registry
  • Generalized Myasthenia Gravis
  • Alexion Registry
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In context

Myasthenia Gravis

324 studies on the registry are indexed under Myasthenia Gravis; 146 are open to participants now.

This study's planned enrollment of 500 is above the median of 140 across 104 observational studies indexed under Myasthenia Gravis.

Browse Myasthenia Gravis studies →

Lead sponsor

Alexion Pharmaceuticals, Inc. is the lead sponsor of 249 studies on the registry; 25 are open to participants now.

Of its 98 completed or terminated interventional studies of FDA-regulated products, 70 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

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

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.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Approximately 5 years from enrollment

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Study locations

51 of 51 sites recruiting
  • Clinical Trial Site
    Birmingham, Alabama 35294, United States
    Recruiting
  • Clinical Trial Site
    Scottsdale, Arizona 85251, United States
    Recruiting
  • Clinical Trial Site
    Fresno, California 93710, United States
    Recruiting
  • Clinical Trial Site
    Orange, California 92868, United States
    Recruiting
  • Clinical Trial Site
    Rancho Mirage, California 92270, United States
    Recruiting
  • Clinical Trial Site
    Sylmar, California 91342, United States
    Recruiting
  • Clinical Trial Site
    Colorado Springs, Colorado 80907, United States
    Recruiting
  • Clinical Trial Site
    Fort Collins, Colorado 80528, United States
    Recruiting
  • Clinical Trial Site
    New Haven, Connecticut 06520, United States
    Recruiting
  • Clinical Trial Site
    Washington D.C., District of Columbia 10010, United States
    Recruiting
  • Clinical Trial Site
    Clearwater, Florida 33761, United States
    Recruiting
  • Clincal Trial Site
    Gainesville, Florida 32608, United States
    Recruiting
  • Clinical Trial Site
    Jacksonville, Florida 32209, United States
    Recruiting
  • Clinical Trial Site
    Tampa, Florida 33612, United States
    Recruiting
  • Clinical Trial Site
    Augusta, Georgia 30912, United States
    Recruiting
  • Clinical Trial Site
    Iowa City, Iowa 52242, United States
    Recruiting
  • Clinical Trial Site
    Lexington, Kentucky 40503, United States
    Recruiting
  • Clinical Trial Site
    Boston, Massachusetts 02215, United States
    Recruiting
  • Clinical Trial Site
    Lansing, Michigan 48824, United States
    Recruiting
  • Clinical Trial Site
    Columbia, Missouri 65212, United States
    Recruiting
  • Clinical Trial Site
    New Hyde Park, New York 11042, United States
    Recruiting
  • Clinical Trial Site
    Chapel Hill, North Carolina 27599, United States
    Recruiting
  • Clinical Trial Site
    Charlotte, North Carolina 28207, United States
    Recruiting
  • Clinical Trial Site
    Durham, North Carolina 27705, United States
    Recruiting
  • Clinical Trial Site
    Dayton, Ohio 45459, United States
    Recruiting
  • Clinical Trial Site
    Philadelphia, Pennsylvania 19104, United States
    Recruiting
  • Clinical Trial Site
    Chattanooga, Tennessee 37403, United States
    Recruiting
  • Clinical Trial Site
    Knoxville, Tennessee 37920, United States
    Recruiting
  • Clinical Trial Site
    Dallas, Texas 75206, United States
    Recruiting
  • Clinical Trial Site
    Houston, Texas 77030, United States
    Recruiting
  • Clinical Trial Site
    Burlington, Vermont 05401, United States
    Recruiting
  • Clinical Trial Site
    Milwaukee, Wisconsin 53215, United States
    Recruiting
  • Clinical Trial Site
    Vienna, 1090, Austria
    Recruiting
  • Clinical Trial Site
    Brampton, Ontario L6R 3J7, Canada
    Recruiting
  • Clinical Trial Site
    London, Ontario N6A 5A5, Canada
    Recruiting
  • Clinical Trial Site
    Montreal, Quebec H2X 3E4, Canada
    Recruiting
  • Clinical Trial Site
    Chengdu, Sichuan 610041, China
    Recruiting
  • Clinical Trial Site
    Beijing, 100730, China
    Recruiting
  • Clinical Trial Site
    Changchun, 130021, China
    Recruiting
  • Clinical Trial Site
    Chengdu, 610072, China
    Recruiting
  • Clinical Trial Site
    Guangzhou, 510080, China
    Recruiting
  • Clinical Trial Site
    Jinan, 250021, China
    Recruiting
  • Clinical Trial Site
    Nanchang, 330006, China
    Recruiting
  • Clinical Trial Site
    Qingdao, 266003, China
    Recruiting
  • Clinical Trial Site
    Shijiazhuang, 050000, China
    Recruiting
  • Clinical Trial Site
    Hanover, Hannover 30625, Germany
    Recruiting
  • Clinical Trial Site
    Milan, 20133, Italy
    Recruiting
  • Clinical Trial Site
    Naples, 80138, Italy
    Recruiting
  • Clinical Trial Site
    Abhā, 62523, Saudi Arabia
    Recruiting
  • Clinical Trial Site
    Jeddah, 22384, Saudi Arabia
    Recruiting
  • Clinical Trial Site
    Riyadh, 14611, Saudi Arabia
    Recruiting
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References and documents

Publications

  • Howard JF Jr, Dodig D, Zeinali L, Macwan SP, Yegin A, Pulley MT, Rodrigues E, Narayanaswami P. First analysis of the Myasthenia Gravis SPOTLIGHT Registry: outcomes with eculizumab and ravulizumab. J Neurol Sci. 2025 Sep 15;476:123628. doi: 10.1016/j.jns.2025.123628. Epub 2025 Jul 16. PubMed 40812271 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04202341
Lead sponsor
Alexion Pharmaceuticals, Inc.
Responsible party
Sponsor
First posted
Dec 17, 2019
Start date
Dec 2, 2019
Primary completion
Oct 1, 2029 (estimated)
Completion
Oct 1, 2029 (estimated)
Last update
Feb 18, 2026

Study contacts

Alexion Pharmaceuticals, Inc. (Sponsor)
Contact
clinicaltrials@alexion.com
1-855-752-2356

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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