Recruiting

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

Sponsor:

argenx

Code:

NCT06298565

Conditions

Myasthenia Gravis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

efgartigimod

Study Details

Brief 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.

Conditions

Myasthenia Gravis

Study ID

NCT06298565

Start date

Nov 4, 2024

Status verified date

Feb, 2026

Completion date

Jun, 2034

Anticipated

Primary completion date

Jun, 2034

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

680 participants

Anticipated

Interventions and Outcome Measures

Arms

efgartigimod cohort

patients treated with efgartigimod

non-efgartigimod cohort

patient treated with other MG medication

Interventions

efgartigimod

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 and Locations

Central contacts

Sabine Coppieters, MD

857-350-4834 Clinicaltrials@argenx.com

Locations

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

Recruiting

San Francisco, California, United States, 94143

Contacts

Min Kang, MD

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

Study Details

Eligibility Criteria

Study Design

Interventions and Outcome Measures

Central Contacts and Locations

More Information