A Non-interventional, Post-authorisation Safety Study of Patients Treated With Efgartigimod Alfa

Last updated: March 31, 2025
Sponsor: argenx
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neuropathy

Polymyositis (Inflammatory Muscle Disease)

Treatment

efgartigimod

Clinical Study ID

NCT06298565
ARGX-113-PASS-2208
  • Ages > 18
  • All Genders

Study Summary

This is a non-interventional, prospective, post authorization safety study. Patients with gMG who are expected to start treatment with efgartigimod at enrolment or are within their first cycle of efgartigimod at enrolment will be eligible to enroll into the efgartigimod cohort. Patients with gMG who have not been exposed to efgartigimod and for whom it is not planned to start treatment with efgartigimod at enrolment will be eligible to enroll into the non-efgartigimod cohort.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients diagnosed with gMG who are expected to start commercial efgartigimod atenrolment or who are within their first cycle of efgartigimod at enrolment orPatients diagnosed with gMG who have not been exposed to efgartigimod and for whomit is not planned to start treatment with efgartigimod at enrolment

  • Have provided appropriate written informed consent

Exclusion

Exclusion Criteria:

  • None

Study Design

Total Participants: 680
Treatment Group(s): 1
Primary Treatment: efgartigimod
Phase:
Study Start date:
November 04, 2024
Estimated Completion Date:
June 30, 2034

Connect with a study center

  • UZ Leuven (University Hospitals Leuven)

    Leuven, 3000
    Belgium

    Active - Recruiting

  • SFM Clinical Research, LLC

    Boca Raton, Florida 33487
    United States

    Active - Recruiting

  • BayCare Health System, Inc. St Anthony's Hospital

    St. Petersburg, Florida 33705
    United States

    Active - Recruiting

  • Prairie Education and Research Cooperative and HSHS Medical Group

    O'Fallon, Illinois 62701
    United States

    Active - Recruiting

  • Norton Neuroscience Institute

    Louisville, Kentucky 40241
    United States

    Active - Recruiting

  • National Neuromuscular Research Institute

    Austin, Texas 78759
    United States

    Active - Recruiting

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