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

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Biological
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Florida
SFM Clinical Research, LLC
RECRUITING
Boca Raton
BayCare Health System, Inc. St Anthony's Hospital
RECRUITING
St. Petersburg
Illinois
Prairie Education and Research Cooperative and HSHS Medical Group
RECRUITING
O'fallon
Kentucky
Norton Neuroscience Institute
RECRUITING
Louisville
Texas
National Neuromuscular Research Institute
RECRUITING
Austin
Other Locations
Belgium
UZ Leuven (University Hospitals Leuven)
RECRUITING
Leuven
Contact Information
Primary
Sabine Coppieters, MD
Clinicaltrials@argenx.com
857-350-4834
Time Frame
Start Date: 2024-11-04
Estimated Completion Date: 2034-06
Participants
Target number of participants: 680
Treatments
efgartigimod cohort
patients treated with efgartigimod
non-efgartigimod cohort
patient treated with other MG medication
Related Therapeutic Areas
Sponsors
Leads: argenx

This content was sourced from clinicaltrials.gov