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

Last updated: February 13, 2026
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

  • Kepler Universitätsklinikum, Universitätsklinik für Neurologie, Med Campus III

    Linz 2772400, 4021
    Austria

    Active - Recruiting

  • UZ Leuven (University Hospitals Leuven)

    Leuven, 3000
    Belgium

    Site Not Available

  • UZ Leuven (University Hospitals Leuven)

    Leuven 2792482, 3000
    Belgium

    Active - Recruiting

  • Klinikum Altenburger Land GmbH

    Altenburg 2957773, 04600
    Germany

    Active - Recruiting

  • St. Josef-Hospital Klinikum der Ruhr Universitaet Bochum

    Bochum 2947416, 44791
    Germany

    Active - Recruiting

  • Klinikum Oberberg

    Gummersbach 2913761, 51643
    Germany

    Active - Recruiting

  • Klinikum Christophsbad

    Göppingen 2919054, 7303
    Germany

    Active - Recruiting

  • Georg-August-Universität Göttingen

    Göttingen 2918632, 37073
    Germany

    Active - Recruiting

  • Universitätsklinikum Jena

    Jena 2895044, 07747
    Germany

    Active - Recruiting

  • Universitätsklinikum Würzburg

    Würzburg 2805615, 97080
    Germany

    Active - Recruiting

  • Piazza OMS - Organizzazione Mondiale della Sanità

    Bergamo 3182164, 24127
    Italy

    Active - Recruiting

  • Ospedale Bellaria - Clinica Neurologica

    Bologna 3181928, 40139
    Italy

    Active - Recruiting

  • Azienda Ospedaliera di Rilievo Nazionale Cardarelli

    Napoli 9031661, 80131
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria Pisana

    Pisa 3170647, 56126
    Italy

    Active - Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma 8957247, 00168
    Italy

    Active - Recruiting

  • Hospital Universitari Vall d'Hebron, Unitat de Malalties Neuromusculars, Servei de Neurologia

    Barcelona 3128760, 08035
    Spain

    Active - Recruiting

  • Hospital Universitari de Bellvitge

    Barcelona 3128760, 08907
    Spain

    Active - Recruiting

  • Hospital Clinico Universitario San Carlos

    Madrid 3117735, 28040
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen Macarena

    Seville 2510911, 41009
    Spain

    Active - Recruiting

  • UCSF Medical Center - Helen Diller Family Comprehensive Cancer Center - Brain Tumor Center,

    San Francisco 5391959, California 5332921 94143
    United States

    Active - Recruiting

  • SFM Clinical Research, LLC

    Boca Raton, Florida 33487
    United States

    Site Not Available

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

    St. Petersburg, Florida 33705
    United States

    Site Not Available

  • SFM Clinical Research, LLC

    Boca Raton 4148411, Florida 4155751 33487
    United States

    Active - Recruiting

  • University of Florida College of Medicine Jacksonville

    Jacksonville Beach 4160023, Florida 4155751 32209
    United States

    Active - Recruiting

  • Medsol Clinical Research Center Inc

    Port Charlotte 4169130, Florida 4155751 33952
    United States

    Active - Recruiting

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

    St. Petersburg 4171563, Florida 4155751 33705
    United States

    Active - Recruiting

  • Prairie Education and Research Cooperative and HSHS Medical Group

    O'Fallon, Illinois 62701
    United States

    Site Not Available

  • Prairie Education and Research Cooperative and HSHS Medical Group

    O'Fallon 4245926, Illinois 4896861 62701
    United States

    Active - Recruiting

  • University of Iowa

    Iowa City 4862034, Iowa 4862182 52242
    United States

    Active - Recruiting

  • University of Kansas Medical Center

    Kansas City 4273837, Kansas 4273857 66160
    United States

    Active - Recruiting

  • Norton Neuroscience Institute

    Louisville, Kentucky 40241
    United States

    Site Not Available

  • Norton Neuroscience Institute

    Louisville 4299276, Kentucky 6254925 40241
    United States

    Active - Recruiting

  • Beth Israel Deaconess Medical Center

    Boston 4930956, Massachusetts 6254926 02215
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston 4930956, Massachusetts 6254926 02114
    United States

    Active - Recruiting

  • Henry Ford Health System

    Detroit 4990729, Michigan 5001836 48202
    United States

    Active - Recruiting

  • Oregon Health and Science University

    Portland 5746545, Oregon 5744337 97239
    United States

    Active - Recruiting

  • University of Colorado Hospital

    Portland 5746545, Oregon 5744337 97239
    United States

    Active - Recruiting

  • Medical University of South Carolina

    Charleston 4574324, South Carolina 4597040 29425
    United States

    Active - Recruiting

  • National Neuromuscular Research Institute

    Austin, Texas 78759
    United States

    Site Not Available

  • National Neuromuscular Research Institute

    Austin 4671654, Texas 4736286 78759
    United States

    Active - Recruiting

  • BCN Research, LLC - Gamma Therapeutic Center

    Greenfield 5255068, Wisconsin 5279468 53228
    United States

    Active - Recruiting

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