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

Part of paid clinical trials in San Francisco, California.

Sponsor
argenx
Study ID
NCT06298565
Status
Recruiting
Apply to this trial

Conditions

  • Myasthenia Gravis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • efgartigimod — BIOLOGICAL
    efgartigimod

Study Details

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.

Key Dates

Start date
Nov 4, 2024
Status verified
Feb 2026
Primary completion
Jun 30, 2034
Completion
Jun 30, 2034

Study Design

Enrollment
680 participants (estimated)

Arms

  • Arm: efgartigimod cohort
    patients treated with efgartigimod
  • Arm: non-efgartigimod cohort
    patient treated with other MG medication

Primary Outcome Measure

The overall long-term safety of efgartigimod including the occurrence of serious infections in generalized myasthenia gravis (gMG) patients treated with efgartigimod compared to gMG patients not exposed to efgartigimod [ Time Frame: up to 10 years ]

Central Contacts

Locations (17)

FacilityCityStateZIPSite coordinators
UCSF Medical Center - Helen Diller Family Comprehensive Cancer Center - Brain Tumor Center,San FranciscoCalifornia94143
Min Kang, MD
[email protected]
857-350-4834
SFM Clinical Research, LLCBoca RatonFlorida33487
Marc Feinberg, MD
[email protected]
857-350-4834
University of Florida College of Medicine JacksonvilleJacksonville BeachFlorida32209
Michael Pulley, MD
[email protected]
857-350-4834
Medsol Clinical Research Center IncPort CharlotteFlorida33952
George Li, MD
[email protected]
857-350-4834
BayCare Health System, Inc. St Anthony's HospitalSt. PetersburgFlorida33705
Michael Rosario-Prieto, MD
[email protected]
857-350-4834
Prairie Education and Research Cooperative and HSHS Medical GroupO'FallonIllinois62701
Raghav Govindarajan, MD
[email protected]
857-350-4834
University of IowaIowa CityIowa52242
Christopher Nance, MD
[email protected]
857-350-4834
University of Kansas Medical CenterKansas CityKansas66160
Mamatha Pasnoor, MD
[email protected]
857-350-4834
Norton Neuroscience InstituteLouisvilleKentucky40241
Richard Lewis, MD
[email protected]
857-350-4834
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Pushpa Narayanaswami, MD
[email protected]
857-350-4834
Massachusetts General HospitalBostonMassachusetts02114
Amanda Guidon, MD
[email protected]
857-350-4834
Henry Ford Health SystemDetroitMichigan48202
Kavita Grover, MD
[email protected]
857-350-4834
Oregon Health and Science UniversityPortlandOregon97239
Nizar Chahin, MD
[email protected]
857-350-4834
University of Colorado HospitalPortlandOregon97239
Thomas Ragole, MD
[email protected]
857-350-4834
Medical University of South CarolinaCharlestonSouth Carolina29425
Katherine Ruzhansky, MD
[email protected]
857-350-4834
National Neuromuscular Research InstituteAustinTexas78759
Yessar Hussain, MD
[email protected]
857-350-4834
BCN Research, LLC - Gamma Therapeutic CenterGreenfieldWisconsin53228
Bhupendra Khatri, MD
[email protected]
857-350-4834

Find similar trials in San Francisco, CA

By research site
UCSF Medical Center - Helen Diller Family Comprehensive Cancer Center - Brain Tumor Center· San Francisco, CASFM Clinical Research, LLC· Boca Raton, FLUniversity of Florida College of Medicine Jacksonville· Jacksonville Beach, FLMedsol Clinical Research Center Inc· Port Charlotte, FLBayCare Health System, Inc. St Anthony's Hospital· St. Petersburg, FLPrairie Education and Research Cooperative and HSHS Medical Group· O'Fallon, IL

Related Studies