RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-11-04
Study Completion:2034-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06298565

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Have provided appropriate written informed consent
  1. * None

Contacts and Locations

Study Contact

Sabine Coppieters, MD
CONTACT
857-350-4834
Clinicaltrials@argenx.com

Study Locations (Sites)

SFM Clinical Research, LLC
Boca Raton, Florida, 33487
United States
BayCare Health System, Inc. St Anthony's Hospital
St. Petersburg, Florida, 33705
United States
Prairie Education and Research Cooperative and HSHS Medical Group
O'Fallon, Illinois, 62701
United States
Norton Neuroscience Institute
Louisville, Kentucky, 40241
United States
National Neuromuscular Research Institute
Austin, Texas, 78759
United States

Collaborators and Investigators

Sponsor: argenx

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-04
Study Completion Date2034-06

Study Record Updates

Study Start Date2024-11-04
Study Completion Date2034-06

Terms related to this study

Additional Relevant MeSH Terms

  • Myasthenia Gravis