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NCT06298565 Clinical Trial

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

Myasthenia Gravis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06298565
Other study ID # ARGX-113-PASS-2208
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 2024
Est. completion date June 2034

Study information
Verified date March 2024
Source argenx
Contact Sabine Coppieters, MD
Phone 857-350-4834
Email Clinicaltrials@argenx.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 680
Est. completion date June 2034
Est. primary completion date June 2034
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Biological:
• efgartigimod
efgartigimod

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
argenx

Outcome
Type Measure Description Time frame Safety issue
Primary 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 up to 10 years
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