Safety study of patients treated with efgartigimod for Myasthenia Gravis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a non-interventional, prospective safety study focusing on patients with generalized Myasthenia Gravis (gMG) who are either starting treatment with efgartigimod or are within their first treatment cycle. The study includes two cohorts: one for patients beginning efgartigimod and another for those who have not been exposed to the treatment. The aim is to monitor the safety and tolerability of efgartigimod in real-world settings. Participants will provide informed consent before enrollment.

Why it matters

Who can join: the full rules

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

Where it's running

• UCSF Medical Center - Helen Diller Family Comprehensive Cancer Center - Brain Tumor Center,
  San Francisco, California, United States Recruiting
• SFM Clinical Research, LLC
  Boca Raton, Florida, United States Recruiting
• University of Florida College of Medicine Jacksonville
  Jacksonville Beach, Florida, United States Recruiting
• Medsol Clinical Research Center Inc
  Port Charlotte, Florida, United States Recruiting
• BayCare Health System, Inc. St Anthony's Hospital
  St. Petersburg, Florida, United States Recruiting
• Prairie Education and Research Cooperative and HSHS Medical Group
  O'Fallon, Illinois, United States Recruiting

Study contacts

• Study coordinator: Sabine Coppieters, MD
• Email: Clinicaltrials@argenx.com
• Phone: 857-350-4834

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Early ravulizumab for adults with myasthenic crisis in the ICU

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• ADAPT Forward master protocol testing multiple regimens for generalized myasthenia gravis

  This platform tests several drug regimens, including efgartigimod IV and empasiprubart IV, in adults with generalized myasthenia gravis to find safer and more effective treatment combinations.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.