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

NCT ID: NCT06298565

Last Updated: 2025-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

680 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-04

Study Completion Date

2034-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Myasthenia Gravis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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efgartigimod cohort

patients treated with efgartigimod

efgartigimod

Intervention Type BIOLOGICAL

efgartigimod

non-efgartigimod cohort

patient treated with other MG medication

No interventions assigned to this group

Interventions

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efgartigimod

efgartigimod

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Patients diagnosed with gMG who are expected to start commercial efgartigimod at enrolment or who are within their first cycle of efgartigimod at enrolment or Patients diagnosed with gMG who have not been exposed to efgartigimod and for whom it is not planned to start treatment with efgartigimod at enrolment
* Have provided appropriate written informed consent

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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argenx

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

San Francisco, California, United States

Site Status RECRUITING

SFM Clinical Research, LLC

Boca Raton, Florida, United States

Site Status RECRUITING

University of Florida College of Medicine Jacksonville

Jacksonville Beach, Florida, United States

Site Status RECRUITING

Medsol Clinical Research Center Inc

Port Charlotte, Florida, United States

Site Status RECRUITING

BayCare Health System, Inc. St Anthony's Hospital

St. Petersburg, Florida, United States

Site Status RECRUITING

Prairie Education and Research Cooperative and HSHS Medical Group

O'Fallon, Illinois, United States

Site Status RECRUITING

University of Iowa

Iowa City, Iowa, United States

Site Status RECRUITING

University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status RECRUITING

Norton Neuroscience Institute

Louisville, Kentucky, United States

Site Status RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status RECRUITING

Henry Ford Health System

Detroit, Michigan, United States

Site Status RECRUITING

Oregon Health and Science University

Portland, Oregon, United States

Site Status RECRUITING

University of Colorado Hospital

Portland, Oregon, United States

Site Status RECRUITING

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status RECRUITING

National Neuromuscular Research Institute

Austin, Texas, United States

Site Status RECRUITING

BCN Research, LLC - Gamma Therapeutic Center

Greenfield, Wisconsin, United States

Site Status RECRUITING

Kepler Universitätsklinikum, Universitätsklinik für Neurologie, Med Campus III

Linz, , Austria

Site Status RECRUITING

UZ Leuven (University Hospitals Leuven)

Leuven, , Belgium

Site Status RECRUITING

Klinikum Altenburger Land GmbH

Altenburg, , Germany

Site Status RECRUITING

St. Josef-Hospital Klinikum der Ruhr Universitaet Bochum

Bochum, , Germany

Site Status RECRUITING

Klinikum Christophsbad

Göppingen, , Germany

Site Status RECRUITING

Georg-August-Universität Göttingen

Göttingen, , Germany

Site Status RECRUITING

Klinikum Oberberg

Gummersbach, , Germany

Site Status RECRUITING

Universitätsklinikum Jena

Jena, , Germany

Site Status RECRUITING

Universitätsklinikum Würzburg

Würzburg, , Germany

Site Status RECRUITING

Piazza OMS - Organizzazione Mondiale della Sanità

Bergamo, , Italy

Site Status RECRUITING

Ospedale Bellaria - Clinica Neurologica

Bologna, , Italy

Site Status RECRUITING

Azienda Ospedaliera di Rilievo Nazionale Cardarelli

Napoli, , Italy

Site Status RECRUITING

Azienda Ospedaliero Universitaria Pisana

Pisa, , Italy

Site Status RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, , Italy

Site Status RECRUITING

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

Barcelona, , Spain

Site Status RECRUITING

Hospital Universitari de Bellvitge

Barcelona, , Spain

Site Status RECRUITING

Hospital Clinico Universitario San Carlos

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario Virgen Macarena

Seville, , Spain

Site Status RECRUITING

Countries

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United States Austria Belgium Germany Italy Spain

Central Contacts

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Sabine Coppieters, MD

Role: CONTACT

857-350-4834

Facility Contacts

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Min Kang, MD

Role: primary

857-350-4834

Marc Feinberg, MD

Role: primary

857-350-4834

Michael Pulley, MD

Role: primary

857-350-4834

George Li, MD

Role: primary

857-350-4834

Michael Rosario-Prieto, MD

Role: primary

857-350-4834

Raghav Govindarajan, MD

Role: primary

857-350-4834

Christopher Nance, MD

Role: primary

857-350-4834

Mamatha Pasnoor, MD

Role: primary

857-350-4834

Richard Lewis, MD

Role: primary

857-350-4834

Amanda Guidon, MD

Role: primary

857-350-4834

Pushpa Narayanaswami, MD

Role: primary

857-350-4834

Kavita Grover, MD

Role: primary

857-350-4834

Nizar Chahin, MD

Role: primary

857-350-4834

Thomas Ragole, MD

Role: primary

857-350-4834

Katherine Ruzhansky, MD

Role: primary

857-350-4834

Yessar Hussain, MD

Role: primary

857-350-4834

Bhupendra Khatri, MD

Role: primary

857-350-4834

Lukas Kellermair, MD

Role: primary

857-350-4834

Kristl Claeys, MD

Role: primary

857-350-4834

Jörg Berrouschot, MD

Role: primary

857-350-4834

Christiane Schneider-Gold, MD

Role: primary

857-350-4834

Katharina Althaus, MD

Role: primary

857-350-4834

Jana Zschüntzsch, MD

Role: primary

857-350-4834

Franz Blaes, MD

Role: primary

857-350-4834

Annekathrin Rödiger, MD

Role: primary

857-350-4834

Axel Haarmann, MD

Role: primary

857-350-4834

Manlio Sgarzi, MD

Role: primary

857-350-4834

Maria Pia Giannoccaro, MD

Role: primary

857-350-4834

Francesco Habetswallner, MD

Role: primary

857-350-4834

Michelangelo Maestri Tassoni, MD

Role: primary

857-350-4834

Raffaele Iorio, MD

Role: primary

857-350-4834

Raul Juntas Morales, MD

Role: primary

857-350-4834

Carlos Casasnovas, MD

Role: primary

857-350-4834

Lucia Galán Dávila, MD

Role: primary

857-350-4834

Eva Maria Martinez Fernández, MD

Role: primary

857-350-4834

Other Identifiers

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ARGX-113-PASS-2208

Identifier Type: -

Identifier Source: org_study_id

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