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

Study at a glance

From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

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

ClinicalTrials.gov ID

NCT04202341

Acronym / sponsor ID

ALXN-MG-501

Conditions

Generalized Myasthenia Gravis

Keywords

gMG, Soliris, Ultomiris, Alexion C5 Inhibition Therapy, Alexion C5IT, Patient Registry, Generalized Myasthenia Gravis, Alexion Registry

Study type

Observational

Recruitment status

Recruiting

Enrolment

500 participants (estimated)

Lead sponsor

Alexion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)

Study start

2 Dec 2019 (actual)

Primary completion

1 Oct 2029 (estimated)

Study completion

1 Oct 2029 (estimated)

First posted

17 Dec 2019 (actual)

Results

Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model

Cohort

Time perspective

Prospective

Target follow-up

5 Years

Who may qualify

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
• Derived from this study: PubMed 40812271Howard 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

51 sites in 7 countries: see every site and its status.