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A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Active Idiopathic Inflammatory Myopathy

This research study is for adults living with specific muscle conditions, such as myositis, dermatomyositis, or polymyositis. We are looking into a new medication called efgartigimod, given as an injection under the skin. The main goal is to understand if this medicine is safe and effective for long-term use in people who have already tried it in a previous study. Participants will receive the medicine for up to 51 months, and then their health will be checked for two more months after they stop taking it. This helps researchers learn more about how the medicine works over time and if it can improve the lives of those with these conditions.

En un coup d'œil

Statut
Inscription sur invitation
Phase
PHASE3
Sponsor
argenx
Objectif d'inscription
240
Démarrer
12 Sep 2023
Achèvement estimé
01 Sep 2028

De quoi parle cette étude ?

This study is investigating a new medication called efgartigimod, which is given as an injection under the skin, for adults with certain muscle diseases. These diseases are sometimes called idiopathic inflammatory myopathies, which include conditions like dermatomyositis, polymyositis, and immune-mediated necrotizing myopathy. These conditions can cause muscle weakness and other symptoms.

The main purpose of this research is to see how safe and helpful efgartigimod is over a long period. All participants in this study would have already taken part in a previous study for efgartigimod. This follow-up study helps doctors understand the long-term effects of the medication.

By taking part, you would help doctors learn more about this medication. This knowledge could potentially lead to better treatments for people with these challenging muscle conditions in the future.

Points clés

  • This study evaluates a new medication called efgartigimod for muscle conditions.
  • It's a long-term study for adults who participated in a previous trial.
  • The medication is given as an injection under the skin.
  • The main goals are to check the medication's long-term safety and effectiveness.
  • Participation helps future patients with these conditions.

Qui peut être éligible ?

To join this study, you must be an adult aged 18 or older and have previously taken part in a specific trial called ARGX-113-2007. You should be able to understand the study details and give your official consent to participate.

There are also some reasons why you might not be able to join. For example, if you plan to have major surgery during the study, or if you've developed a serious medical condition since the last study that the doctors think would make it risky for you to participate or affect the study results. You also can't take part if you are allergic to the study medicine or any of its ingredients, or if you've developed any new or returning cancer (other than a common type of skin cancer).

Cet étude pourrait-elle vous convenir ?

Répondez à ces questions rapides pour voir si vous êtes éligible. Ceci est un guide uniquement — l'équipe de recherche prend la décision finale.

  1. Avez-vous 18 ans ou plus ?
  2. Did you previously take part in the ARGX-113-2007 study?
  3. Are you able to follow study instructions and give your informed consent?
  4. Are you not planning to have major surgery during the study?
  5. Are you not allergic to the study drug or its ingredients?
  6. Have you not developed any new cancer (other than certain skin cancers)?
Répondez à chaque question pour voir votre résultat.

En quoi consiste la participation ?

If you decide to join this study, you will receive the study medication, efgartigimod, as an injection under your skin regularly for up to 51 months (about 4 years and 3 months). During this time, you will have regular visits to the clinic so doctors can monitor your health and how the medication is affecting you. After you finish taking the medication, there will be a follow-up period of about 8 weeks (56 days) where your health will continue to be checked to ensure your safety. The total duration of your involvement could be up to 53 months, including the treatment and follow-up periods.

Risques et avantages potentiels

Taking part in this study may offer potential benefits, such as continued access to a new medication for your condition and close medical monitoring. However, there are potential risks, including side effects from the medication or the need for frequent clinic visits. You can withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (92)

  • Neuromuscular Clinical and Research Center - Neurology
    Code postal vérifié
    Phoenix, États-Unis
  • Attune Health Research, Inc
    Code postal vérifié
    Beverly Hills, États-Unis
  • UCI Health - ALS and Neuromuscular Center - Neurology
    Code postal vérifié
    Orange, United States
  • UCSF Health - ALS and Neurodegenerative Disease Center - Dermatology
    Code postal vérifié
    San Francisco, États-Unis
  • Yale Cancer Center-Yale University School Of Medicine
    Code postal vérifié
    New Haven, États-Unis
  • UF Health - Rheumatology Medical Specialties Medical Plaza
    Code postal vérifié
    Gainesville, États-Unis
  • Mayo Clinic - Florida - Neurology
    Code postal vérifié
    Jacksonville, États-Unis
  • University of South Florida (USF) - Morsani Center (USF Health Carol and Frank Morsani Center for Advanced Healthcare)
    Code postal vérifié
    Tampa, États-Unis
  • Emory Healthcare - Emory Clinic - Rheumatology
    Code postal vérifié
    Atlanta, États-Unis
  • Northwestern Medicine - Northwestern Memorial Hospital
    Code postal vérifié
    Chicago, États-Unis
  • John Hopkins Medicine - Johns Hopkins Myositis Center
    Code postal vérifié
    Baltimore, États-Unis
  • Northwell Health Physician Partners Rheumatology
    Code postal vérifié
    Great Neck, United States

Questions fréquentes

What is efgartigimod?

Efgartigimod is the name of the study medication being tested for treating certain muscle conditions.

What medical conditions are being studied?

The study focuses on adult patients with specific muscle conditions, such as myositis, dermatomyositis, and polymyositis.

How is the study medicine given?

The study medicine is given as an injection under the skin.

Combien de temps vais-je participer à l'étude ?

You could be in the study for up to 51 months receiving the treatment, plus a two-month follow-up period, making the total up to roughly 4 and a half years.

Puis-je quitter l'étude à tout moment ?

Yes, you are free to leave the study at any point without having to give a reason and without your medical care being affected.

Comment en savoir plus

Parlez toujours à votre médecin généraliste ou spécialiste avant de décider de participer à une étude.

Intéressé à participer ?

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