Neoplasms

Nervous System Diseases

Immune System Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Myasthenia Gravis

Syndrome

Paraneoplastic Syndromes

Paraneoplastic Syndromes, Nervous System

Nervous System Neoplasms

Autoimmune Diseases

Autoimmune Diseases of the Nervous System

Neurodegenerative Diseases

Neuromuscular Junction Diseases

Neuromuscular Diseases

efgartigimod

Sabine Coppieters, MD

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.

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

argenx

Musculoskeletal Diseases

Asthenia

Muscle Weakness

Paresis

Muscular Diseases

Neuromuscular Manifestations

Neurologic Manifestations

This expanded access protocol applies to patients with gMG who are not enrolled in an ongoing clinical trial. The aim of the trial is to provide patients with generalized myasthenia gravis (gMG), who are ineligible to participate in a clinical trial, access to efgartigimod treatment before regulatory approval.

There are country-specific protocols and also individual use EAP. Recruitment for the treatment protocol in US is now closed (ARGX-113-EAP-2101).

Efgartigimod Expanded Access for Generalized Myasthenia Gravis

An Expanded Access Program for Efgartigimod Treatment in Patients With Generalized Myasthenia Gravis

woman is no longer pregnant at time of study enrollment but was exposed to efgartigimod any time within 25 days prior to conception or any time during pregnancy

woman is pregnant or breastfeeding at time of study enrollment.

Efgartigimod

This is a multi-country, prospective safety study of pregnant women exposed to efgartigimod any time within 25 days prior to conception or any time during pregnancy. Women exposed to efgartigimod only during breastfeeding will also be eligible to enroll. Background rates of major congenital malformations (MCMs) will be obtained from populations within the same countries/regions as the countries/regions in which the VYVGART IV or SC-exposed pregnancies were reported.

A Worldwide Pregnancy Safety Study to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to Efgartigimod During Pregnancy and/or Breastfeeding.

A Worldwide Pregnancy Safety Study To Assess Maternal, Fetal, And Infant Outcomes Following Exposure To Efgartigimod During Pregnancy And/Or Breastfeeding

Pregnancy outcomes: Spontaneous abortion; Elective or therapeutic abortion; Fetal death/stillbirth ; Molar or ectopic pregnancy; Live birth (Preterm delivery; Fullterm delivery)

Congenital malformations (CDC 2020b) identified in the developing fetus, neonate, or infant: Major congenital malformations (MCMs); Minor congenital malformations

Other events of interest identified in the developing neonate and infant (Hospitalizations for serious illness; Potential adverse reactions to medications; Growth and development milestones as described by the Centers for Disease Control and Prevention or other accepted standard assessments; Infant developmental deficiency; Postnatal growth deficiency or failure to thrive (FTT); Neonatal and infant mortality; Infections; Transient neonatal myasthenia; Vaccination and vaccine reactions

Maternal complications of pregnancy, including but not limited to: Premature rupture of membranes (PROM); Preterm PROM (PPROM); Pre-eclampsia; Gestational hypertension; Eclampsia; Proteinuria; Gestational diabetes; Intrauterine growth restriction (IUGR); Polyhdramnios

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Non-interventional, Post-authorisation Safety Study of Patients Treated With Efgartigimod Alfa	NCT06298565	Myasthenia Grav...	efgartigimod	18 Years -	argenx
Efgartigimod Expanded Access for Generalized Myasthenia Gravis	NCT04777734	Generalized Mya...	efgartigimod	18 Years -	argenx
A Worldwide Pregnancy Safety Study to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to Efgartigimod During Pregnancy and/or Breastfeeding.	NCT06299748	Myasthenia Grav...	Efgartigimod	18 Years -	argenx

Spots Global Cancer Trial Database for efgartigimod

Every month we try and update this database with for efgartigimod cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.